<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/NCT03271229</url>
  </required_header>
  <id_info>
    <org_study_id>15-008718</org_study_id>
    <nct_id>NCT03271229</nct_id>
  </id_info>
  <brief_title>Conventional Platelet-Rich Plasma Versus Concentrated Bone Marrow Stem Cell Injections for Osteoarthritis of the Knee</brief_title>
  <official_title>A Randomized, Single-Blinded, Controlled Trial Comparing Conventional Platelet Rich Plasma (PRP) to Concentrated Bone Marrow Aspirate (BMAC) for Osteoarthritis of the Knee</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mayo Clinic</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mayo Clinic</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Previous clinical trials have demonstrated the human body's own healing and regenerative&#xD;
      cells can relieve the pain of arthritis. Bone marrow contains stem cells which can change&#xD;
      into cells of various different tissue types, while platelet rich plasma contains growth&#xD;
      factors. Both techniques have been shown to relieve pain and with this study the&#xD;
      Investigators wish to compare the two treatments.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Participants will be randomized into two groups. Concentrated Bone Marrow Aspirate (BMAC) or&#xD;
      Platelet-Rich Plasma (PRP). BMAC subjects will have bone marrow aspirated from the subjects&#xD;
      iliac crests and the cellular rich portion will be concentrated and subsequently injected&#xD;
      into the subjects' symptomatic knee. BMAC patients will also have a venous whole blood drawn&#xD;
      from the antecubital vein to simulate a PRP procedure. PRP subjects will have the same venous&#xD;
      blood draw from the antecubital vein with subsequent platelet concentration. The resulting&#xD;
      PRP will be injected into the symptomatic knee. PRP subjects will also undergo a bone marrow&#xD;
      aspiration from the iliac crest to simulate the BMAC procedure. Follow-up at 1 week, 6 weeks,&#xD;
      6 months, and 12 months after injection, with repeat radiographs at 12 months.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Funding&#xD;
  </why_stopped>
  <start_date type="Anticipated">September 2019</start_date>
  <completion_date type="Anticipated">January 2021</completion_date>
  <primary_completion_date type="Anticipated">January 2021</primary_completion_date>
  <phase>Phase 2</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>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Occurrence of Adverse Events</measure>
    <time_frame>approximately 12 months</time_frame>
    <description>The number of adverse events</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Morbidity</measure>
    <time_frame>approximately 12 months</time_frame>
    <description>The number of deceased participants</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Osteo Arthritis Knee</condition>
  <arm_group>
    <arm_group_label>Stem Cells</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants will have Concentrated Bone Marrow Aspirate (BMAC) injections into symptomatic knee</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Plasma</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants will have Platelet-Rich Plasma (PRP) injections into symptomatic knee</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Concentrated Bone Marrow Aspirate (BMAC)</intervention_name>
    <description>Participants will have a knee injected with BMAC stem cells harvested from the iliac crest</description>
    <arm_group_label>Stem Cells</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Platelet-Rich Plasma (PRP)</intervention_name>
    <description>Participants will have a knee injected with Platelet-Rich Plasma (PRP) obtained from a venous whole blood draw from the antecubital vein.</description>
    <arm_group_label>Plasma</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subjects must have bilateral OA and pain in one knee.&#xD;
&#xD;
          -  Osteoarthritis may be primary or secondary. Knees must have Kellgren-Lawrence Grades&#xD;
             1-3.&#xD;
&#xD;
          -  Subjects must have previously tried 6 weeks of one of the following conservative&#xD;
             treatments: Activity modification, weight loss, physical therapy, anti-inflammatory,&#xD;
             or injection therapy.&#xD;
&#xD;
          -  Patients must be able to provide written informed consent after the nature of the&#xD;
             study is fully explained.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with abnormal hematology, serum chemistry, or screening laboratory results.&#xD;
&#xD;
          -  Patients taking anti-inflammatory medications (prescription or over-the-counter),&#xD;
             including herbal therapies, within 14 days of baseline visit.&#xD;
&#xD;
          -  Patients taking anti-rheumatic disease medication (including methotrexate or other&#xD;
             antimetabolites) within the 3 months prior to study entry.&#xD;
&#xD;
          -  Patients receiving injections to the treated knee within 3 months prior to study&#xD;
             entry.&#xD;
&#xD;
          -  Patients who are pregnant or currently breast-feeding.&#xD;
&#xD;
          -  Patients with systemic, rheumatic, or inflammatory disease of the knee or&#xD;
             chondrocalcinosis, hemochromatosis, inflammatory arthritis, arthropathy of the knee&#xD;
             associated with juxta-articular Paget's disease of the femur or tibia, ochronosis,&#xD;
             hemophilic arthropathy, infectious arthritis, Charcot's knee joint, villonodular&#xD;
             synovitis, and synovial chondromatosis.&#xD;
&#xD;
          -  Patients with ongoing known infectious disease.&#xD;
&#xD;
          -  Patients with clinically significant cardiovascular, renal, hepatic, endocrine&#xD;
             disease, or cancer.&#xD;
&#xD;
          -  Patients participating in a study of an experimental drug or medical device within 30&#xD;
             days of study entry.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Shane A Shapiro</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mayo Clinic</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Mayo Clinic in Florida</name>
      <address>
        <city>Jacksonville</city>
        <state>Florida</state>
        <zip>32224</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://www.mayo.edu/research/clinical-trials</url>
    <description>Mayo Clinic Clinical Trials</description>
  </link>
  <verification_date>December 2019</verification_date>
  <study_first_submitted>August 31, 2017</study_first_submitted>
  <study_first_submitted_qc>August 31, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 5, 2017</study_first_posted>
  <last_update_submitted>December 22, 2019</last_update_submitted>
  <last_update_submitted_qc>December 22, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">December 24, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Mayo Clinic</investigator_affiliation>
    <investigator_full_name>Shane A. Shapiro</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Platelet rich plasma</keyword>
  <keyword>bone marrow</keyword>
  <keyword>stem cell</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Osteoarthritis</mesh_term>
    <mesh_term>Osteoarthritis, Knee</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03271229
org study id: 15-008718
nct id: NCT03271229
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
Previous clinical trials have demonstrated the human body's own healing and regenerative
      cells can relieve the pain of arthritis. Bone marrow contains stem cells which can change
      into cells of various different tissue types, while platelet rich plasma contains growth
      factors. Both techniques have been shown to relieve pain and with this study the
      Investigators wish to compare the two treatments.
Participants will be randomized into two groups. Concentrated Bone Marrow Aspirate (BMAC) or
      Platelet-Rich Plasma (PRP). BMAC subjects will have bone marrow aspirated from the subjects
      iliac crests and the cellular rich portion will be concentrated and subsequently injected
      into the subjects' symptomatic knee. BMAC patients will also have a venous whole blood drawn
      from the antecubital vein to simulate a PRP procedure. PRP subjects will have the same venous
      blood draw from the antecubital vein with subsequent platelet concentration. The resulting
      PRP will be injected into the symptomatic knee. PRP subjects will also undergo a bone marrow
      aspiration from the iliac crest to simulate the BMAC procedure. Follow-up at 1 week, 6 weeks,
      6 months, and 12 months after injection, with repeat radiographs at 12 months.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Occurrence of Adverse Events
time frame: approximately 12 months
description: The number of adverse events
measure: Morbidity
time frame: approximately 12 months
description: The number of deceased participants
arm group label: Stem Cells
arm group type: Active Comparator
description: Participants will have Concentrated Bone Marrow Aspirate (BMAC) injections into symptomatic knee
arm group label: Plasma
arm group type: Active Comparator
description: Participants will have Platelet-Rich Plasma (PRP) injections into symptomatic knee
intervention type: Biological
intervention name: Concentrated Bone Marrow Aspirate (BMAC)
description: Participants will have a knee injected with BMAC stem cells harvested from the iliac crest
arm group label: Stem Cells
intervention type: Biological
intervention name: Platelet-Rich Plasma (PRP)
description: Participants will have a knee injected with Platelet-Rich Plasma (PRP) obtained from a venous whole blood draw from the antecubital vein.
arm group label: Plasma
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Shane A Shapiro
role: Principal Investigator
affiliation: Mayo Clinic
facility: 
country: United States
url: https://www.mayo.edu/research/clinical-trials
description: Mayo Clinic Clinical Trials
responsible party type: Principal Investigator
investigator affiliation: Mayo Clinic
investigator full name: Shane A. Shapiro
investigator title: Principal Investigator
mesh term: Osteoarthritis
mesh term: Osteoarthritis, Knee
sharing ipd: No