<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02253160</url>
  </required_header>
  <id_info>
    <org_study_id>CTS-5038</org_study_id>
    <nct_id>NCT02253160</nct_id>
  </id_info>
  <brief_title>An Evaluation of the Spectra Optia CMNC Collection Procedure</brief_title>
  <acronym>CMNC</acronym>
  <official_title>A Randomized, Crossover Trial to Characterize the Performance of the Spectra Optia Apheresis System Versus the COBE Spectra Apheresis System for Collection of Mononuclear Cells in Healthy Adult Donors</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Terumo BCT</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Terumo BCT</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this prospective, randomized, cross-over, multi-center study is to evaluate&#xD;
      the performance of the Spectra Optia Apheresis System's CMNC Collection Procedure, compared&#xD;
      to the COBE Spectra Apheresis System's MNC Procedure in mobilized healthy donors. Subject&#xD;
      safety will be evaluated beginning with mobilization, throughout the collection procedure and&#xD;
      for the day following the last collection.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a prospective, randomized, cross-over, multi-center study to evaluate the performance&#xD;
      of the Spectra Optia system's CMNC Collection Procedure, compared to the COBE Spectra&#xD;
      system's MNC Procedure in mobilized healthy donors.&#xD;
&#xD;
      Up to 60 subject may be consented to meet the the enrollment target of 20 complete subjects.&#xD;
      Eligible subjects will be randomized to receive either the Spectra Optia CMNC or the COBE&#xD;
      Spectra MNC collection procedure first, followed by the opposite on the following day.&#xD;
&#xD;
      Study participation will be up to 14 days: a 7-day screening period, four days for&#xD;
      mobilization, one day for the first MNC collection with additional dose of mobilization, one&#xD;
      day for the second MNC collection, and safety follow-up the following day.&#xD;
&#xD;
      Subject safety will be evaluated beginning with mobilization, throughout the collection&#xD;
      procedure and for the day following the second collection.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">January 2015</completion_date>
  <primary_completion_date type="Actual">January 2015</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>CD34+ Collection Efficiency (CE1 %)</measure>
    <time_frame>within 5 minutes upon completion of procedure</time_frame>
    <description>The primary endpoint is the CD34+ cell collection efficiency (CE) associated with the Mononuclear Cell (CMNC) Collection Procedures on the Spectra Optia and COBE Spectra Apheresis Systems. CE is a measurement of device performance calculated using donor and blood product blood counts collected immediately before and after the CMNC collection procedure. The collection efficiency for a given cell type is defined as the percent of processed cells of that cell type that are in fact collected.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>CD34+ Collection Efficiency (CE2 %)</measure>
    <time_frame>within 5 minutes upon completion of procedure</time_frame>
    <description>Comparison of collection efficiencies associated with the CMNC Cell Collection Procedures on the Spectra Optia and COBE Spectra Apheresis Systems. CE is a measurement of device performance calculated using donor blood counts immediately before and blood product blood counts immediately after the collection procedure. The collection efficiency for a given cell type is defined as the percent of processed cells of that cell type that are in fact collected.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>MNC Collection Efficiency (CE1%)</measure>
    <time_frame>within 5 minutes upon completion of procedure</time_frame>
    <description>Comparison of collection efficiencies associated with the CMNC Collection Procedures on the Spectra Optia and COBE Spectra Apheresis Systems for MNCs. CE1 is a measurement of device performance calculated using donor and blood product blood counts collected immediately before and after the collection procedure. The collection efficiency for a given cell type is defined as the percent of processed cells of that cell type that are in fact collected.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CD34+ Per kg of Body Weight</measure>
    <time_frame>within 5 minutes upon completion of procedure</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>MNC Product Contamination/Purity (%) - Hematocrit (%)</measure>
    <time_frame>within 5 minutes upon completion of procedure</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>MNC Product Contamination/Purity (%) - Granulocyte Concentration (10^3/mL)</measure>
    <time_frame>within 5 minutes upon completion of procedure</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>MNC Product Contamination/Purity (%) - Platelet Concentration (10^3/µL)</measure>
    <time_frame>within 5 minutes upon completion of procedure</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>MNC Product Contamination/Purity (%) - Platelet Collection Efficiency (CE1 %)</measure>
    <time_frame>within 5 minutes upon completion of procedure</time_frame>
    <description>Comparison of collection efficiencies associated with the CMNC Collection Procedures on the Spectra Optia and COBE Spectra Apheresis Systems for platelets. CE1 is a measurement of device performance calculated using donor and blood product blood counts collected immediately before and after the collection procedure. The collection efficiency for a given cell type is defined as the percent of processed cells of that cell type that are in fact collected.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>MNC Blood Product Volume (mL)</measure>
    <time_frame>within 5 minutes upon completion of procedure</time_frame>
    <description>The produced unit of MNCs collected into the blood bag.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Purity of Plasma Collected for Laboratory Processing of MNC Product - Platelet Concentration in Plasma (10^3/µL)</measure>
    <time_frame>within 5 minutes upon completion of procedure</time_frame>
    <description>A small amount of plasma typically used for processing was collected in a sub-set of collection procedures.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Procedure Time (Minutes)</measure>
    <time_frame>within 5 minutes upon completion of procedure</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>MNC Collection Efficiency (CE2%)</measure>
    <time_frame>within 5 minutes upon completion of procedure</time_frame>
    <description>Comparison of collection efficiencies associated with the CMNC Collection Procedures on the Spectra Optia and COBE Spectra Apheresis Systems for MNCs. CE2 is a measurement of device performance calculated using donor blood counts immediately before and blood product counts immediately after the collection procedure and does not average the donor pre- and post-collection counts. The collection efficiency for a given cell type is defined as the percent of processed cells of that cell type that are in fact collected.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>MNC Product Contamination/Purity - RBC Concentration (10^6/µL)</measure>
    <time_frame>within 5 minutes upon completion of procedure</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Device Deficiencies</measure>
    <time_frame>24-hours after last collection procedure</time_frame>
    <description>Any time a device or disposable does not function as described in the Operator's Manual or Package Insert, a Device Deficiency must be reported. This includes those instances wherein Operator Error led to a malfunction/deficiency. A device deficiency is any inadequacy in the identity, quality, durability, reliability, safety or performance of an investigational device, including malfunction, use errors or inadequacy in the information supplied by the manufacturer. Device malfunctions and device incidents should be reported in the same manner.</description>
  </other_outcome>
  <other_outcome>
    <measure>Post-collection Platelet Loss in Subject</measure>
    <time_frame>24-hours after last collection procedure</time_frame>
    <description>The percent change from pre-collection platelet count to post-collection subject platelet count.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">23</enrollment>
  <condition>Healthy Apheresis Donors</condition>
  <condition>Mononuclear (MNC) Cell Donors</condition>
  <arm_group>
    <arm_group_label>Spectra Optia CMNC first, then COBE Spectra MNC</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Spectra Optia CMNC collection procedure followed by COBE Spectra MNC collection procedure.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>COBE Spectra MNC first, then Spectra Optia CMNC</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>COBE Spectra MNC collection procedure followed by Spectra Optia CMNC collection procedure.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Spectra Optia CMNC</intervention_name>
    <description>The Spectra Optia® Apheresis System is an automated centrifugal system that separates whole blood into its cellular and plasma components. The device is comprised of three major sub-systems, 1) the apheresis machine itself (centrifuge, centrifuge filler, pumps, valves, computerized safety and control systems, etc.), 2) a sterile, single-use, disposable blood tubing set, and 3) embedded software. The Spectra Optia system's investigational CMNC procedure will be used to collect MNC from the peripheral blood.</description>
    <arm_group_label>COBE Spectra MNC first, then Spectra Optia CMNC</arm_group_label>
    <arm_group_label>Spectra Optia CMNC first, then COBE Spectra MNC</arm_group_label>
    <other_name>Spectra Optia Apheresis System CMNC collection procedure</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>COBE Spectra MNC</intervention_name>
    <description>It is also a centrifugal system that separates whole blood into its cellular and plasma components. The COBE Spectra MNC collection procedure is chosen as the comparator device because it is the reference after which design of the Spectra Optia CMNC collection procedure was modeled.</description>
    <arm_group_label>COBE Spectra MNC first, then Spectra Optia CMNC</arm_group_label>
    <arm_group_label>Spectra Optia CMNC first, then COBE Spectra MNC</arm_group_label>
    <other_name>COBE Spectra Apheresis System MNC collection procedure</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Granulocyte-colony stimulating factor (G-CSF)</intervention_name>
    <description>Each subject received an injection of the G-CSF approximately equivalent to 10 ug/kg body weight subcutaneous per day for 5 days prior to the MNC collection procedure.</description>
    <arm_group_label>COBE Spectra MNC first, then Spectra Optia CMNC</arm_group_label>
    <arm_group_label>Spectra Optia CMNC first, then COBE Spectra MNC</arm_group_label>
    <other_name>Mobilization Procedure</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. ≥ 18 and ≤ 50 years of age&#xD;
&#xD;
          2. Healthy blood donor criteria as defined by the American Associate of Blood Banks&#xD;
             (AABB)&#xD;
&#xD;
             a) Note: Subjects who are deferred from volunteer donations because of travel&#xD;
             restrictions, piercings or tattoos may participate in the study&#xD;
&#xD;
          3. Adequate dual peripheral venous access&#xD;
&#xD;
          4. Acceptable prescreening laboratory results prior to MNC mobilization as specified&#xD;
             below:&#xD;
&#xD;
             a) WBC 3,500 - 10,800/µL&#xD;
&#xD;
             b) Hematocrit 38% - 56%&#xD;
&#xD;
             c) Platelets 150,000 - 400,000/µL&#xD;
&#xD;
             d) Coagulation tests:&#xD;
&#xD;
             i. PT 9.0 - 13.0 seconds&#xD;
&#xD;
             ii. PTT 23.4 - 41.8 seconds&#xD;
&#xD;
             e) Serum electrolytes:&#xD;
&#xD;
             i. Potassium 3.6 - 5.1 mmol/L&#xD;
&#xD;
             ii. Serum Calcium 8.5 mg/dL - 10.3 mg/dL&#xD;
&#xD;
             f) Renal function: Serum creatinine ≤ 1.5 mg/dL&#xD;
&#xD;
             NOTE: up to two laboratory results may fall out of the ranges listed above if, in the&#xD;
             judgment of the investigator, they do not constitute a significant risk to the&#xD;
             subject.&#xD;
&#xD;
          5. Liver function: alanine aminotransferase (ALT) &lt; 1.5 times the upper limit of normal&#xD;
&#xD;
          6. Willing to avoid pregnancy until at least 48 hours following last G-CSF injection&#xD;
&#xD;
               1. If male, be willing to use a condom during sexual relations with a female partner&#xD;
                  until 48 hours following the last G-CSF injection&#xD;
&#xD;
               2. If female and of childbearing potential, be willing to use a medically acceptable&#xD;
                  contraceptive until 48 hours following the last G-CSF injection&#xD;
&#xD;
          7. Given written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Previous MNC collection failure&#xD;
&#xD;
          2. Known hypersensitivity or condition that prevents the use of anticoagulants&#xD;
&#xD;
          3. Known hypersensitivity or condition that prevents the use of G-CSF&#xD;
&#xD;
          4. Known hemoglobinopathy including sickle cell trait or disease&#xD;
&#xD;
          5. History of use in the past week or anticipated need for lithium&#xD;
&#xD;
          6. Concurrent enrollment in another clinical study that could impact the results or&#xD;
             participation in this study&#xD;
&#xD;
          7. Active infection or any serious underlying medical condition that contraindicates&#xD;
             apheresis&#xD;
&#xD;
          8. Women who are pregnant or lactating&#xD;
&#xD;
          9. Known history of significant head trauma&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Raymond Goodrich, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Terumo BCT</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hoxworth Blood Center</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45267-0055</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Key Biologics, LLC</name>
      <address>
        <city>Memphis</city>
        <state>Tennessee</state>
        <zip>38104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2015</verification_date>
  <study_first_submitted>September 23, 2014</study_first_submitted>
  <study_first_submitted_qc>September 26, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 1, 2014</study_first_posted>
  <results_first_submitted>May 5, 2015</results_first_submitted>
  <results_first_submitted_qc>August 24, 2015</results_first_submitted_qc>
  <results_first_posted type="Estimate">September 24, 2015</results_first_posted>
  <last_update_submitted>August 24, 2015</last_update_submitted>
  <last_update_submitted_qc>August 24, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 24, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>MNCs</keyword>
  <keyword>Mononuclear Cells</keyword>
  <keyword>Apheresis</keyword>
  <keyword>Spectra Optia</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lenograstim</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Subjects were recruited from the specialized donor population of blood centers from August 2014 through January 2015.</recruitment_details>
      <pre_assignment_details>A lead-in phase was used to allow for investigational device training. One subject consented the lead-in phase and was included in the safety analysis only. After a screening period to evaluate and confirm eligibility criteria prior to enrollment &amp; randomization to treatment assignment (Arm 1 or Arm 2) 22 subjects enrolled in the pivotal study.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Lead-in Donor</title>
          <description>Subjects screened and enrolled for the purpose of training on the investigational procedure only. Included in safety analysis only.</description>
        </group>
        <group group_id="P2">
          <title>Spectra Optia CMNC First, Then COBE Spectra MNC</title>
          <description>Spectra Optia CMNC collection procedure followed by COBE Spectra MNC collection procedure.&#xD;
Spectra Optia CMNC: The Spectra Optia® Apheresis System is an automated centrifugal system that separates whole blood into its cellular and plasma components. The device is comprised of three major sub-systems, 1) the apheresis machine itself (centrifuge, centrifuge filler, pumps, valves, computerized safety and control systems, etc.), 2) a sterile, single-use, disposable blood tubing set, and 3) embedded software. The Spectra Optia system's investigational CMNC procedure will be used to collect MNC from the peripheral blood.&#xD;
COBE Spectra MNC: It is also a centrifugal system that separates whole blood into its cellular and plasma components. The COBE Spectra MNC collection procedure is chosen as the comparator device because it is the reference after which design of the Spectra Optia CMNC collection procedure was modeled.</description>
        </group>
        <group group_id="P3">
          <title>COBE Spectra MNC First, Then Spectra Optia CMNC</title>
          <description>COBE Spectra MNC collection procedure followed by Spectra Optia CMNC collection procedure.&#xD;
Spectra Optia CMNC: The Spectra Optia® Apheresis System is an automated centrifugal system that separates whole blood into its cellular and plasma components. The device is comprised of three major sub-systems, 1) the apheresis machine itself (centrifuge, centrifuge filler, pumps, valves, computerized safety and control systems, etc.), 2) a sterile, single-use, disposable blood tubing set, and 3) embedded software. The Spectra Optia system's investigational CMNC procedure will be used to collect MNC from the peripheral blood.&#xD;
COBE Spectra MNC: It is also a centrifugal system that separates whole blood into its cellular and plasma components. The COBE Spectra MNC collection procedure is chosen as the comparator device because it is the reference after which design of the Spectra Optia CMNC collection procedure was modeled.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="12"/>
                <participants group_id="P3" count="10"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="12"/>
                <participants group_id="P3" count="10"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Healthy adult specialized blood donors</population>
      <group_list>
        <group group_id="B1">
          <title>Lead-in Donor</title>
          <description>Subjects screened and enrolled for the purpose of training on the investigational procedure only. Included in safety analysis only.</description>
        </group>
        <group group_id="B2">
          <title>Spectra Optia CMNC First, Then COBE Spectra MNC</title>
          <description>Spectra Optia CMNC collection procedure followed by COBE Spectra MNC collection procedure.&#xD;
Spectra Optia CMNC: The Spectra Optia® Apheresis System is an automated centrifugal system that separates whole blood into its cellular and plasma components. The device is comprised of three major sub-systems, 1) the apheresis machine itself (centrifuge, centrifuge filler, pumps, valves, computerized safety and control systems, etc.), 2) a sterile, single-use, disposable blood tubing set, and 3) embedded software. The Spectra Optia system's investigational CMNC procedure will be used to collect MNC from the peripheral blood.&#xD;
COBE Spectra MNC: It is also a centrifugal system that separates whole blood into its cellular and plasma components. The COBE Spectra MNC collection procedure is chosen as the comparator device because it is the reference after which design of the Spectra Optia CMNC collection procedure was modeled.</description>
        </group>
        <group group_id="B3">
          <title>COBE Spectra MNC First, Then Spectra Optia CMNC</title>
          <description>COBE Spectra MNC collection procedure followed by Spectra Optia CMNC collection procedure.&#xD;
Spectra Optia CMNC: The Spectra Optia® Apheresis System is an automated centrifugal system that separates whole blood into its cellular and plasma components. The device is comprised of three major sub-systems, 1) the apheresis machine itself (centrifuge, centrifuge filler, pumps, valves, computerized safety and control systems, etc.), 2) a sterile, single-use, disposable blood tubing set, and 3) embedded software. The Spectra Optia system's investigational CMNC procedure will be used to collect MNC from the peripheral blood.&#xD;
COBE Spectra MNC: It is also a centrifugal system that separates whole blood into its cellular and plasma components. The COBE Spectra MNC collection procedure is chosen as the comparator device because it is the reference after which design of the Spectra Optia CMNC collection procedure was modeled.</description>
        </group>
        <group group_id="B4">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="1"/>
            <count group_id="B2" value="12"/>
            <count group_id="B3" value="10"/>
            <count group_id="B4" value="23"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="32" spread="NA">no s.d. available when n=1</measurement>
                    <measurement group_id="B2" value="35.4" spread="7.32"/>
                    <measurement group_id="B3" value="34.8" spread="8.44"/>
                    <measurement group_id="B4" value="35.0" spread="7.51"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="8"/>
                    <measurement group_id="B4" value="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="10"/>
                    <measurement group_id="B4" value="23"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="6"/>
                    <measurement group_id="B4" value="12"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="4"/>
                    <measurement group_id="B4" value="10"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Weight</title>
          <units>kilograms</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="110" spread="NA">no s.d. available when n=1</measurement>
                    <measurement group_id="B2" value="115.23" spread="28.921"/>
                    <measurement group_id="B3" value="97.08" spread="26.654"/>
                    <measurement group_id="B4" value="107.11" spread="28.124"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Height</title>
          <units>inches</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="60" spread="NA">no s.d. available when n=1</measurement>
                    <measurement group_id="B2" value="70.8" spread="2.45"/>
                    <measurement group_id="B3" value="69.4" spread="4.06"/>
                    <measurement group_id="B4" value="69.7" spread="3.83"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>BMI</title>
          <units>kg/m^2</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="47.36" spread="NA">no s.d. available when n=1</measurement>
                    <measurement group_id="B2" value="35.82" spread="9.413"/>
                    <measurement group_id="B3" value="30.88" spread="6.050"/>
                    <measurement group_id="B4" value="34.17" spread="8.579"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>CD34+ Collection Efficiency (CE1 %)</title>
        <description>The primary endpoint is the CD34+ cell collection efficiency (CE) associated with the Mononuclear Cell (CMNC) Collection Procedures on the Spectra Optia and COBE Spectra Apheresis Systems. CE is a measurement of device performance calculated using donor and blood product blood counts collected immediately before and after the CMNC collection procedure. The collection efficiency for a given cell type is defined as the percent of processed cells of that cell type that are in fact collected.</description>
        <time_frame>within 5 minutes upon completion of procedure</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Treatment Assignment 1</title>
            <description>Spectra Optia CMNC collection procedure followed by COBE Spectra MNC collection procedure.&#xD;
Spectra Optia CMNC: The Spectra Optia® Apheresis System is an automated centrifugal system that separates whole blood into its cellular and plasma components. The device is comprised of three major sub-systems, 1) the apheresis machine itself (centrifuge, centrifuge filler, pumps, valves, computerized safety and control systems, etc.), 2) a sterile, single-use, disposable blood tubing set, and 3) embedded software. The Spectra Optia system's investigational CMNC procedure will be used to collect MNC from the peripheral blood.&#xD;
COBE Spectra MNC: It is also a centrifugal system that separates whole blood into its cellular and plasma components. The COBE Spectra MNC collection procedure is chosen as the comparator device because it is the reference after which design of the Spectra Optia CMNC collection procedure was modeled.</description>
          </group>
          <group group_id="O2">
            <title>Treatment Assignment 2</title>
            <description>COBE Spectra MNC collection procedure followed by Spectra Optia CMNC collection procedure.&#xD;
Spectra Optia CMNC: The Spectra Optia® Apheresis System is an automated centrifugal system that separates whole blood into its cellular and plasma components. The device is comprised of three major sub-systems, 1) the apheresis machine itself (centrifuge, centrifuge filler, pumps, valves, computerized safety and control systems, etc.), 2) a sterile, single-use, disposable blood tubing set, and 3) embedded software. The Spectra Optia system's investigational CMNC procedure will be used to collect MNC from the peripheral blood.&#xD;
COBE Spectra MNC: It is also a centrifugal system that separates whole blood into its cellular and plasma components. The COBE Spectra MNC collection procedure is chosen as the comparator device because it is the reference after which design of the Spectra Optia CMNC collection procedure was modeled.</description>
          </group>
        </group_list>
        <measure>
          <title>CD34+ Collection Efficiency (CE1 %)</title>
          <description>The primary endpoint is the CD34+ cell collection efficiency (CE) associated with the Mononuclear Cell (CMNC) Collection Procedures on the Spectra Optia and COBE Spectra Apheresis Systems. CE is a measurement of device performance calculated using donor and blood product blood counts collected immediately before and after the CMNC collection procedure. The collection efficiency for a given cell type is defined as the percent of processed cells of that cell type that are in fact collected.</description>
          <units>percent</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Spectra Optia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="87.7" spread="20.18"/>
                    <measurement group_id="O2" value="81.4" spread="10.24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>COBE Spectra</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="66.6" spread="20.26"/>
                    <measurement group_id="O2" value="65.8" spread="6.40"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>CD34+ Collection Efficiency (CE2 %)</title>
        <description>Comparison of collection efficiencies associated with the CMNC Cell Collection Procedures on the Spectra Optia and COBE Spectra Apheresis Systems. CE is a measurement of device performance calculated using donor blood counts immediately before and blood product blood counts immediately after the collection procedure. The collection efficiency for a given cell type is defined as the percent of processed cells of that cell type that are in fact collected.</description>
        <time_frame>within 5 minutes upon completion of procedure</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Treatment Assignment 1</title>
            <description>Spectra Optia CMNC collection procedure followed by COBE Spectra MNC collection procedure.&#xD;
Spectra Optia CMNC: The Spectra Optia® Apheresis System is an automated centrifugal system that separates whole blood into its cellular and plasma components. The device is comprised of three major sub-systems, 1) the apheresis machine itself (centrifuge, centrifuge filler, pumps, valves, computerized safety and control systems, etc.), 2) a sterile, single-use, disposable blood tubing set, and 3) embedded software. The Spectra Optia system's investigational CMNC procedure will be used to collect MNC from the peripheral blood.&#xD;
COBE Spectra MNC: It is also a centrifugal system that separates whole blood into its cellular and plasma components. The COBE Spectra MNC collection procedure is chosen as the comparator device because it is the reference after which design of the Spectra Optia CMNC collection procedure was modeled.</description>
          </group>
          <group group_id="O2">
            <title>Treatment Assignment 2</title>
            <description>COBE Spectra MNC collection procedure followed by Spectra Optia CMNC collection procedure.&#xD;
Spectra Optia CMNC: The Spectra Optia® Apheresis System is an automated centrifugal system that separates whole blood into its cellular and plasma components. The device is comprised of three major sub-systems, 1) the apheresis machine itself (centrifuge, centrifuge filler, pumps, valves, computerized safety and control systems, etc.), 2) a sterile, single-use, disposable blood tubing set, and 3) embedded software. The Spectra Optia system's investigational CMNC procedure will be used to collect MNC from the peripheral blood.&#xD;
COBE Spectra MNC: It is also a centrifugal system that separates whole blood into its cellular and plasma components. The COBE Spectra MNC collection procedure is chosen as the comparator device because it is the reference after which design of the Spectra Optia CMNC collection procedure was modeled.</description>
          </group>
        </group_list>
        <measure>
          <title>CD34+ Collection Efficiency (CE2 %)</title>
          <description>Comparison of collection efficiencies associated with the CMNC Cell Collection Procedures on the Spectra Optia and COBE Spectra Apheresis Systems. CE is a measurement of device performance calculated using donor blood counts immediately before and blood product blood counts immediately after the collection procedure. The collection efficiency for a given cell type is defined as the percent of processed cells of that cell type that are in fact collected.</description>
          <units>percent</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Spectra Optia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="64.7" spread="14.61"/>
                    <measurement group_id="O2" value="59.6" spread="6.17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>COBE Spectra</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="47.0" spread="14.86"/>
                    <measurement group_id="O2" value="50.2" spread="4.20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>MNC Collection Efficiency (CE1%)</title>
        <description>Comparison of collection efficiencies associated with the CMNC Collection Procedures on the Spectra Optia and COBE Spectra Apheresis Systems for MNCs. CE1 is a measurement of device performance calculated using donor and blood product blood counts collected immediately before and after the collection procedure. The collection efficiency for a given cell type is defined as the percent of processed cells of that cell type that are in fact collected.</description>
        <time_frame>within 5 minutes upon completion of procedure</time_frame>
        <population>One subject was not included in MNC CE1 because of missing MNC lab results post-collection, therefore CE1 could not be calculated.</population>
        <group_list>
          <group group_id="O1">
            <title>Treatment Assignment 1</title>
            <description>Spectra Optia CMNC collection procedure followed by COBE Spectra MNC collection procedure.&#xD;
Spectra Optia CMNC: The Spectra Optia® Apheresis System is an automated centrifugal system that separates whole blood into its cellular and plasma components. The device is comprised of three major sub-systems, 1) the apheresis machine itself (centrifuge, centrifuge filler, pumps, valves, computerized safety and control systems, etc.), 2) a sterile, single-use, disposable blood tubing set, and 3) embedded software. The Spectra Optia system's investigational CMNC procedure will be used to collect MNC from the peripheral blood.&#xD;
COBE Spectra MNC: It is also a centrifugal system that separates whole blood into its cellular and plasma components. The COBE Spectra MNC collection procedure is chosen as the comparator device because it is the reference after which design of the Spectra Optia CMNC collection procedure was modeled.</description>
          </group>
          <group group_id="O2">
            <title>Treatment Assignment 2</title>
            <description>COBE Spectra MNC collection procedure followed by Spectra Optia CMNC collection procedure.&#xD;
Spectra Optia CMNC: The Spectra Optia® Apheresis System is an automated centrifugal system that separates whole blood into its cellular and plasma components. The device is comprised of three major sub-systems, 1) the apheresis machine itself (centrifuge, centrifuge filler, pumps, valves, computerized safety and control systems, etc.), 2) a sterile, single-use, disposable blood tubing set, and 3) embedded software. The Spectra Optia system's investigational CMNC procedure will be used to collect MNC from the peripheral blood.&#xD;
COBE Spectra MNC: It is also a centrifugal system that separates whole blood into its cellular and plasma components. The COBE Spectra MNC collection procedure is chosen as the comparator device because it is the reference after which design of the Spectra Optia CMNC collection procedure was modeled.</description>
          </group>
        </group_list>
        <measure>
          <title>MNC Collection Efficiency (CE1%)</title>
          <description>Comparison of collection efficiencies associated with the CMNC Collection Procedures on the Spectra Optia and COBE Spectra Apheresis Systems for MNCs. CE1 is a measurement of device performance calculated using donor and blood product blood counts collected immediately before and after the collection procedure. The collection efficiency for a given cell type is defined as the percent of processed cells of that cell type that are in fact collected.</description>
          <population>One subject was not included in MNC CE1 because of missing MNC lab results post-collection, therefore CE1 could not be calculated.</population>
          <units>percent</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="11"/>
                <count group_id="O2" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Spectra Optia CE1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="62.06" spread="17.220"/>
                    <measurement group_id="O2" value="63.75" spread="18.900"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>COBE Spectra CE1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="45.46" spread="6.483"/>
                    <measurement group_id="O2" value="48.58" spread="14.685"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>CD34+ Per kg of Body Weight</title>
        <time_frame>within 5 minutes upon completion of procedure</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Treatment Assignment 1</title>
            <description>Spectra Optia CMNC collection procedure followed by COBE Spectra MNC collection procedure.&#xD;
Spectra Optia CMNC: The Spectra Optia® Apheresis System is an automated centrifugal system that separates whole blood into its cellular and plasma components. The device is comprised of three major sub-systems, 1) the apheresis machine itself (centrifuge, centrifuge filler, pumps, valves, computerized safety and control systems, etc.), 2) a sterile, single-use, disposable blood tubing set, and 3) embedded software. The Spectra Optia system's investigational CMNC procedure will be used to collect MNC from the peripheral blood.&#xD;
COBE Spectra MNC: It is also a centrifugal system that separates whole blood into its cellular and plasma components. The COBE Spectra MNC collection procedure is chosen as the comparator device because it is the reference after which design of the Spectra Optia CMNC collection procedure was modeled.</description>
          </group>
          <group group_id="O2">
            <title>Treatment Assignment 2</title>
            <description>COBE Spectra MNC collection procedure followed by Spectra Optia CMNC collection procedure.&#xD;
Spectra Optia CMNC: The Spectra Optia® Apheresis System is an automated centrifugal system that separates whole blood into its cellular and plasma components. The device is comprised of three major sub-systems, 1) the apheresis machine itself (centrifuge, centrifuge filler, pumps, valves, computerized safety and control systems, etc.), 2) a sterile, single-use, disposable blood tubing set, and 3) embedded software. The Spectra Optia system's investigational CMNC procedure will be used to collect MNC from the peripheral blood.&#xD;
COBE Spectra MNC: It is also a centrifugal system that separates whole blood into its cellular and plasma components. The COBE Spectra MNC collection procedure is chosen as the comparator device because it is the reference after which design of the Spectra Optia CMNC collection procedure was modeled.</description>
          </group>
        </group_list>
        <measure>
          <title>CD34+ Per kg of Body Weight</title>
          <units>cells/kg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Spectra Optia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.14" spread="3.756"/>
                    <measurement group_id="O2" value="3.75" spread="1.506"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>COBE Spectra</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.50" spread="2.732"/>
                    <measurement group_id="O2" value="3.68" spread="1.546"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>MNC Product Contamination/Purity (%) - Hematocrit (%)</title>
        <time_frame>within 5 minutes upon completion of procedure</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Treatment Assignment 1</title>
            <description>Spectra Optia CMNC collection procedure followed by COBE Spectra MNC collection procedure.&#xD;
Spectra Optia CMNC: The Spectra Optia® Apheresis System is an automated centrifugal system that separates whole blood into its cellular and plasma components. The device is comprised of three major sub-systems, 1) the apheresis machine itself (centrifuge, centrifuge filler, pumps, valves, computerized safety and control systems, etc.), 2) a sterile, single-use, disposable blood tubing set, and 3) embedded software. The Spectra Optia system's investigational CMNC procedure will be used to collect MNC from the peripheral blood.&#xD;
COBE Spectra MNC: It is also a centrifugal system that separates whole blood into its cellular and plasma components. The COBE Spectra MNC collection procedure is chosen as the comparator device because it is the reference after which design of the Spectra Optia CMNC collection procedure was modeled.</description>
          </group>
          <group group_id="O2">
            <title>Treatment Assignment 2</title>
            <description>COBE Spectra MNC collection procedure followed by Spectra Optia CMNC collection procedure.&#xD;
Spectra Optia CMNC: The Spectra Optia® Apheresis System is an automated centrifugal system that separates whole blood into its cellular and plasma components. The device is comprised of three major sub-systems, 1) the apheresis machine itself (centrifuge, centrifuge filler, pumps, valves, computerized safety and control systems, etc.), 2) a sterile, single-use, disposable blood tubing set, and 3) embedded software. The Spectra Optia system's investigational CMNC procedure will be used to collect MNC from the peripheral blood.&#xD;
COBE Spectra MNC: It is also a centrifugal system that separates whole blood into its cellular and plasma components. The COBE Spectra MNC collection procedure is chosen as the comparator device because it is the reference after which design of the Spectra Optia CMNC collection procedure was modeled.</description>
          </group>
        </group_list>
        <measure>
          <title>MNC Product Contamination/Purity (%) - Hematocrit (%)</title>
          <units>% of red blood cells</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Spectra Optia Hematocrit</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.1" spread="2.12"/>
                    <measurement group_id="O2" value="3.7" spread="0.95"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>COBE Spectra Hematocrit</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.5" spread="1.54"/>
                    <measurement group_id="O2" value="5.7" spread="1.71"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>MNC Product Contamination/Purity (%) - Granulocyte Concentration (10^3/mL)</title>
        <time_frame>within 5 minutes upon completion of procedure</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Treatment Assignment 1</title>
            <description>Spectra Optia CMNC collection procedure followed by COBE Spectra MNC collection procedure.&#xD;
Spectra Optia CMNC: The Spectra Optia® Apheresis System is an automated centrifugal system that separates whole blood into its cellular and plasma components. The device is comprised of three major sub-systems, 1) the apheresis machine itself (centrifuge, centrifuge filler, pumps, valves, computerized safety and control systems, etc.), 2) a sterile, single-use, disposable blood tubing set, and 3) embedded software. The Spectra Optia system's investigational CMNC procedure will be used to collect MNC from the peripheral blood.&#xD;
COBE Spectra MNC: It is also a centrifugal system that separates whole blood into its cellular and plasma components. The COBE Spectra MNC collection procedure is chosen as the comparator device because it is the reference after which design of the Spectra Optia CMNC collection procedure was modeled.</description>
          </group>
          <group group_id="O2">
            <title>Treatment Assignment 2</title>
            <description>COBE Spectra MNC collection procedure followed by Spectra Optia CMNC collection procedure.&#xD;
Spectra Optia CMNC: The Spectra Optia® Apheresis System is an automated centrifugal system that separates whole blood into its cellular and plasma components. The device is comprised of three major sub-systems, 1) the apheresis machine itself (centrifuge, centrifuge filler, pumps, valves, computerized safety and control systems, etc.), 2) a sterile, single-use, disposable blood tubing set, and 3) embedded software. The Spectra Optia system's investigational CMNC procedure will be used to collect MNC from the peripheral blood.&#xD;
COBE Spectra MNC: It is also a centrifugal system that separates whole blood into its cellular and plasma components. The COBE Spectra MNC collection procedure is chosen as the comparator device because it is the reference after which design of the Spectra Optia CMNC collection procedure was modeled.</description>
          </group>
        </group_list>
        <measure>
          <title>MNC Product Contamination/Purity (%) - Granulocyte Concentration (10^3/mL)</title>
          <units>cells*10^3/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Spectra Optia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="51.689" spread="35.5970"/>
                    <measurement group_id="O2" value="63.338" spread="44.9682"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>COBE Spectra</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="83.792" spread="58.9491"/>
                    <measurement group_id="O2" value="70.944" spread="72.4223"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>MNC Product Contamination/Purity (%) - Platelet Concentration (10^3/µL)</title>
        <time_frame>within 5 minutes upon completion of procedure</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Treatment Assignment 1</title>
            <description>Spectra Optia CMNC collection procedure followed by COBE Spectra MNC collection procedure.&#xD;
Spectra Optia CMNC: The Spectra Optia® Apheresis System is an automated centrifugal system that separates whole blood into its cellular and plasma components. The device is comprised of three major sub-systems, 1) the apheresis machine itself (centrifuge, centrifuge filler, pumps, valves, computerized safety and control systems, etc.), 2) a sterile, single-use, disposable blood tubing set, and 3) embedded software. The Spectra Optia system's investigational CMNC procedure will be used to collect MNC from the peripheral blood.&#xD;
COBE Spectra MNC: It is also a centrifugal system that separates whole blood into its cellular and plasma components. The COBE Spectra MNC collection procedure is chosen as the comparator device because it is the reference after which design of the Spectra Optia CMNC collection procedure was modeled.</description>
          </group>
          <group group_id="O2">
            <title>Treatment Assignment 2</title>
            <description>COBE Spectra MNC collection procedure followed by Spectra Optia CMNC collection procedure.&#xD;
Spectra Optia CMNC: The Spectra Optia® Apheresis System is an automated centrifugal system that separates whole blood into its cellular and plasma components. The device is comprised of three major sub-systems, 1) the apheresis machine itself (centrifuge, centrifuge filler, pumps, valves, computerized safety and control systems, etc.), 2) a sterile, single-use, disposable blood tubing set, and 3) embedded software. The Spectra Optia system's investigational CMNC procedure will be used to collect MNC from the peripheral blood.&#xD;
COBE Spectra MNC: It is also a centrifugal system that separates whole blood into its cellular and plasma components. The COBE Spectra MNC collection procedure is chosen as the comparator device because it is the reference after which design of the Spectra Optia CMNC collection procedure was modeled.</description>
          </group>
        </group_list>
        <measure>
          <title>MNC Product Contamination/Purity (%) - Platelet Concentration (10^3/µL)</title>
          <units>cells*10^3/µL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Spectra Optia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3724.9" spread="962.42"/>
                    <measurement group_id="O2" value="2022.9" spread="674.91"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>COBE Spectra</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2857.4" spread="467.44"/>
                    <measurement group_id="O2" value="3736.0" spread="1200.88"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>MNC Product Contamination/Purity (%) - Platelet Collection Efficiency (CE1 %)</title>
        <description>Comparison of collection efficiencies associated with the CMNC Collection Procedures on the Spectra Optia and COBE Spectra Apheresis Systems for platelets. CE1 is a measurement of device performance calculated using donor and blood product blood counts collected immediately before and after the collection procedure. The collection efficiency for a given cell type is defined as the percent of processed cells of that cell type that are in fact collected.</description>
        <time_frame>within 5 minutes upon completion of procedure</time_frame>
        <population>One subject was not included in MNC CE1 because of missing MNC lab results post-collection, therefore CE1 could not be calculated.</population>
        <group_list>
          <group group_id="O1">
            <title>Treatment Assignment 1</title>
            <description>Spectra Optia CMNC collection procedure followed by COBE Spectra MNC collection procedure.&#xD;
Spectra Optia CMNC: The Spectra Optia® Apheresis System is an automated centrifugal system that separates whole blood into its cellular and plasma components. The device is comprised of three major sub-systems, 1) the apheresis machine itself (centrifuge, centrifuge filler, pumps, valves, computerized safety and control systems, etc.), 2) a sterile, single-use, disposable blood tubing set, and 3) embedded software. The Spectra Optia system's investigational CMNC procedure will be used to collect MNC from the peripheral blood.&#xD;
COBE Spectra MNC: It is also a centrifugal system that separates whole blood into its cellular and plasma components. The COBE Spectra MNC collection procedure is chosen as the comparator device because it is the reference after which design of the Spectra Optia CMNC collection procedure was modeled.</description>
          </group>
          <group group_id="O2">
            <title>Treatment Assignment 2</title>
            <description>COBE Spectra MNC collection procedure followed by Spectra Optia CMNC collection procedure.&#xD;
Spectra Optia CMNC: The Spectra Optia® Apheresis System is an automated centrifugal system that separates whole blood into its cellular and plasma components. The device is comprised of three major sub-systems, 1) the apheresis machine itself (centrifuge, centrifuge filler, pumps, valves, computerized safety and control systems, etc.), 2) a sterile, single-use, disposable blood tubing set, and 3) embedded software. The Spectra Optia system's investigational CMNC procedure will be used to collect MNC from the peripheral blood.&#xD;
COBE Spectra MNC: It is also a centrifugal system that separates whole blood into its cellular and plasma components. The COBE Spectra MNC collection procedure is chosen as the comparator device because it is the reference after which design of the Spectra Optia CMNC collection procedure was modeled.</description>
          </group>
        </group_list>
        <measure>
          <title>MNC Product Contamination/Purity (%) - Platelet Collection Efficiency (CE1 %)</title>
          <description>Comparison of collection efficiencies associated with the CMNC Collection Procedures on the Spectra Optia and COBE Spectra Apheresis Systems for platelets. CE1 is a measurement of device performance calculated using donor and blood product blood counts collected immediately before and after the collection procedure. The collection efficiency for a given cell type is defined as the percent of processed cells of that cell type that are in fact collected.</description>
          <population>One subject was not included in MNC CE1 because of missing MNC lab results post-collection, therefore CE1 could not be calculated.</population>
          <units>percent</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="11"/>
                <count group_id="O2" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Spectra Optia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="28.7" spread="14.08"/>
                    <measurement group_id="O2" value="23.5" spread="8.62"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>COBE Spectra</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="27.9" spread="9.19"/>
                    <measurement group_id="O2" value="30.3" spread="9.85"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>MNC Blood Product Volume (mL)</title>
        <description>The produced unit of MNCs collected into the blood bag.</description>
        <time_frame>within 5 minutes upon completion of procedure</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Treatment Assignment 1</title>
            <description>Spectra Optia CMNC collection procedure followed by COBE Spectra MNC collection procedure.&#xD;
Spectra Optia CMNC: The Spectra Optia® Apheresis System is an automated centrifugal system that separates whole blood into its cellular and plasma components. The device is comprised of three major sub-systems, 1) the apheresis machine itself (centrifuge, centrifuge filler, pumps, valves, computerized safety and control systems, etc.), 2) a sterile, single-use, disposable blood tubing set, and 3) embedded software. The Spectra Optia system's investigational CMNC procedure will be used to collect MNC from the peripheral blood.&#xD;
COBE Spectra MNC: It is also a centrifugal system that separates whole blood into its cellular and plasma components. The COBE Spectra MNC collection procedure is chosen as the comparator device because it is the reference after which design of the Spectra Optia CMNC collection procedure was modeled.</description>
          </group>
          <group group_id="O2">
            <title>Treatment Assignment 2</title>
            <description>COBE Spectra MNC collection procedure followed by Spectra Optia CMNC collection procedure.&#xD;
Spectra Optia CMNC: The Spectra Optia® Apheresis System is an automated centrifugal system that separates whole blood into its cellular and plasma components. The device is comprised of three major sub-systems, 1) the apheresis machine itself (centrifuge, centrifuge filler, pumps, valves, computerized safety and control systems, etc.), 2) a sterile, single-use, disposable blood tubing set, and 3) embedded software. The Spectra Optia system's investigational CMNC procedure will be used to collect MNC from the peripheral blood.&#xD;
COBE Spectra MNC: It is also a centrifugal system that separates whole blood into its cellular and plasma components. The COBE Spectra MNC collection procedure is chosen as the comparator device because it is the reference after which design of the Spectra Optia CMNC collection procedure was modeled.</description>
          </group>
        </group_list>
        <measure>
          <title>MNC Blood Product Volume (mL)</title>
          <description>The produced unit of MNCs collected into the blood bag.</description>
          <units>mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Spectra Optia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="144.8" spread="32.99"/>
                    <measurement group_id="O2" value="141.3" spread="30.82"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>COBE Spectra</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="140.8" spread="28.36"/>
                    <measurement group_id="O2" value="137.7" spread="28.64"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Purity of Plasma Collected for Laboratory Processing of MNC Product - Platelet Concentration in Plasma (10^3/µL)</title>
        <description>A small amount of plasma typically used for processing was collected in a sub-set of collection procedures.</description>
        <time_frame>within 5 minutes upon completion of procedure</time_frame>
        <population>Five collections also collected plasma for this sub-study.</population>
        <group_list>
          <group group_id="O1">
            <title>Treatment Assignment 1</title>
            <description>Spectra Optia CMNC collection procedure followed by COBE Spectra MNC collection procedure.&#xD;
Spectra Optia CMNC: The Spectra Optia® Apheresis System is an automated centrifugal system that separates whole blood into its cellular and plasma components. The device is comprised of three major sub-systems, 1) the apheresis machine itself (centrifuge, centrifuge filler, pumps, valves, computerized safety and control systems, etc.), 2) a sterile, single-use, disposable blood tubing set, and 3) embedded software. The Spectra Optia system's investigational CMNC procedure will be used to collect MNC from the peripheral blood.&#xD;
COBE Spectra MNC: It is also a centrifugal system that separates whole blood into its cellular and plasma components. The COBE Spectra MNC collection procedure is chosen as the comparator device because it is the reference after which design of the Spectra Optia CMNC collection procedure was modeled.</description>
          </group>
          <group group_id="O2">
            <title>Treatment Assignment 2</title>
            <description>COBE Spectra MNC collection procedure followed by Spectra Optia CMNC collection procedure.&#xD;
Spectra Optia CMNC: The Spectra Optia® Apheresis System is an automated centrifugal system that separates whole blood into its cellular and plasma components. The device is comprised of three major sub-systems, 1) the apheresis machine itself (centrifuge, centrifuge filler, pumps, valves, computerized safety and control systems, etc.), 2) a sterile, single-use, disposable blood tubing set, and 3) embedded software. The Spectra Optia system's investigational CMNC procedure will be used to collect MNC from the peripheral blood.&#xD;
COBE Spectra MNC: It is also a centrifugal system that separates whole blood into its cellular and plasma components. The COBE Spectra MNC collection procedure is chosen as the comparator device because it is the reference after which design of the Spectra Optia CMNC collection procedure was modeled.</description>
          </group>
        </group_list>
        <measure>
          <title>Purity of Plasma Collected for Laboratory Processing of MNC Product - Platelet Concentration in Plasma (10^3/µL)</title>
          <description>A small amount of plasma typically used for processing was collected in a sub-set of collection procedures.</description>
          <population>Five collections also collected plasma for this sub-study.</population>
          <units>cells*10^3/µL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2"/>
                <count group_id="O2" value="3"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Spectra Optia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="32.5" spread="30.41"/>
                    <measurement group_id="O2" value="8.7" spread="5.86"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>COBE Spectra</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="147.5" spread="4.95"/>
                    <measurement group_id="O2" value="179.3" spread="72.47"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Procedure Time (Minutes)</title>
        <time_frame>within 5 minutes upon completion of procedure</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Treatment Assignment 1</title>
            <description>Spectra Optia CMNC collection procedure followed by COBE Spectra MNC collection procedure.&#xD;
Spectra Optia CMNC: The Spectra Optia® Apheresis System is an automated centrifugal system that separates whole blood into its cellular and plasma components. The device is comprised of three major sub-systems, 1) the apheresis machine itself (centrifuge, centrifuge filler, pumps, valves, computerized safety and control systems, etc.), 2) a sterile, single-use, disposable blood tubing set, and 3) embedded software. The Spectra Optia system's investigational CMNC procedure will be used to collect MNC from the peripheral blood.&#xD;
COBE Spectra MNC: It is also a centrifugal system that separates whole blood into its cellular and plasma components. The COBE Spectra MNC collection procedure is chosen as the comparator device because it is the reference after which design of the Spectra Optia CMNC collection procedure was modeled.</description>
          </group>
          <group group_id="O2">
            <title>Treatment Assignment 2</title>
            <description>COBE Spectra MNC collection procedure followed by Spectra Optia CMNC collection procedure.&#xD;
Spectra Optia CMNC: The Spectra Optia® Apheresis System is an automated centrifugal system that separates whole blood into its cellular and plasma components. The device is comprised of three major sub-systems, 1) the apheresis machine itself (centrifuge, centrifuge filler, pumps, valves, computerized safety and control systems, etc.), 2) a sterile, single-use, disposable blood tubing set, and 3) embedded software. The Spectra Optia system's investigational CMNC procedure will be used to collect MNC from the peripheral blood.&#xD;
COBE Spectra MNC: It is also a centrifugal system that separates whole blood into its cellular and plasma components. The COBE Spectra MNC collection procedure is chosen as the comparator device because it is the reference after which design of the Spectra Optia CMNC collection procedure was modeled.</description>
          </group>
        </group_list>
        <measure>
          <title>Procedure Time (Minutes)</title>
          <units>minutes</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Spectra Optia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="153.8" spread="30.90"/>
                    <measurement group_id="O2" value="151.4" spread="27.55"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>COBE Spectra</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="151.1" spread="31.92"/>
                    <measurement group_id="O2" value="146.7" spread="27.35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Device Deficiencies</title>
        <description>Any time a device or disposable does not function as described in the Operator's Manual or Package Insert, a Device Deficiency must be reported. This includes those instances wherein Operator Error led to a malfunction/deficiency. A device deficiency is any inadequacy in the identity, quality, durability, reliability, safety or performance of an investigational device, including malfunction, use errors or inadequacy in the information supplied by the manufacturer. Device malfunctions and device incidents should be reported in the same manner.</description>
        <time_frame>24-hours after last collection procedure</time_frame>
        <population>All pivotal subjects (n=22) received both the Spectra Optia and the COBE Spectra per the crossover design. The lead-in subject only received the Spectra Optia. Both lead-in and pivotal subjects are included in any safety analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Spectra Optia</title>
            <description>Subjects who received an CMNC collection using the Spectra Optia</description>
          </group>
          <group group_id="O2">
            <title>COBE Spectra</title>
            <description>Subjects who received an CMNC collection using the COBE Spectra</description>
          </group>
        </group_list>
        <measure>
          <title>Device Deficiencies</title>
          <description>Any time a device or disposable does not function as described in the Operator's Manual or Package Insert, a Device Deficiency must be reported. This includes those instances wherein Operator Error led to a malfunction/deficiency. A device deficiency is any inadequacy in the identity, quality, durability, reliability, safety or performance of an investigational device, including malfunction, use errors or inadequacy in the information supplied by the manufacturer. Device malfunctions and device incidents should be reported in the same manner.</description>
          <population>All pivotal subjects (n=22) received both the Spectra Optia and the COBE Spectra per the crossover design. The lead-in subject only received the Spectra Optia. Both lead-in and pivotal subjects are included in any safety analysis.</population>
          <units>events</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="23"/>
                <count group_id="O2" value="22"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Post-collection Platelet Loss in Subject</title>
        <description>The percent change from pre-collection platelet count to post-collection subject platelet count.</description>
        <time_frame>24-hours after last collection procedure</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Treatment Assignment 1</title>
            <description>Spectra Optia CMNC collection procedure followed by COBE Spectra MNC collection procedure.&#xD;
Spectra Optia CMNC: The Spectra Optia® Apheresis System is an automated centrifugal system that separates whole blood into its cellular and plasma components. The device is comprised of three major sub-systems, 1) the apheresis machine itself (centrifuge, centrifuge filler, pumps, valves, computerized safety and control systems, etc.), 2) a sterile, single-use, disposable blood tubing set, and 3) embedded software. The Spectra Optia system's investigational CMNC procedure will be used to collect MNC from the peripheral blood.&#xD;
COBE Spectra MNC: It is also a centrifugal system that separates whole blood into its cellular and plasma components. The COBE Spectra MNC collection procedure is chosen as the comparator device because it is the reference after which design of the Spectra Optia CMNC collection procedure was modeled.</description>
          </group>
          <group group_id="O2">
            <title>Treatment Assignment 2</title>
            <description>COBE Spectra MNC collection procedure followed by Spectra Optia CMNC collection procedure.&#xD;
Spectra Optia CMNC: The Spectra Optia® Apheresis System is an automated centrifugal system that separates whole blood into its cellular and plasma components. The device is comprised of three major sub-systems, 1) the apheresis machine itself (centrifuge, centrifuge filler, pumps, valves, computerized safety and control systems, etc.), 2) a sterile, single-use, disposable blood tubing set, and 3) embedded software. The Spectra Optia system's investigational CMNC procedure will be used to collect MNC from the peripheral blood.&#xD;
COBE Spectra MNC: It is also a centrifugal system that separates whole blood into its cellular and plasma components. The COBE Spectra MNC collection procedure is chosen as the comparator device because it is the reference after which design of the Spectra Optia CMNC collection procedure was modeled.</description>
          </group>
        </group_list>
        <measure>
          <title>Post-collection Platelet Loss in Subject</title>
          <description>The percent change from pre-collection platelet count to post-collection subject platelet count.</description>
          <units>percent change</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Spectra Optia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="27.2" spread="9.88"/>
                    <measurement group_id="O2" value="23.9" spread="8.04"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>COBE Spectra</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="27.2" spread="9.42"/>
                    <measurement group_id="O2" value="30.7" spread="6.18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>MNC Collection Efficiency (CE2%)</title>
        <description>Comparison of collection efficiencies associated with the CMNC Collection Procedures on the Spectra Optia and COBE Spectra Apheresis Systems for MNCs. CE2 is a measurement of device performance calculated using donor blood counts immediately before and blood product counts immediately after the collection procedure and does not average the donor pre- and post-collection counts. The collection efficiency for a given cell type is defined as the percent of processed cells of that cell type that are in fact collected.</description>
        <time_frame>within 5 minutes upon completion of procedure</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Treatment Assignment 1</title>
            <description>Spectra Optia CMNC collection procedure followed by COBE Spectra MNC collection procedure.&#xD;
Spectra Optia CMNC: The Spectra Optia® Apheresis System is an automated centrifugal system that separates whole blood into its cellular and plasma components. The device is comprised of three major sub-systems, 1) the apheresis machine itself (centrifuge, centrifuge filler, pumps, valves, computerized safety and control systems, etc.), 2) a sterile, single-use, disposable blood tubing set, and 3) embedded software. The Spectra Optia system's investigational CMNC procedure will be used to collect MNC from the peripheral blood.&#xD;
COBE Spectra MNC: It is also a centrifugal system that separates whole blood into its cellular and plasma components. The COBE Spectra MNC collection procedure is chosen as the comparator device because it is the reference after which design of the Spectra Optia CMNC collection procedure was modeled.</description>
          </group>
          <group group_id="O2">
            <title>Treatment Assignment 2</title>
            <description>COBE Spectra MNC collection procedure followed by Spectra Optia CMNC collection procedure.&#xD;
Spectra Optia CMNC: The Spectra Optia® Apheresis System is an automated centrifugal system that separates whole blood into its cellular and plasma components. The device is comprised of three major sub-systems, 1) the apheresis machine itself (centrifuge, centrifuge filler, pumps, valves, computerized safety and control systems, etc.), 2) a sterile, single-use, disposable blood tubing set, and 3) embedded software. The Spectra Optia system's investigational CMNC procedure will be used to collect MNC from the peripheral blood.&#xD;
COBE Spectra MNC: It is also a centrifugal system that separates whole blood into its cellular and plasma components. The COBE Spectra MNC collection procedure is chosen as the comparator device because it is the reference after which design of the Spectra Optia CMNC collection procedure was modeled.</description>
          </group>
        </group_list>
        <measure>
          <title>MNC Collection Efficiency (CE2%)</title>
          <description>Comparison of collection efficiencies associated with the CMNC Collection Procedures on the Spectra Optia and COBE Spectra Apheresis Systems for MNCs. CE2 is a measurement of device performance calculated using donor blood counts immediately before and blood product counts immediately after the collection procedure and does not average the donor pre- and post-collection counts. The collection efficiency for a given cell type is defined as the percent of processed cells of that cell type that are in fact collected.</description>
          <units>percent</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Spectra Optia CE2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="50.99" spread="16.590"/>
                    <measurement group_id="O2" value="52.98" spread="17.528"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>COBE Spectra CE2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="37.77" spread="5.297"/>
                    <measurement group_id="O2" value="39.72" spread="13.972"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>MNC Product Contamination/Purity - RBC Concentration (10^6/µL)</title>
        <time_frame>within 5 minutes upon completion of procedure</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Treatment Assignment 1</title>
            <description>Spectra Optia CMNC collection procedure followed by COBE Spectra MNC collection procedure.&#xD;
Spectra Optia CMNC: The Spectra Optia® Apheresis System is an automated centrifugal system that separates whole blood into its cellular and plasma components. The device is comprised of three major sub-systems, 1) the apheresis machine itself (centrifuge, centrifuge filler, pumps, valves, computerized safety and control systems, etc.), 2) a sterile, single-use, disposable blood tubing set, and 3) embedded software. The Spectra Optia system's investigational CMNC procedure will be used to collect MNC from the peripheral blood.&#xD;
COBE Spectra MNC: It is also a centrifugal system that separates whole blood into its cellular and plasma components. The COBE Spectra MNC collection procedure is chosen as the comparator device because it is the reference after which design of the Spectra Optia CMNC collection procedure was modeled.</description>
          </group>
          <group group_id="O2">
            <title>Treatment Assignment 2</title>
            <description>COBE Spectra MNC collection procedure followed by Spectra Optia CMNC collection procedure.&#xD;
Spectra Optia CMNC: The Spectra Optia® Apheresis System is an automated centrifugal system that separates whole blood into its cellular and plasma components. The device is comprised of three major sub-systems, 1) the apheresis machine itself (centrifuge, centrifuge filler, pumps, valves, computerized safety and control systems, etc.), 2) a sterile, single-use, disposable blood tubing set, and 3) embedded software. The Spectra Optia system's investigational CMNC procedure will be used to collect MNC from the peripheral blood.&#xD;
COBE Spectra MNC: It is also a centrifugal system that separates whole blood into its cellular and plasma components. The COBE Spectra MNC collection procedure is chosen as the comparator device because it is the reference after which design of the Spectra Optia CMNC collection procedure was modeled.</description>
          </group>
        </group_list>
        <measure>
          <title>MNC Product Contamination/Purity - RBC Concentration (10^6/µL)</title>
          <units>RBC*10^6/µL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Spectra Optia RBC Concentration</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.029" spread="0.4740"/>
                    <measurement group_id="O2" value="0.526" spread="0.1990"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>COBE Spectra RBC Concentration</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.653" spread="0.2786"/>
                    <measurement group_id="O2" value="0.857" spread="0.2501"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>AEs were captured per protocol from the first dose of G-CSF until final follow up, which was typically 1 day after the last CMNC Collection Procedure for a total of 7 days.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Pre-collection</title>
          <description>Subjects screened and received G-CSF.</description>
        </group>
        <group group_id="E2">
          <title>Spectra Optia</title>
          <description>Subject who received Spectra Optia CMNC collection procedure.</description>
        </group>
        <group group_id="E3">
          <title>COBE Spectra</title>
          <description>Subjects who received COBE Spectra MNC collection procedure.</description>
        </group>
        <group group_id="E4">
          <title>Follow up</title>
          <description>Subjects who completed cross-over design and were followed for at least 1 day.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="23"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>MedDRA (17.1)</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="22" subjects_at_risk="23"/>
                <counts group_id="E2" subjects_affected="13" subjects_at_risk="23"/>
                <counts group_id="E3" subjects_affected="16" subjects_at_risk="22"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="23"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>thrombocytopenia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="23"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="22"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="23"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>palpitations</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="23"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>hypoaesthesia oral</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="23"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="23"/>
              </event>
              <event>
                <sub_title>abdominal distension</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="23"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="23"/>
              </event>
              <event>
                <sub_title>abdominal pain lower</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="23"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="23"/>
              </event>
              <event>
                <sub_title>nausea</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="23"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="23"/>
              </event>
              <event>
                <sub_title>vomiting</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="23"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="23"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>fatigue</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="23"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="23"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="23"/>
              </event>
              <event>
                <sub_title>infusion site extravasation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="23"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="23"/>
              </event>
              <event>
                <sub_title>injection site pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="23"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="23"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>hemoglobin decreased</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="23"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="23"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="22"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="23"/>
              </event>
              <event>
                <sub_title>platelet count decreased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="22"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="23"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>decreased appetite</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="23"/>
              </event>
              <event>
                <sub_title>musculoskeletal pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="23"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="23"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>back pain</sub_title>
                <counts group_id="E1" subjects_affected="10" subjects_at_risk="23"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="23"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="23"/>
              </event>
              <event>
                <sub_title>bone pain</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="23"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="23"/>
              </event>
              <event>
                <sub_title>muscle spasm</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="23"/>
              </event>
              <event>
                <sub_title>arthralgia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="23"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="23"/>
              </event>
              <event>
                <sub_title>musculoskeletal stiffness</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="23"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="23"/>
              </event>
              <event>
                <sub_title>pain in extremity</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="23"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="23"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>paraesthesia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="23"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="23"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="22"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="23"/>
              </event>
              <event>
                <sub_title>headache</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="23"/>
              </event>
              <event>
                <sub_title>neuropathy peripheral</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="23"/>
              </event>
              <event>
                <sub_title>peripheral sensory neuropathy</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="23"/>
              </event>
              <event>
                <sub_title>tension headach</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="23"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="23"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>insomina</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="23"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="23"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="23"/>
              </event>
              <event>
                <sub_title>restlessness</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="23"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="23"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Raymond P. Goodrich, PhD, VP, Scientific and Clinical Affairs; Chief Science Officer - BBT</name_or_title>
      <organization>Terumo BCT</organization>
      <phone>303-232-6800</phone>
      <email>Ray.Goodrich@terumobct.com</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02253160
org study id: CTS-5038
nct id: NCT02253160
lead sponsor: 
has dmc: No
The purpose of this prospective, randomized, cross-over, multi-center study is to evaluate
      the performance of the Spectra Optia Apheresis System's CMNC Collection Procedure, compared
      to the COBE Spectra Apheresis System's MNC Procedure in mobilized healthy donors. Subject
      safety will be evaluated beginning with mobilization, throughout the collection procedure and
      for the day following the last collection.
This is a prospective, randomized, cross-over, multi-center study to evaluate the performance
      of the Spectra Optia system's CMNC Collection Procedure, compared to the COBE Spectra
      system's MNC Procedure in mobilized healthy donors.

      Up to 60 subject may be consented to meet the the enrollment target of 20 complete subjects.
      Eligible subjects will be randomized to receive either the Spectra Optia CMNC or the COBE
      Spectra MNC collection procedure first, followed by the opposite on the following day.

      Study participation will be up to 14 days: a 7-day screening period, four days for
      mobilization, one day for the first MNC collection with additional dose of mobilization, one
      day for the second MNC collection, and safety follow-up the following day.

      Subject safety will be evaluated beginning with mobilization, throughout the collection
      procedure and for the day following the second collection.
allocation: Randomized
intervention model: Crossover Assignment
masking: None (Open Label)
measure: CD34+ Collection Efficiency (CE1 %)
time frame: within 5 minutes upon completion of procedure
description: The primary endpoint is the CD34+ cell collection efficiency (CE) associated with the Mononuclear Cell (CMNC) Collection Procedures on the Spectra Optia and COBE Spectra Apheresis Systems. CE is a measurement of device performance calculated using donor and blood product blood counts collected immediately before and after the CMNC collection procedure. The collection efficiency for a given cell type is defined as the percent of processed cells of that cell type that are in fact collected.
measure: CD34+ Collection Efficiency (CE2 %)
time frame: within 5 minutes upon completion of procedure
description: Comparison of collection efficiencies associated with the CMNC Cell Collection Procedures on the Spectra Optia and COBE Spectra Apheresis Systems. CE is a measurement of device performance calculated using donor blood counts immediately before and blood product blood counts immediately after the collection procedure. The collection efficiency for a given cell type is defined as the percent of processed cells of that cell type that are in fact collected.
measure: MNC Collection Efficiency (CE1%)
time frame: within 5 minutes upon completion of procedure
description: Comparison of collection efficiencies associated with the CMNC Collection Procedures on the Spectra Optia and COBE Spectra Apheresis Systems for MNCs. CE1 is a measurement of device performance calculated using donor and blood product blood counts collected immediately before and after the collection procedure. The collection efficiency for a given cell type is defined as the percent of processed cells of that cell type that are in fact collected.
measure: CD34+ Per kg of Body Weight
time frame: within 5 minutes upon completion of procedure
measure: MNC Product Contamination/Purity (%) - Hematocrit (%)
time frame: within 5 minutes upon completion of procedure
measure: MNC Product Contamination/Purity (%) - Granulocyte Concentration (10^3/mL)
time frame: within 5 minutes upon completion of procedure
measure: MNC Product Contamination/Purity (%) - Platelet Concentration (10^3/µL)
time frame: within 5 minutes upon completion of procedure
measure: MNC Product Contamination/Purity (%) - Platelet Collection Efficiency (CE1 %)
time frame: within 5 minutes upon completion of procedure
description: Comparison of collection efficiencies associated with the CMNC Collection Procedures on the Spectra Optia and COBE Spectra Apheresis Systems for platelets. CE1 is a measurement of device performance calculated using donor and blood product blood counts collected immediately before and after the collection procedure. The collection efficiency for a given cell type is defined as the percent of processed cells of that cell type that are in fact collected.
measure: MNC Blood Product Volume (mL)
time frame: within 5 minutes upon completion of procedure
description: The produced unit of MNCs collected into the blood bag.
measure: Purity of Plasma Collected for Laboratory Processing of MNC Product - Platelet Concentration in Plasma (10^3/µL)
time frame: within 5 minutes upon completion of procedure
description: A small amount of plasma typically used for processing was collected in a sub-set of collection procedures.
measure: Procedure Time (Minutes)
time frame: within 5 minutes upon completion of procedure
measure: MNC Collection Efficiency (CE2%)
time frame: within 5 minutes upon completion of procedure
description: Comparison of collection efficiencies associated with the CMNC Collection Procedures on the Spectra Optia and COBE Spectra Apheresis Systems for MNCs. CE2 is a measurement of device performance calculated using donor blood counts immediately before and blood product counts immediately after the collection procedure and does not average the donor pre- and post-collection counts. The collection efficiency for a given cell type is defined as the percent of processed cells of that cell type that are in fact collected.
measure: MNC Product Contamination/Purity - RBC Concentration (10^6/µL)
time frame: within 5 minutes upon completion of procedure
measure: Device Deficiencies
time frame: 24-hours after last collection procedure
description: Any time a device or disposable does not function as described in the Operator's Manual or Package Insert, a Device Deficiency must be reported. This includes those instances wherein Operator Error led to a malfunction/deficiency. A device deficiency is any inadequacy in the identity, quality, durability, reliability, safety or performance of an investigational device, including malfunction, use errors or inadequacy in the information supplied by the manufacturer. Device malfunctions and device incidents should be reported in the same manner.
measure: Post-collection Platelet Loss in Subject
time frame: 24-hours after last collection procedure
description: The percent change from pre-collection platelet count to post-collection subject platelet count.
arm group label: Spectra Optia CMNC first, then COBE Spectra MNC
arm group type: Experimental
description: Spectra Optia CMNC collection procedure followed by COBE Spectra MNC collection procedure.
arm group label: COBE Spectra MNC first, then Spectra Optia CMNC
arm group type: Experimental
description: COBE Spectra MNC collection procedure followed by Spectra Optia CMNC collection procedure.
intervention type: Device
intervention name: Spectra Optia CMNC
description: The Spectra Optia® Apheresis System is an automated centrifugal system that separates whole blood into its cellular and plasma components. The device is comprised of three major sub-systems, 1) the apheresis machine itself (centrifuge, centrifuge filler, pumps, valves, computerized safety and control systems, etc.), 2) a sterile, single-use, disposable blood tubing set, and 3) embedded software. The Spectra Optia system's investigational CMNC procedure will be used to collect MNC from the peripheral blood.
arm group label: COBE Spectra MNC first, then Spectra Optia CMNC
arm group label: Spectra Optia CMNC first, then COBE Spectra MNC
other name: Spectra Optia Apheresis System CMNC collection procedure
intervention type: Device
intervention name: COBE Spectra MNC
description: It is also a centrifugal system that separates whole blood into its cellular and plasma components. The COBE Spectra MNC collection procedure is chosen as the comparator device because it is the reference after which design of the Spectra Optia CMNC collection procedure was modeled.
arm group label: COBE Spectra MNC first, then Spectra Optia CMNC
arm group label: Spectra Optia CMNC first, then COBE Spectra MNC
other name: COBE Spectra Apheresis System MNC collection procedure
intervention type: Drug
intervention name: Granulocyte-colony stimulating factor (G-CSF)
description: Each subject received an injection of the G-CSF approximately equivalent to 10 ug/kg body weight subcutaneous per day for 5 days prior to the MNC collection procedure.
arm group label: COBE Spectra MNC first, then Spectra Optia CMNC
arm group label: Spectra Optia CMNC first, then COBE Spectra MNC
other name: Mobilization Procedure
criteria: 
gender: All
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Raymond Goodrich, PhD
role: Study Director
affiliation: Terumo BCT
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Lenograstim
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 