<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/NCT03014037</url>
  </required_header>
  <id_info>
    <org_study_id>IRB00093044</org_study_id>
    <nct_id>NCT03014037</nct_id>
  </id_info>
  <brief_title>Comparing Mesenchymal Stem Cell Counts in Unilateral vs. Bilateral Posterior Superior Iliac Spine Bone Marrow Aspiration</brief_title>
  <official_title>Comparing Mesenchymal Stem Cell Counts in Unilateral vs. Bilateral Posterior Superior Iliac Spine Bone Marrow Aspiration</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Emory University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Emory University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Musculoskeletal conditions are common sources of pain. Specifically, osteoarthritis affects&#xD;
      nearly 27 million people in the United States. This disease leads to the breakdown of the&#xD;
      cartilage surfaces of the joints, which serve as the connection points between the bones of&#xD;
      the body, causing a large amount of pain and disability in patients. Increasing the number of&#xD;
      available treatment options for osteoarthritis is becoming increasingly more important as&#xD;
      Americans continue to age. Using stem cells taken from bone marrow is one of the&#xD;
      non-operative treatments that has been gaining popularity in the recent past. This study aims&#xD;
      to clarify how this procedure should best be done by comparing stem cell concentrations and&#xD;
      patient outcomes (short and long term) in patients who have stem cells taken from one area vs&#xD;
      two (unilateral vs bilateral posterior superior iliac spine (PSIS) aspirations).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Musculoskeletal conditions are common sources of pain. Specifically, osteoarthritis affects&#xD;
      nearly 27 million people in the United States. This disease leads to the breakdown of the&#xD;
      cartilage surfaces of the joints, which serve as the connection points between the bones of&#xD;
      the body, causing a large amount of pain and disability in patients. Increasing the number of&#xD;
      available treatment options for osteoarthritis is becoming increasingly more important as&#xD;
      Americans continue to age. Using stem cells taken from bone marrow is one of the&#xD;
      non-operative treatments that has been gaining popularity in the recent past. This study aims&#xD;
      to clarify how this procedure should best be done by comparing stem cell concentrations and&#xD;
      patient outcomes (short and long term) in patients who have stem cells taken from one area vs&#xD;
      two (unilateral vs bilateral posterior superior iliac spine (PSIS) aspirations).&#xD;
&#xD;
      This research study involves the participant being randomly placed into one of two groups;&#xD;
      one group will have cells taken from one hip, and the other will have cells taken from both&#xD;
      hips. Both of these approaches are performed in clinics currently, and both are considered to&#xD;
      be standard of care. All bone marrow collected for the purposes of this study will be&#xD;
      obtained by the principal investigator while performing the standard procedure. In obtaining&#xD;
      these sample the physicians will abide by the standard of care set forth for the Bone Marrow&#xD;
      Aspiration Concentrate procedure.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 7, 2017</start_date>
  <completion_date type="Actual">June 13, 2020</completion_date>
  <primary_completion_date type="Actual">June 13, 2020</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>Parallel Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change Quality of Life assessed by the Emory Quality of Life (EQOL) Survey Score</measure>
    <time_frame>Pre-treatment, Follow Up (Up to One Year)</time_frame>
    <description>The EQOL survey measures five dimensions - mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The participant will be asked to answer questions regarding these measures and to indicate their current experience on a scale from 1 to 3; 1 being &quot;no problem&quot; and 3 being &quot;most extreme problem&quot;. The answers to these question are put together to create a 5 digit composite score.This composite score can be indexed to a lookup table which produces a single summary score from 0 to 100. The lookup table we use is weighted and normalized to the United Stated general population.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in the Knee Injury and Osteoarthritis Outcome Score (KOOS)</measure>
    <time_frame>Pre-treatment, Follow Up (Up to One Year)</time_frame>
    <description>The KOOS questionnaire is an instrument to assess the patient's opinion about their osteoarthritis and associated problems. It consists of 5 subscales; Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport/Rec) and knee related Quality of life (QOL). Standardized answer options are given (5 Likert boxes) and each question is assigned a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale. A total lower score indicates more problems.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Capacity of Isolated Cells to Differentiate Down Cell Lineages</measure>
    <time_frame>Post Cell Culture (Up to 21 Days)</time_frame>
    <description>Bone marrow aspirate will be placed in 10 mL heparinized tubes and nucleated cells will be isolated with a density gradient and re-suspended in complete culture medium for plating. Isolated adherent cells will be processed for the ability to differentiate down osteogenic-, adipogenic- and chondrogenic-lineage after cell harvest. Specifically, isolated cells are treated with different media to induce their differentiation into 1) osteo-progenitor cells (identified by positive staining with Alzarian red, 2) adipocytes (identified by positive staining with Oil-Red) and 3) chondrocytes (identified by positive staining with Alcian blue). The presence of these phenotypes should be prevalent by 3 weeks; if not, the cells are not considered pluripotent for that lineage and hence would not be classified as mesenchymal stem cells.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">35</enrollment>
  <condition>Osteoarthritis</condition>
  <arm_group>
    <arm_group_label>Unilateral Procurement of Bone Marrow</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Participants currently scheduled to undergo a bone marrow aspirate concentration (BMAC) procedure will be randomized to unilateral procurement of bone marrow.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Bilateral Bone Marrow Procurement</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants currently scheduled to undergo a bone marrow aspirate concentration (BMAC) procedure will be randomized to bilateral procurement of bone marrow.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Unilateral Bone Marrow Procurement</intervention_name>
    <description>A total of 61cc of bone marrow will be procured under ultrasound guidance from one posterior superior iliac spine (PSIS) via 3 passes, each at least 1 cm apart, through the bone cortex. In each pass, investigators will obtain 2.3cc of BMA with a 60cc syringes.</description>
    <arm_group_label>Unilateral Procurement of Bone Marrow</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Bilateral Bone Marrow Procurement</intervention_name>
    <description>30.5cc of bone marrow will be obtained under ultrasound guidance from each posterior superior iliac spine (PSIS) with 3 passes, at least 1 cm apart, per side (10.17cc per pass) using 60cc syringes. The collection from each PSIS will be combined to yield a total of 61cc.</description>
    <arm_group_label>Bilateral Bone Marrow Procurement</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Currently scheduled for a bone marrow aspirate concentration (BMAC) procedure&#xD;
&#xD;
          -  Cognitively able to give consent and complete the required questionnaires&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of leukemia or lymphoma&#xD;
&#xD;
          -  History of any autoimmune disorders and disease&#xD;
&#xD;
          -  Currently taking immunosuppressive medications&#xD;
&#xD;
          -  Presence of an active or suspected infection, or an infection of the joint in question&#xD;
             within the past 6 months&#xD;
&#xD;
          -  Vulnerable populations (pregnant women and breast-feeding women)&#xD;
&#xD;
          -  Cortisone injection into the affected joint within 6 weeks&#xD;
&#xD;
          -  Used NSAIDs within 1 week of the procedure&#xD;
&#xD;
          -  History of bleeding disorders or inflammatory joint disease&#xD;
&#xD;
          -  Surgical intervention on the affected or contralateral joint within 6 months of BMAC&#xD;
             injection&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kenneth Mautner, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Emory University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The Emory Clinic</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30322</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2021</verification_date>
  <study_first_submitted>January 5, 2017</study_first_submitted>
  <study_first_submitted_qc>January 5, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 9, 2017</study_first_posted>
  <last_update_submitted>December 13, 2021</last_update_submitted>
  <last_update_submitted_qc>December 13, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">December 14, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Emory University</investigator_affiliation>
    <investigator_full_name>Kenneth Mautner</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>Orthopedics</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Osteoarthritis</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/NCT03014037
org study id: IRB00093044
nct id: NCT03014037
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Musculoskeletal conditions are common sources of pain. Specifically, osteoarthritis affects
      nearly 27 million people in the United States. This disease leads to the breakdown of the
      cartilage surfaces of the joints, which serve as the connection points between the bones of
      the body, causing a large amount of pain and disability in patients. Increasing the number of
      available treatment options for osteoarthritis is becoming increasingly more important as
      Americans continue to age. Using stem cells taken from bone marrow is one of the
      non-operative treatments that has been gaining popularity in the recent past. This study aims
      to clarify how this procedure should best be done by comparing stem cell concentrations and
      patient outcomes (short and long term) in patients who have stem cells taken from one area vs
      two (unilateral vs bilateral posterior superior iliac spine (PSIS) aspirations).
Musculoskeletal conditions are common sources of pain. Specifically, osteoarthritis affects
      nearly 27 million people in the United States. This disease leads to the breakdown of the
      cartilage surfaces of the joints, which serve as the connection points between the bones of
      the body, causing a large amount of pain and disability in patients. Increasing the number of
      available treatment options for osteoarthritis is becoming increasingly more important as
      Americans continue to age. Using stem cells taken from bone marrow is one of the
      non-operative treatments that has been gaining popularity in the recent past. This study aims
      to clarify how this procedure should best be done by comparing stem cell concentrations and
      patient outcomes (short and long term) in patients who have stem cells taken from one area vs
      two (unilateral vs bilateral posterior superior iliac spine (PSIS) aspirations).

      This research study involves the participant being randomly placed into one of two groups;
      one group will have cells taken from one hip, and the other will have cells taken from both
      hips. Both of these approaches are performed in clinics currently, and both are considered to
      be standard of care. All bone marrow collected for the purposes of this study will be
      obtained by the principal investigator while performing the standard procedure. In obtaining
      these sample the physicians will abide by the standard of care set forth for the Bone Marrow
      Aspiration Concentrate procedure.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: None (Open Label)
measure: Change Quality of Life assessed by the Emory Quality of Life (EQOL) Survey Score
time frame: Pre-treatment, Follow Up (Up to One Year)
description: The EQOL survey measures five dimensions - mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The participant will be asked to answer questions regarding these measures and to indicate their current experience on a scale from 1 to 3; 1 being "no problem" and 3 being "most extreme problem". The answers to these question are put together to create a 5 digit composite score.This composite score can be indexed to a lookup table which produces a single summary score from 0 to 100. The lookup table we use is weighted and normalized to the United Stated general population.
measure: Change in the Knee Injury and Osteoarthritis Outcome Score (KOOS)
time frame: Pre-treatment, Follow Up (Up to One Year)
description: The KOOS questionnaire is an instrument to assess the patient's opinion about their osteoarthritis and associated problems. It consists of 5 subscales; Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport/Rec) and knee related Quality of life (QOL). Standardized answer options are given (5 Likert boxes) and each question is assigned a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale. A total lower score indicates more problems.
measure: Capacity of Isolated Cells to Differentiate Down Cell Lineages
time frame: Post Cell Culture (Up to 21 Days)
description: Bone marrow aspirate will be placed in 10 mL heparinized tubes and nucleated cells will be isolated with a density gradient and re-suspended in complete culture medium for plating. Isolated adherent cells will be processed for the ability to differentiate down osteogenic-, adipogenic- and chondrogenic-lineage after cell harvest. Specifically, isolated cells are treated with different media to induce their differentiation into 1) osteo-progenitor cells (identified by positive staining with Alzarian red, 2) adipocytes (identified by positive staining with Oil-Red) and 3) chondrocytes (identified by positive staining with Alcian blue). The presence of these phenotypes should be prevalent by 3 weeks; if not, the cells are not considered pluripotent for that lineage and hence would not be classified as mesenchymal stem cells.
arm group label: Unilateral Procurement of Bone Marrow
arm group type: Other
description: Participants currently scheduled to undergo a bone marrow aspirate concentration (BMAC) procedure will be randomized to unilateral procurement of bone marrow.
arm group label: Bilateral Bone Marrow Procurement
arm group type: Experimental
description: Participants currently scheduled to undergo a bone marrow aspirate concentration (BMAC) procedure will be randomized to bilateral procurement of bone marrow.
intervention type: Procedure
intervention name: Unilateral Bone Marrow Procurement
description: A total of 61cc of bone marrow will be procured under ultrasound guidance from one posterior superior iliac spine (PSIS) via 3 passes, each at least 1 cm apart, through the bone cortex. In each pass, investigators will obtain 2.3cc of BMA with a 60cc syringes.
arm group label: Unilateral Procurement of Bone Marrow
intervention type: Procedure
intervention name: Bilateral Bone Marrow Procurement
description: 30.5cc of bone marrow will be obtained under ultrasound guidance from each posterior superior iliac spine (PSIS) with 3 passes, at least 1 cm apart, per side (10.17cc per pass) using 60cc syringes. The collection from each PSIS will be combined to yield a total of 61cc.
arm group label: Bilateral Bone Marrow Procurement
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Kenneth Mautner, MD
role: Principal Investigator
affiliation: Emory University
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Emory University
investigator full name: Kenneth Mautner
investigator title: Associate Professor
mesh term: Osteoarthritis