xml: <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/NCT05985785</url>
    </required_header>
    <id_info>
      <org_study_id>21052504</org_study_id>
      <nct_id>NCT05985785</nct_id>
    </id_info>
    <brief_title>Bone Marrow Aspirate Concentrate (BMAC) vs Corticosteroid Injection</brief_title>
    <acronym>BMAC</acronym>
    <official_title>Bone Marrow Aspirate Concentrate vs Corticosteroid Injection for Symptomatic Osteoarthritis (OA) of the Knee: A Randomized Controlled Trial</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>
    <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>
        Prospective single-masked (study participant will be masked), randomized controlled trial to&#xD;
        examine the influence of BMAC on patient-reported outcomes (PROs) in patients with primary&#xD;
        knee osteoarthritis.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The purpose of this study is to examine the influence of BMAC on patient-reported outcomes&#xD;
        (PROs) in patients with primary knee osteoarthritis and compare that to patients receiving&#xD;
        corticosteroid injections with six-month follow-up.&#xD;
  &#xD;
        All patients who sign the consent form will be enrolled in the study and randomized to one of&#xD;
        the two treatment arms. This study will aim to recruit and enroll a total of 100 patients (50&#xD;
        per group). Treatment arms include BMAC injections (ARM1) and corticosteroid injections (ARM&#xD;
        2). Patients in the corticosteroid injection group (ARM 2) will receive a sham incision.&#xD;
        Follow-up will be up to six months (12-months if crossover (ARM 3)).&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">July 19, 2022</start_date>
    <completion_date type="Anticipated">March 31, 2026</completion_date>
    <primary_completion_date type="Anticipated">December 31, 2025</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>
      <intervention_model_description>Treatment arms include BMAC injections (ARM1) and corticosteroid injections (ARM 2). Patients in the corticosteroid injection group (ARM 2) will receive a sham incision. Follow-up will be up to six months (12-months if crossover (ARM 3)).</intervention_model_description>
      <primary_purpose>Other</primary_purpose>
      <masking>Single (Participant)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Visual analogue scale (VAS) for pain</measure>
      <time_frame>Enrollment up to 6 months postoperatively (12 months if crossover from ARM 3 to ARM 1)</time_frame>
      <description>The Visual Analogue Scale (VAS) measures pain intensity. The VAS consists of a 10cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be'). Ask the patient to rate their current level of pain by placing a mark on the line.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Intermittent and Constant Osteoarthritis Pain (ICOAP)</measure>
      <time_frame>Enrollment up to 6 months postoperatively (12 months if crossover from ARM 3 to ARM 1)</time_frame>
      <description>13 items survey that assess two forms of pain reported by people with osteoarthritis: intermittent and constant pain.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Knee Injury and Osteoarthritis Outcome Score (KOOS)</measure>
      <time_frame>Enrollment up to 6 months postoperatively (12 months if crossover from ARM 3 to ARM 1)</time_frame>
      <description>The KOOS evaluates both short-term and long-term consequences of knee injury. It holds 42 items in 5 separately scored subscales; Pain, other Symptoms, Function in daily living (ADL), Function in Sport and Recreation (Sport/Rec), and knee-related Quality of Life (QOL)</description>
    </primary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Anticipated">100</enrollment>
    <condition>Osteoarthritis of the Knee</condition>
    <arm_group>
      <arm_group_label>Autologous (from subject to self) bone marrow aspirate concentrate (BMAC) injections</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Autologous bone marrow aspirate concentrate (BMAC) will be removed from the subject knee body with a needle, processed and concentrated by an FDA-approved centrifuge (separator) system. The concentrated cells will be injected into the subject knee. &quot;Autologous&quot; means that the subject is receiving back their own cells that were collected.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Corticosteroid injection</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Corticosteroid injection group (ARM 2) will receive a sham incision.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Crossover Group</arm_group_label>
      <arm_group_type>Other</arm_group_type>
      <description>Any patient in the corticosteroid injection group that shows no improvement in pain after 24 weeks (12 month follow-up if crossover), per physician discretion, will be allowed crossover to the BMAC injection group (ARM 3).</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Autologous bone marrow aspirate concentrate (BMAC)</intervention_name>
      <description>Bone marrow aspirate concentrate BMAC is a biologically substance harvested from a patient for autologous use. Bone marrow aspirate concentrate (BMAC) has been determined by the FDA to be a minimally manipulated biologic prepared for autologous use and does not require premarket FDA approval for clinical use.</description>
      <arm_group_label>Autologous (from subject to self) bone marrow aspirate concentrate (BMAC) injections</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Corticosteroid injections</intervention_name>
      <description>Current standard of treatment for OA of the knee is corticosteroid injection.</description>
      <arm_group_label>Corticosteroid injection</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Crossover Autologous bone marrow aspirate concentrate (BMAC)</intervention_name>
      <description>Subjects who participate in this study and who are randomized to receive the BMAC may experience decreased pain and increased functionality after the injection compared to those that receive a corticosteroid injection. As such, participants who continue to have pain after a corticosteroid injection will be allowed to crossover to a BMAC injection at 24 weeks or 6 months post-surgery.(ARM 3)</description>
      <arm_group_label>Crossover Group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients between the ages of 18-70&#xD;
  &#xD;
            -  Long standing knee pain from osteoarthritis (KL grade 2-3) despite conventional&#xD;
               treatments such as activity modification, weight loss, physical therapy, analgesics,&#xD;
               nonsteroidal anti-inflammatory drugs, or injection therapy for at least 6 weeks&#xD;
  &#xD;
            -  7-day average pain score of at least 4 on VAS scale&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Systemic diseases (Diabetes, malignancies, infections, etc.)&#xD;
  &#xD;
            -  Post-traumatic arthritis&#xD;
  &#xD;
            -  Patient had intra-articular injection on affected knee in last three months&#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>Jorge Chahla, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Rush University Medical Center Associate Professor and Surgeon</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Carla M. Edwards, PhD</last_name>
      <phone>312-563-5735</phone>
      <email>carla_edwards@rush.edu</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Jorge Chahla, MD</last_name>
      <phone>(312) 432-2818</phone>
      <email>jorge.chahla@rushortho.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Rush University Medical Center</name>
        <address>
          <city>Chicago</city>
          <state>Illinois</state>
          <zip>60612</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Carla M Edwards, PhD</last_name>
        <phone>312-563-5735</phone>
        <email>carla_edwards@rush.edu</email>
      </contact>
      <investigator>
        <last_name>Jorge Chahla, MD, PhD</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>Adam Yanke, MD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 2, 2023</study_first_submitted>
    <study_first_submitted_qc>August 2, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 2, 2023</last_update_submitted>
    <last_update_submitted_qc>August 2, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 14, 2023</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>Osteoarthritis</mesh_term>
      <mesh_term>Osteoarthritis, Knee</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05985785
  org study id: 21052504
  nct id: NCT05985785
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Prospective single-masked (study participant will be masked), randomized controlled trial to
        examine the influence of BMAC on patient-reported outcomes (PROs) in patients with primary
        knee osteoarthritis.
  The purpose of this study is to examine the influence of BMAC on patient-reported outcomes
        (PROs) in patients with primary knee osteoarthritis and compare that to patients receiving
        corticosteroid injections with six-month follow-up.
  
        All patients who sign the consent form will be enrolled in the study and randomized to one of
        the two treatment arms. This study will aim to recruit and enroll a total of 100 patients (50
        per group). Treatment arms include BMAC injections (ARM1) and corticosteroid injections (ARM
        2). Patients in the corticosteroid injection group (ARM 2) will receive a sham incision.
        Follow-up will be up to six months (12-months if crossover (ARM 3)).
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Treatment arms include BMAC injections (ARM1) and corticosteroid injections (ARM 2). Patients in the corticosteroid injection group (ARM 2) will receive a sham incision. Follow-up will be up to six months (12-months if crossover (ARM 3)).
  primary purpose: Other
  masking: Single (Participant)
  measure: Visual analogue scale (VAS) for pain
  time frame: Enrollment up to 6 months postoperatively (12 months if crossover from ARM 3 to ARM 1)
  description: The Visual Analogue Scale (VAS) measures pain intensity. The VAS consists of a 10cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be'). Ask the patient to rate their current level of pain by placing a mark on the line.
  measure: Intermittent and Constant Osteoarthritis Pain (ICOAP)
  time frame: Enrollment up to 6 months postoperatively (12 months if crossover from ARM 3 to ARM 1)
  description: 13 items survey that assess two forms of pain reported by people with osteoarthritis: intermittent and constant pain.
  measure: Knee Injury and Osteoarthritis Outcome Score (KOOS)
  time frame: Enrollment up to 6 months postoperatively (12 months if crossover from ARM 3 to ARM 1)
  description: The KOOS evaluates both short-term and long-term consequences of knee injury. It holds 42 items in 5 separately scored subscales; Pain, other Symptoms, Function in daily living (ADL), Function in Sport and Recreation (Sport/Rec), and knee-related Quality of Life (QOL)
  arm group label: Autologous (from subject to self) bone marrow aspirate concentrate (BMAC) injections
  arm group type: Experimental
  description: Autologous bone marrow aspirate concentrate (BMAC) will be removed from the subject knee body with a needle, processed and concentrated by an FDA-approved centrifuge (separator) system. The concentrated cells will be injected into the subject knee. "Autologous" means that the subject is receiving back their own cells that were collected.
  arm group label: Corticosteroid injection
  arm group type: Active Comparator
  description: Corticosteroid injection group (ARM 2) will receive a sham incision.
  arm group label: Crossover Group
  arm group type: Other
  description: Any patient in the corticosteroid injection group that shows no improvement in pain after 24 weeks (12 month follow-up if crossover), per physician discretion, will be allowed crossover to the BMAC injection group (ARM 3).
  intervention type: Other
  intervention name: Autologous bone marrow aspirate concentrate (BMAC)
  description: Bone marrow aspirate concentrate BMAC is a biologically substance harvested from a patient for autologous use. Bone marrow aspirate concentrate (BMAC) has been determined by the FDA to be a minimally manipulated biologic prepared for autologous use and does not require premarket FDA approval for clinical use.
  arm group label: Autologous (from subject to self) bone marrow aspirate concentrate (BMAC) injections
  intervention type: Drug
  intervention name: Corticosteroid injections
  description: Current standard of treatment for OA of the knee is corticosteroid injection.
  arm group label: Corticosteroid injection
  intervention type: Other
  intervention name: Crossover Autologous bone marrow aspirate concentrate (BMAC)
  description: Subjects who participate in this study and who are randomized to receive the BMAC may experience decreased pain and increased functionality after the injection compared to those that receive a corticosteroid injection. As such, participants who continue to have pain after a corticosteroid injection will be allowed to crossover to a BMAC injection at 24 weeks or 6 months post-surgery.(ARM 3)
  arm group label: Crossover Group
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 70 Years
  healthy volunteers: No
  last name: Jorge Chahla, MD
  role: Principal Investigator
  affiliation: Rush University Medical Center Associate Professor and Surgeon
  last name: Carla M. Edwards, PhD
  phone: 312-563-5735
  email: carla_edwards@rush.edu
  last name: Jorge Chahla, MD
  phone: (312) 432-2818
  email: jorge.chahla@rushortho.com
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  investigator: 
  country: United States
  responsible party type: Sponsor
  mesh term: Osteoarthritis
  mesh term: Osteoarthritis, Knee