<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/NCT02981394</url>
  </required_header>
  <id_info>
    <org_study_id>16090710-IRB01</org_study_id>
    <nct_id>NCT02981394</nct_id>
  </id_info>
  <brief_title>Clinical Outcomes of Autologous Bone Marrow Aspirate Concentrate Injections for Musculoskeletal Conditions</brief_title>
  <official_title>Clinical Outcomes of Autologous Bone Marrow Aspirate Concentrate Injections for Musculoskeletal Conditions</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Rush University Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Rush University Medical Center</source>
  <brief_summary>
    <textblock>
      The use of Bone Marrow Autologous Collection (BMAC) in musculoskeletal conditions including&#xD;
      osteoarthritis and tendon injuries has been growing. Outcome evidence continues to be sparse.&#xD;
      The purpose of this study is collect a longitudinal case series of patient reported outcomes&#xD;
      following BMAC injections for musculoskeletal conditions including osteoarthritis,&#xD;
      tendinopathy and injuries to ligaments, tendons and muscles.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    No active enrollment of patients.&#xD;
  </why_stopped>
  <start_date>November 2016</start_date>
  <completion_date type="Actual">January 2021</completion_date>
  <primary_completion_date type="Anticipated">January 2021</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>5 Years</target_duration>
  <primary_outcome>
    <measure>WOMAC Score</measure>
    <time_frame>5 years</time_frame>
    <description>Pain and Function Score</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">0</enrollment>
  <condition>Musculoskeletal Pain</condition>
  <condition>Osteoarthritis</condition>
  <condition>Tendinopathy</condition>
  <condition>Sprains Strain</condition>
  <arm_group>
    <arm_group_label>BMAC Group</arm_group_label>
    <description>Intervention Group</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Bone Marrow Aspirate Concentrate Injection</intervention_name>
    <description>BMAC will be collected in the outpatient setting with local anesthesia. The collection site will be the Posterior Superior Iliac Spine (PSIS). This will be visualized under ultrasound prior to collection. Local anesthesia with 1% lidocaine will be performed prior to the harvest. BMAC harvest will be performed using the Arthrex Angel BMAC System using the Arthrex collection protocol. The Arthrex Angel machine will be used to separate BMAC contents for injection based on Arthrex collection protocol. Machine settings, volume of collection and volume of output have not been standardized and will be based upon harvest and the condition treated. These will be variables recorded for consideration of optimal settings based on the patient-reported outcomes.</description>
    <arm_group_label>BMAC Group</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with a musculoskeletal condition amenable to BMAC or PRP treatment will be&#xD;
        enrolled upon registration for the selected procedure. Proper counseling regarding the&#xD;
        selected procedure and alternatives will be done prior to enrollment. Patients with&#xD;
        contraindications for the procedure will not undergo the procedure and therefore will not&#xD;
        be enrolled. The study will be non-randomized; therefore, patient selection will be based&#xD;
        upon patient request for the procedure after proper counseling. Counseling regarding cost&#xD;
        of each procedure will also be provided. All costs for the procedure will be the&#xD;
        responsibility of the patient. Proper documentation will also be signed by the patient&#xD;
        indicating that procedure is elective and PRP/BMAC injections will not be billed to their&#xD;
        insurance carriers. Upon enrollment, patients will be consented for the procedure and&#xD;
        longitudinal data collection.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Musculoskeletal Condition that is able to undergo an injection&#xD;
&#xD;
          -  Patient requests the procedure and enrolls with agreement to pay for the procedure&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Active Cancer&#xD;
&#xD;
          -  Allergies to local anesthesia&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Midwest Orthopeadics at Rush</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60612</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2021</verification_date>
  <study_first_submitted>December 1, 2016</study_first_submitted>
  <study_first_submitted_qc>December 1, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 5, 2016</study_first_posted>
  <last_update_submitted>May 25, 2021</last_update_submitted>
  <last_update_submitted_qc>May 25, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">May 27, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tendinopathy</mesh_term>
    <mesh_term>Musculoskeletal Pain</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT02981394
org study id: 16090710-IRB01
nct id: NCT02981394
lead sponsor: 
The use of Bone Marrow Autologous Collection (BMAC) in musculoskeletal conditions including
      osteoarthritis and tendon injuries has been growing. Outcome evidence continues to be sparse.
      The purpose of this study is collect a longitudinal case series of patient reported outcomes
      following BMAC injections for musculoskeletal conditions including osteoarthritis,
      tendinopathy and injuries to ligaments, tendons and muscles.
observational model: Case-Only
time perspective: Prospective
measure: WOMAC Score
time frame: 5 years
description: Pain and Function Score
arm group label: BMAC Group
description: Intervention Group
intervention type: Procedure
intervention name: Bone Marrow Aspirate Concentrate Injection
description: BMAC will be collected in the outpatient setting with local anesthesia. The collection site will be the Posterior Superior Iliac Spine (PSIS). This will be visualized under ultrasound prior to collection. Local anesthesia with 1% lidocaine will be performed prior to the harvest. BMAC harvest will be performed using the Arthrex Angel BMAC System using the Arthrex collection protocol. The Arthrex Angel machine will be used to separate BMAC contents for injection based on Arthrex collection protocol. Machine settings, volume of collection and volume of output have not been standardized and will be based upon harvest and the condition treated. These will be variables recorded for consideration of optimal settings based on the patient-reported outcomes.
arm group label: BMAC Group
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
responsible party type: Sponsor
mesh term: Tendinopathy
mesh term: Musculoskeletal Pain