<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/NCT04463238</url>
  </required_header>
  <id_info>
    <org_study_id>2015035</org_study_id>
    <nct_id>NCT04463238</nct_id>
  </id_info>
  <brief_title>Guided Cartilage Regeneration Membrane</brief_title>
  <acronym>GCRM</acronym>
  <official_title>Randomized Open Multicenter Clinical Study to Evaluate the Safety and Effectiveness of Guided Cartilage Regeneration Membrane for Repair of Articular Cartilage Injury</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Peking University Third Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Zhongnan Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Second Hospital of Shanxi Medical University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>First Affiliated Hospital of Kunming Medical University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Zunyi Medical College</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The First Affiliated Hospital of Zhengzhou University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Chinese PLA General Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Xi'an Honghui Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Peking University Third Hospital</source>
  <oversight_info>
    <has_dmc>Yes</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>
      Guided cartilage regeneration membrane for repairing the safety and effectiveness of&#xD;
      articular cartilage injury&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      MRI evaluation using guided cartilage regeneration membrane for articular cartilage injury&#xD;
      repair 730 days (2 years) is the main indicator of this trial. In this experiment, we observe&#xD;
      the improvement of Lysholm score, VAS score, ratio change of regenerated cartilage T2 value&#xD;
      to normal cartilage T2 value, and ratio of regenerated cartilage △R1 value to normal&#xD;
      cartilage △R1 value Indicators such as value changes are secondary evaluation indicators.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">August 3, 2020</start_date>
  <completion_date type="Anticipated">August 3, 2023</completion_date>
  <primary_completion_date type="Anticipated">August 3, 2022</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>GCRM-3020\GCRM-4030</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>MRI evaluation of articular cartilage injury 730 days (2 years) after repair</measure>
    <time_frame>End of surgery to 730 days after surgery</time_frame>
    <description>The nuclear magnetic evaluation indicators are as follows:&#xD;
Cartilage defect repair filling degree;&#xD;
Fusion of repair tissue and adjacent normal cartilage;&#xD;
Repair tissue surface structure;&#xD;
Repair the internal structure of the organization.&#xD;
The MRI score of the experimental group before and after treatment increased by an average of 5 points compared with the control group.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in ratio of regenerated cartilage T2 value to normal cartilage T2 value</measure>
    <time_frame>At 24 months after surgery</time_frame>
    <description>The closer the ratio of the regenerated cartilage T2 value to the normal control cartilage T2 value is 1, it means that the regenerated cartilage The closer the water content and collagen arrangement are to normal cartilage.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in ratio of regenerated cartilage △R1 value to normal cartilage △R1 value</measure>
    <time_frame>At 24 months after surgery</time_frame>
    <description>The closer the ratio of the regenerated cartilage △R1 value to the normal control cartilage △R1 value is 1, it means that the GAG content of regenerated cartilage is closer to normal cartilage.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">150</enrollment>
  <condition>Articular Cartilage Injury</condition>
  <condition>Knee Ligament Injury</condition>
  <arm_group>
    <arm_group_label>Cartilage membrane surgery</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The test group applied the guidance provided by Shaanxi Baiao Regenerative Medicine Co., Ltd.&#xD;
Cartilage regeneration membrane combined with microfracture surgery.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Microfracture</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>The control group was treated with microfractures widely recognized at home and abroad.</description>
  </arm_group>
  <intervention>
    <intervention_type>Combination Product</intervention_type>
    <intervention_name>Guided cartilage regeneration membrane</intervention_name>
    <description>On the basis of microfracture, the blood clot released from the defect area is covered with a guide cartilage regeneration membrane to provide an attached scaffold for the cells in the blood clot.</description>
    <arm_group_label>Cartilage membrane surgery</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Microfracture</intervention_name>
    <description>Operate in accordance with the clinical microfracture surgery method.</description>
    <arm_group_label>Cartilage membrane surgery</arm_group_label>
    <arm_group_label>Microfracture</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. ≥18 years old and ≤50 years old, regardless of gender&#xD;
&#xD;
          2. 2 cm2 ≤ articular cartilage defect repair area ≤ 8 cm2, patients with feasible&#xD;
             micro-fractures, no contraindications to surgery&#xD;
&#xD;
          3. Patients voluntarily participate in clinical trials, sign informed consent forms, and&#xD;
             can cooperate with clinical follow-up&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Those who have participated in clinical trials of other drugs or medical devices in&#xD;
             the last 6 months&#xD;
&#xD;
          2. Those with stage III or above degeneration of bone and joint&#xD;
&#xD;
          3. Those who cannot accept pig-derived devices or have special religious beliefs due to&#xD;
             religion, ethnicity and other issues&#xD;
&#xD;
          4. Those who are sensitive to collagen, foreign protein or pig-derived materials&#xD;
&#xD;
          5. Repair the damaged area&gt; 8 cm2 or &lt;2 cm2, lack of normal cartilage tissue around the&#xD;
             injury&#xD;
&#xD;
          6. Severe heart, liver and kidney insufficiency are defined as:&#xD;
&#xD;
             Heart function: NYHA grade III or above; ALT, AST&gt; 2.5 times the upper limit of normal&#xD;
             value; Serum creatinine&gt; 1.5 times the upper limit of normal value;&#xD;
&#xD;
          7. People with systemic immune diseases or systemic or local infections&#xD;
&#xD;
          8. Joint fibrosis, joint stiffness, and obviously restricted movement&#xD;
&#xD;
          9. Those with moderate or severe osteoarthritis&#xD;
&#xD;
         10. People with contraindications for MRI examination&#xD;
&#xD;
         11. Patients with hemophilia&#xD;
&#xD;
         12. Those who cannot tolerate surgery&#xD;
&#xD;
         13. Women who are pregnant or plan to become pregnant and breastfeeding women&#xD;
&#xD;
         14. Persons with mental abnormalities and incapacity to act autonomously&#xD;
&#xD;
         15. Other conditions that the doctor judges cannot participate in the trial&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yingfang Ao, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Sports Medicine, Peking University Third Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Xiaoqing Hu, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Department of Sports Medicine, Peking University Third Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Yingfang Ao, PhD</last_name>
    <phone>13401096777</phone>
    <phone_ext>13401096777</phone_ext>
    <email>gcrm_bys01@163.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Chinese PLA General Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing Municipality</state>
        <zip>100853</zip>
        <country>China</country>
      </address>
    </facility>
    <contact>
      <last_name>Zhongli Li, PhD</last_name>
    </contact>
    <investigator>
      <last_name>Zhongli Li, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Zunyi Medical College</name>
      <address>
        <city>Zunyi</city>
        <state>Guizhou</state>
        <zip>563000</zip>
        <country>China</country>
      </address>
    </facility>
    <contact>
      <last_name>Yi Liu, Bachelor</last_name>
    </contact>
    <investigator>
      <last_name>Hehe Zhong, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>The First Affiliated Hospital of Zhengzhou University</name>
      <address>
        <city>Zhengzhou</city>
        <state>Henan</state>
        <zip>450000</zip>
        <country>China</country>
      </address>
    </facility>
    <contact>
      <last_name>Jianzhong Xu, PhD</last_name>
    </contact>
    <investigator>
      <last_name>Jianzhong Xu, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Zhongnan Hospital</name>
      <address>
        <city>Wuhan</city>
        <state>Hubei</state>
        <zip>430071</zip>
        <country>China</country>
      </address>
    </facility>
    <contact>
      <last_name>Liaobin Chen, PhD</last_name>
    </contact>
    <investigator>
      <last_name>Biao Chen, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School</name>
      <address>
        <city>Nanjing</city>
        <state>Jiangsu</state>
        <zip>210008</zip>
        <country>China</country>
      </address>
    </facility>
    <contact>
      <last_name>Qing Jiang, PhD</last_name>
    </contact>
    <investigator>
      <last_name>Jin Dai, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Second Hospital of Shanxi Medical University</name>
      <address>
        <city>Taiyuan</city>
        <state>Shanxi</state>
        <zip>030012</zip>
        <country>China</country>
      </address>
    </facility>
    <contact>
      <last_name>Zhiqiang Zhang, Postgraduate</last_name>
    </contact>
    <investigator>
      <last_name>Junjun Shi, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Xi'an Honghui Hospital</name>
      <address>
        <city>Xi'an</city>
        <state>Shanxi</state>
        <zip>710000</zip>
        <country>China</country>
      </address>
    </facility>
    <contact>
      <last_name>Jiang Zheng, PhD</last_name>
    </contact>
    <investigator>
      <last_name>Jiang Zheng, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>The First Affiliated Hospital of Kunming Medical College</name>
      <address>
        <city>Kunming</city>
        <state>Yunnan</state>
        <zip>650032</zip>
        <country>China</country>
      </address>
    </facility>
    <contact>
      <last_name>Yanlin Li, PhD</last_name>
    </contact>
    <investigator>
      <last_name>Yanlin Li, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 3, 2020</study_first_submitted>
  <study_first_submitted_qc>July 3, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 9, 2020</study_first_posted>
  <last_update_submitted>July 3, 2020</last_update_submitted>
  <last_update_submitted_qc>July 3, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 9, 2020</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>Wounds and Injuries</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/NCT04463238
org study id: 2015035
nct id: NCT04463238
lead sponsor: 
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has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Guided cartilage regeneration membrane for repairing the safety and effectiveness of
      articular cartilage injury
MRI evaluation using guided cartilage regeneration membrane for articular cartilage injury
      repair 730 days (2 years) is the main indicator of this trial. In this experiment, we observe
      the improvement of Lysholm score, VAS score, ratio change of regenerated cartilage T2 value
      to normal cartilage T2 value, and ratio of regenerated cartilage △R1 value to normal
      cartilage △R1 value Indicators such as value changes are secondary evaluation indicators.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: GCRM-3020\GCRM-4030
primary purpose: Treatment
masking: None (Open Label)
measure: MRI evaluation of articular cartilage injury 730 days (2 years) after repair
time frame: End of surgery to 730 days after surgery
description: The nuclear magnetic evaluation indicators are as follows:
Cartilage defect repair filling degree;
Fusion of repair tissue and adjacent normal cartilage;
Repair tissue surface structure;
Repair the internal structure of the organization.
The MRI score of the experimental group before and after treatment increased by an average of 5 points compared with the control group.
measure: Change in ratio of regenerated cartilage T2 value to normal cartilage T2 value
time frame: At 24 months after surgery
description: The closer the ratio of the regenerated cartilage T2 value to the normal control cartilage T2 value is 1, it means that the regenerated cartilage The closer the water content and collagen arrangement are to normal cartilage.
measure: Change in ratio of regenerated cartilage △R1 value to normal cartilage △R1 value
time frame: At 24 months after surgery
description: The closer the ratio of the regenerated cartilage △R1 value to the normal control cartilage △R1 value is 1, it means that the GAG content of regenerated cartilage is closer to normal cartilage.
arm group label: Cartilage membrane surgery
arm group type: Experimental
description: The test group applied the guidance provided by Shaanxi Baiao Regenerative Medicine Co., Ltd.
Cartilage regeneration membrane combined with microfracture surgery.
arm group label: Microfracture
arm group type: Other
description: The control group was treated with microfractures widely recognized at home and abroad.
intervention type: Combination Product
intervention name: Guided cartilage regeneration membrane
description: On the basis of microfracture, the blood clot released from the defect area is covered with a guide cartilage regeneration membrane to provide an attached scaffold for the cells in the blood clot.
arm group label: Cartilage membrane surgery
intervention type: Procedure
intervention name: Microfracture
description: Operate in accordance with the clinical microfracture surgery method.
arm group label: Cartilage membrane surgery
arm group label: Microfracture
criteria: 
gender: All
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: No
last name: Yingfang Ao, PhD
role: Principal Investigator
affiliation: Department of Sports Medicine, Peking University Third Hospital
last name: Xiaoqing Hu, PhD
role: Study Director
affiliation: Department of Sports Medicine, Peking University Third Hospital
last name: Yingfang Ao, PhD
phone: 13401096777
phone ext: 13401096777
email: gcrm_bys01@163.com
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contact: 
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country: China
responsible party type: Sponsor
mesh term: Wounds and Injuries
sharing ipd: No