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/NCT05996224</url>
    </required_header>
    <id_info>
      <org_study_id>CBM-MPC-007</org_study_id>
      <nct_id>NCT05996224</nct_id>
    </id_info>
    <brief_title>Allogenic Adipose-Derived Mesenchymal Progenitor Cells for the Treatment of Knee Osteoarthritis</brief_title>
    <official_title>A Multicenter, Randomized, Double-blind, Controlled Phase III Trial of Allogenic Adipose Tissue-Derived Mesenchymal Progenitor Cells (AlloJoin®) Therapy for Knee Osteoarthritis.</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Cellular Biomedicine Group Ltd.</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Cellular Biomedicine Group Ltd.</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Evaluate the efficacy and safety of Allogenic Adipose Tissue-Derived Mesenchymal Progenitor&#xD;
        Cells Therapy&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        A Multicenter, Randomized, Double-blind, Controlled Phase III Trial of Allogenic Adipose&#xD;
        Tissue-Derived Mesenchymal Progenitor Cells (AlloJoin®) Therapy for Knee Osteoarthritis.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 2023</start_date>
    <completion_date type="Anticipated">December 2027</completion_date>
    <primary_completion_date type="Anticipated">December 2025</primary_completion_date>
    <phase>Phase 3</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>Double (Participant, Investigator)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>WOMAC score</measure>
      <time_frame>24 weeks</time_frame>
      <description>The Western Ontario and McMaster Universities Osteoarthritis Index;0-96 points；96 points mean a worse outcome,will be tested at 24 weeks after the first injection</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>MRI quantitative analysis of articular cartilage</measure>
      <time_frame>48 weeks</time_frame>
      <description>Magnetic Resonance Imaging analysis of articular cartilage, will be tested at 48 weeks after the first injection</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>WOMAC Score</measure>
      <time_frame>4、12、24、36、48、60、72、84、96 weeks</time_frame>
      <description>The Western Ontario and McMaster Universities Osteoarthritis Index;0-96 points；96 points mean a worse outcome, will be tested at 4、12、24、36、48、60、72、84 and 96 weeks after the first injection</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>VAS Score</measure>
      <time_frame>4、12、24、36、48、60、72、84、96 weeks</time_frame>
      <description>Visual Analogue Scale/Score；0-10 points；10 points mean the worse outcome,will be tested at 4、12、24、36、48、60、72、84 and 96 weeks after the first injection</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>SF-36</measure>
      <time_frame>4、12、24、36、48、60、72、84、96 weeks</time_frame>
      <description>The Medical Outcomes Study 36-Item Short-Form Health Survey;0-100 points；100 points mean a better outcome, will be tested at 4、12、24、36、48、60、72、84 and 96 weeks after the first injection</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>MRI quantitative analysis of articular cartilage</measure>
      <time_frame>24 weeks and 96 weeks</time_frame>
      <description>Magnetic Resonance Imaging analysis of articular cartilage, will be tested at 24 and 96 weeks after the first injection</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Whole-Organ Magnetic Resonance Imaging Score</measure>
      <time_frame>24、48 and 96 weeks</time_frame>
      <description>Whole-Organ Magnetic Resonance Imaging Score(WORMS) of the knee; 0-332points; 332 points means the worst outcome; will be assessed at 24、48 and 96 weeks</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>mJSW</measure>
      <time_frame>96 weeks</time_frame>
      <description>Minimum joint space width (mJSW) of the knee, will be measured at baseline and 96 weeks</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Adverse Events and Serious Adverse Events</measure>
      <time_frame>Day 0 to 96 weeks</time_frame>
      <description>AE and SAE, will be assessed within the 96 week time span</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Physical examination</measure>
      <time_frame>Day 0、week 1、2、3、4、12、24、36、48、60、72、84、96</time_frame>
      <description>Height and weight will be tested and combined to report BMI in kg/m^2at Day 0 and week 1、2、3、4、12、24、36、48、60、72、84、96</description>
    </secondary_outcome>
    <other_outcome>
      <measure>Inflammatory biomarkers detection</measure>
      <time_frame>Day 0 and week 4、12、24、36、48、96</time_frame>
      <description>Prostaglandin E2 in serum will be tested at Day 0 and week 4、12、24、36、48、96</description>
    </other_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">488</enrollment>
    <condition>Knee Osteoarthritis</condition>
    <arm_group>
      <arm_group_label>Mesenchymal progenitor cells</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Mesenchymal progenitor cells group</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Sodium hyaluronate</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Sodium hyaluronate injection group</description>
    </arm_group>
    <intervention>
      <intervention_type>Biological</intervention_type>
      <intervention_name>Mesenchymal progenitor cells</intervention_name>
      <description>Allogenic Adipose tissue-derived mesenchymal progenitor cells administrated for intra- articular use</description>
      <arm_group_label>Mesenchymal progenitor cells</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Sodium Hyaluronate Injection</intervention_name>
      <description>Sodium Hyaluronate administrated for intra-articular use</description>
      <arm_group_label>Sodium hyaluronate</arm_group_label>
      <other_name>Hyaluronic acid injection</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Subjects who understand and voluntarily sign the consent form before this study；&#xD;
  &#xD;
            2. According to the diagnostic criteria (American Rheumatology Association, clinical +&#xD;
               radiology criteria), patients with knee osteoarthritis are definitely diagnosed；&#xD;
  &#xD;
            3. Age: 40-75, males and females；&#xD;
  &#xD;
            4. The course of knee osteoarthritis was more than 6 months;&#xD;
  &#xD;
            5. The subjects' WOMAC score was 24-72, and the WOMAC pain score was 7-17 (the WOMAC&#xD;
               score at least 48 hours after discontinuation of all painkillers);&#xD;
  &#xD;
            6. The Kellgren Lawrence grade (X-ray axial position of knee joint) of subjects was grade&#xD;
               II / III;&#xD;
  &#xD;
            7. Subjects are generally in good condition and can walk autonomously, except for those&#xD;
               who use wheelchairs, walking aids or crutches.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. The subject may be allergic to the main cell preparation components (B vitamins, amino&#xD;
               acids and so on).&#xD;
  &#xD;
            2. The subject received systemic and / or local treatment with autologous and / or&#xD;
               allogeneic mesenchymal progenitor cells.&#xD;
  &#xD;
            3. The subject has a BMI of over 30.&#xD;
  &#xD;
            4. Laboratory test (any item meets): neutrophil absolute number &lt; 1.0 × 10^9 / L,&#xD;
               platelet count &lt; 50 × 10^9 / L, serum albumin &lt; 30g / L, serum creatinine &gt; upper&#xD;
               limit of 1.2 times normal value range, total bilirubin、alanine&#xD;
               aminotransferase、aspartate aminotransferase &gt; upper limit of 2 times of normal value&#xD;
               range.&#xD;
  &#xD;
            5. The subject has diseases or symptoms may affect VAS, WOMAC and so on.&#xD;
  &#xD;
            6. The subject has serious and poorly controlled concomitant diseases, such as (but not&#xD;
               limited to) nervous system, cardiovascular, liver, kidney, gastrointestinal and&#xD;
               endocrine diseases, which may prevent the subjects from participating in the study&#xD;
               according to the judgment of the researchers.&#xD;
  &#xD;
            7. The subject has an history malignant tumour.&#xD;
  &#xD;
            8. The subject has connective tissue disease or rheumatoid&#xD;
               arthritis、chondropathy、Chondrocalcinosis articularis、 Hemochromatosis、inflammatory&#xD;
               arthropathy、avascular necrosis of femoral head、Paget's disease、hemophilic&#xD;
               arthropathy、infectional arthritis、Charcot' s disease、villonodular synovitis or&#xD;
               synovial chondromatosis.&#xD;
  &#xD;
            9. The subject has severe generalized infectious diseases or local knee infection&#xD;
               (including skin and intra-articular infection) in the 3 months prior to this trial.&#xD;
  &#xD;
           10. According to the researchers, the subject has disease of lower limbs which may be&#xD;
               interfered knee evaluation, for example fibromyalgia, osphyalgia, lumbar disc&#xD;
               protrusion and so on.&#xD;
  &#xD;
           11. The subject had any other coagulation dysfunction caused by acute or chronic diseases,&#xD;
               according to the judgment of the researchers, this coagulation dysfunction may&#xD;
               endanger the safety of patients and / or affect the judgment of knee joint evaluation&#xD;
               indicators.&#xD;
  &#xD;
           12. The subject has received arthroscopic surgery or other open surgery related to knee&#xD;
               joint operation in the 6 months prior to this trial.&#xD;
  &#xD;
           13. The subject has received other intra-articular injections, including but not limited&#xD;
               to hyaluronic acid, hormone, PRP, BMP (bone morphogenetic protein) , hypertonic&#xD;
               glucose and so on for KOA in the 3 months preceding the trial.&#xD;
  &#xD;
           14. The subject has received aminoglucose or chondroitin sulfate within 1 month before the&#xD;
               treatment.&#xD;
  &#xD;
           15. The subject has used dexamethasone, prednisone, hydrocortisone and other hormones&#xD;
               orally / intravenously within 1 month before the treatment.&#xD;
  &#xD;
           16. The subject has attenuated or live attenuated vaccine injection with 1 month before&#xD;
               the treatment.&#xD;
  &#xD;
           17. The subject has undergone knee prosthesis or a plan of knee prosthesis within the&#xD;
               trial.&#xD;
  &#xD;
           18. The subject has contraindication of MRI, included but not only: the subject installed&#xD;
               heart pacemaker, defibrillator, heart bracket, heart valve prosthesis, metal clip&#xD;
               after aneurysm surgery, drug infusion device implanted in vivo, any electronic device&#xD;
               implanted in the body (nerve stimulator, bone growth stimulator) endovascular coil,&#xD;
               strainer, ECG monitor, metal suture, shrapnel or sand of body, plate fixation and&#xD;
               steel nail after fracture surgery, artificial cochlea, middle ear shift plant,&#xD;
               metallic intraocular foreign body etc; the subject is a claustrophobia, critical ill&#xD;
               patient and so on.&#xD;
  &#xD;
           19. The subject tests positive for: HIV, HBV, HCV and treponema pallidum.&#xD;
  &#xD;
           20. The subject has history of alcoholism, drug abuse, or mental illness in the 3 years&#xD;
               prior to this trial.&#xD;
  &#xD;
           21. The subject has participated in any other clinical trial in the 3 months prior to this&#xD;
               trial.&#xD;
  &#xD;
           22. The subject (including male subjects) has fertility, sperm donation or egg donation&#xD;
               plans during the trial period; the female subject is pregnant, lactating or having a&#xD;
               positive pregnancy test.&#xD;
  &#xD;
           23. The subject is legally disabled by reference to the law of the people's Republic of&#xD;
               China on the protection of disabled persons (April 2008).&#xD;
  &#xD;
           24. The subject has any other unsuitable condition (such as factors reducing the follow-up&#xD;
               compliance) to be determined by the investigator.&#xD;
  &#xD;
           25. The Kellgren Lawrence grade (X-ray axial position of knee joint) of any knee joint of&#xD;
               the subjects was grade IV.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>40 Years</minimum_age>
      <maximum_age>75 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Chunde Bao, M.D. &amp; Ph.D.</last_name>
      <phone>M.D. &amp; Ph.D.</phone>
      <email>xck@renji.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Department of Rheumatology,Ren Ji Hospital,School of Medicine,Shanghai Jiao Tong University,Shanghai,China</name>
        <address>
          <city>Shanghai</city>
          <state>Shanghai</state>
          <zip>200127</zip>
          <country>China</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>China-Japan Friendship Hospital</name>
        <address>
          <city>Beijing</city>
          <zip>100029</zip>
          <country>China</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>The Second Affiliated hospital of Zhejiang University School of Medicine</name>
        <address>
          <city>Hangzhou</city>
          <zip>310009</zip>
          <country>China</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Huashan Hospital Affiliated to Fudan University</name>
        <address>
          <city>Shanghai</city>
          <zip>200040</zip>
          <country>China</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Shanghai General Hospital</name>
        <address>
          <city>Shanghai</city>
          <zip>200080</zip>
          <country>China</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Shanghai Ninth People's Hospital, Shanghai JiaoTong University School of Medicine</name>
        <address>
          <city>Shanghai</city>
          <country>China</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>May 8, 2023</study_first_submitted>
    <study_first_submitted_qc>August 9, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 18, 2023</study_first_posted>
    <last_update_submitted>August 9, 2023</last_update_submitted>
    <last_update_submitted_qc>August 9, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 18, 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>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Hyaluronic Acid</mesh_term>
    </intervention_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/NCT05996224
  org study id: CBM-MPC-007
  nct id: NCT05996224
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  Evaluate the efficacy and safety of Allogenic Adipose Tissue-Derived Mesenchymal Progenitor
        Cells Therapy
  A Multicenter, Randomized, Double-blind, Controlled Phase III Trial of Allogenic Adipose
        Tissue-Derived Mesenchymal Progenitor Cells (AlloJoin®) Therapy for Knee Osteoarthritis.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Double (Participant, Investigator)
  measure: WOMAC score
  time frame: 24 weeks
  description: The Western Ontario and McMaster Universities Osteoarthritis Index;0-96 points；96 points mean a worse outcome,will be tested at 24 weeks after the first injection
  measure: MRI quantitative analysis of articular cartilage
  time frame: 48 weeks
  description: Magnetic Resonance Imaging analysis of articular cartilage, will be tested at 48 weeks after the first injection
  measure: WOMAC Score
  time frame: 4、12、24、36、48、60、72、84、96 weeks
  description: The Western Ontario and McMaster Universities Osteoarthritis Index;0-96 points；96 points mean a worse outcome, will be tested at 4、12、24、36、48、60、72、84 and 96 weeks after the first injection
  measure: VAS Score
  time frame: 4、12、24、36、48、60、72、84、96 weeks
  description: Visual Analogue Scale/Score；0-10 points；10 points mean the worse outcome,will be tested at 4、12、24、36、48、60、72、84 and 96 weeks after the first injection
  measure: SF-36
  time frame: 4、12、24、36、48、60、72、84、96 weeks
  description: The Medical Outcomes Study 36-Item Short-Form Health Survey;0-100 points；100 points mean a better outcome, will be tested at 4、12、24、36、48、60、72、84 and 96 weeks after the first injection
  measure: MRI quantitative analysis of articular cartilage
  time frame: 24 weeks and 96 weeks
  description: Magnetic Resonance Imaging analysis of articular cartilage, will be tested at 24 and 96 weeks after the first injection
  measure: Whole-Organ Magnetic Resonance Imaging Score
  time frame: 24、48 and 96 weeks
  description: Whole-Organ Magnetic Resonance Imaging Score(WORMS) of the knee; 0-332points; 332 points means the worst outcome; will be assessed at 24、48 and 96 weeks
  measure: mJSW
  time frame: 96 weeks
  description: Minimum joint space width (mJSW) of the knee, will be measured at baseline and 96 weeks
  measure: Adverse Events and Serious Adverse Events
  time frame: Day 0 to 96 weeks
  description: AE and SAE, will be assessed within the 96 week time span
  measure: Physical examination
  time frame: Day 0、week 1、2、3、4、12、24、36、48、60、72、84、96
  description: Height and weight will be tested and combined to report BMI in kg/m^2at Day 0 and week 1、2、3、4、12、24、36、48、60、72、84、96
  measure: Inflammatory biomarkers detection
  time frame: Day 0 and week 4、12、24、36、48、96
  description: Prostaglandin E2 in serum will be tested at Day 0 and week 4、12、24、36、48、96
  arm group label: Mesenchymal progenitor cells
  arm group type: Experimental
  description: Mesenchymal progenitor cells group
  arm group label: Sodium hyaluronate
  arm group type: Active Comparator
  description: Sodium hyaluronate injection group
  intervention type: Biological
  intervention name: Mesenchymal progenitor cells
  description: Allogenic Adipose tissue-derived mesenchymal progenitor cells administrated for intra- articular use
  arm group label: Mesenchymal progenitor cells
  intervention type: Drug
  intervention name: Sodium Hyaluronate Injection
  description: Sodium Hyaluronate administrated for intra-articular use
  arm group label: Sodium hyaluronate
  other name: Hyaluronic acid injection
  criteria: 
  gender: All
  minimum age: 40 Years
  maximum age: 75 Years
  healthy volunteers: No
  last name: Chunde Bao, M.D. & Ph.D.
  phone: M.D. & Ph.D.
  email: xck@renji.com
  facility: 
  facility: 
  facility: 
  facility: 
  facility: 
  facility: 
  country: China
  responsible party type: Sponsor
  mesh term: Osteoarthritis
  mesh term: Osteoarthritis, Knee
  mesh term: Hyaluronic Acid