<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/NCT01694823</url>
  </required_header>
  <id_info>
    <org_study_id>CS-ACI2012001</org_study_id>
    <nct_id>NCT01694823</nct_id>
  </id_info>
  <brief_title>Safety and Efficacy Study of Cells Sheet-Autologous Chondrocyte Implantation to Treat Articular Cartilage Defects</brief_title>
  <acronym>CS-ACI</acronym>
  <official_title>A Prospective Open-label Multi-center Study to Demonstrate the Safety and Efficacy of Cells Sheet-Autologous Chondrocyte Implantation（CS-ACI）for the Treatment of Articular Cartilage Defects</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Yan Jin</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Xijing Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Tang-Du Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Air Force Military Medical University, China</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      In this study,the Autologous chondrocyte implantation (ACI)technology and cell sheet&#xD;
      technology are used to Cells Sheet-Autologous Chondrocyte Implantation(CS-ACI) for treating&#xD;
      Cartilage Defects.The Safety and Efficacy Study of CS-ACI are evaluated.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      All procedures are carried out after obtaining informed written consent from patients.&#xD;
      Cartilage tissue is acquired from the Non-weight-bearing area of patients. chondrocyte are&#xD;
      isolated and grown in culture for 6-8 weeks. After this time interval, the cells are&#xD;
      reprocessed and the cell sheet is obtained. Implantation of the chondrocyte sheet into the&#xD;
      Cartilage defect of the keen.The patients will be assessed clinically with scoring systems&#xD;
      preoperatively as well as 24 months postoperatively to assess relief of symptoms and joint&#xD;
      function. Radiological assessment (MRIs)of the affected joints will be performed at the same&#xD;
      time points aforementioned to assess integrity of the formed cartilage. Second look&#xD;
      arthroscopy and biopsy will also be performed to histologically assess the repair tissue and&#xD;
      grade it via arthroscopic grading system according to the International Cartilage Repair&#xD;
      Society guidelines.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>April 2012</start_date>
  <completion_date type="Anticipated">June 2015</completion_date>
  <primary_completion_date type="Anticipated">July 2013</primary_completion_date>
  <phase>Phase 1/Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Mean change from baseline in the MRI</measure>
    <time_frame>3month,6 month, 12 months, 24 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline in the Lysholm</measure>
    <time_frame>3month,6 month, 12 months, 24 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline in the Knee injury and Osteoarthritis Outcome Score (KOOS)Which consists of five sub- categories = Pain, ADL, QOL, Symptoms, Sport</measure>
    <time_frame>3month,6 month, 12 months, 24 months</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">10</enrollment>
  <condition>Osteochondritis</condition>
  <condition>Osteochondritis Dissecans</condition>
  <condition>Joint Diseases</condition>
  <arm_group>
    <arm_group_label>CS-ACI</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Group/Cohort Label： pretherapy post-treatment&#xD;
Group/Cohort Description ：The CS-ACI is used to prepare cell sheet and implant to the Cartilage defects.The arm of safety and efficacy are compared preoperative observation with postoperative observation.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>CS-ACI</intervention_name>
    <description>Procedure: Self-control. Cells Sheet-Autologous Chondrocyte Implantation(CS-ACI) includes an arthroscopy for harvesting of cartilage 6-8 weeks prior to the open cartilage surgery. Other Names:&#xD;
Cells Sheet-Autologous Chondrocyte Implantation （CS-ACI）</description>
    <arm_group_label>CS-ACI</arm_group_label>
    <other_name>Cells Sheet-Autologous Chondrocyte Implantation（ CS-ACI）</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or female patients, age: between 18 and 50 years&#xD;
&#xD;
          -  Defect: isolated ICRS grade III or IV single defect chondral lesions on Articular&#xD;
             Cartilage&#xD;
&#xD;
          -  Defect size: 2.5 to &lt; 5 cm2 after debridement to healthy cartilage up to 6 mm in&#xD;
             depth.&#xD;
&#xD;
          -  Nearly intact chondral structure surrounding the defect as well as an intact&#xD;
             corresponding joint area&#xD;
&#xD;
          -  Informed consent signed and dated by patient and Patient understands the strict&#xD;
             rehabilitation protocol and follow-up programme and is willing to follow it&#xD;
&#xD;
          -  No ligament damage or ligament damage after reconstruction&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients younger than 18 years and older than 50 years.&#xD;
&#xD;
          -  Arthrofibrosis or Ankylosis&#xD;
&#xD;
          -  Arthritis&#xD;
&#xD;
          -  Obesity&#xD;
&#xD;
          -  Infectious diseases&#xD;
&#xD;
          -  the other cases of patients which Doctors determine not 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>Jin Yan, Ph.D</last_name>
    <role>Study Director</role>
    <affiliation>Research and Development Center for Tissue Engineering,Fourth Military Medical University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Xijing Hospital</name>
      <address>
        <city>Xi'an Shi</city>
        <zip>710032</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>zhang Chunli, MD</last_name>
      <phone>86-029-84771339</phone>
      <email>zhangcl816@sohu.com</email>
    </contact>
    <investigator>
      <last_name>zhang chunli, Ph.D</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Tangdu Hospital</name>
      <address>
        <city>Xi'an Shi</city>
        <zip>710038</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>ding yong, Ph.D</last_name>
      <phone>86-029-84717700</phone>
      <email>dinyonza@fmmu.edu.cn</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Xi'An Honghui Hospital</name>
      <address>
        <city>Xi'an Shi</city>
        <zip>710054</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>zheng jiang</last_name>
      <phone>86-0 18802940279</phone>
      <email>zhengjiang1010@126.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <reference>
    <citation>Ebihara G, Sato M, Yamato M, Mitani G, Kutsuna T, Nagai T, Ito S, Ukai T, Kobayashi M, Kokubo M, Okano T, Mochida J. Cartilage repair in transplanted scaffold-free chondrocyte sheets using a minipig model. Biomaterials. 2012 May;33(15):3846-51. doi: 10.1016/j.biomaterials.2012.01.056. Epub 2012 Feb 25.</citation>
    <PMID>22369960</PMID>
  </reference>
  <verification_date>September 2012</verification_date>
  <study_first_submitted>September 24, 2012</study_first_submitted>
  <study_first_submitted_qc>September 24, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 27, 2012</study_first_posted>
  <last_update_submitted>September 28, 2012</last_update_submitted>
  <last_update_submitted_qc>September 28, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 1, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Air Force Military Medical University, China</investigator_affiliation>
    <investigator_full_name>Yan Jin</investigator_full_name>
    <investigator_title>Director of Research and Development Center for Tissue Engineering</investigator_title>
  </responsible_party>
  <keyword>Cartilage repair</keyword>
  <keyword>Cartilage defects</keyword>
  <keyword>cell sheet</keyword>
  <keyword>Autologous chondrocyte implantation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Joint Diseases</mesh_term>
    <mesh_term>Osteochondritis</mesh_term>
    <mesh_term>Osteochondritis Dissecans</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/NCT01694823
org study id: CS-ACI2012001
nct id: NCT01694823
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
In this study,the Autologous chondrocyte implantation (ACI)technology and cell sheet
      technology are used to Cells Sheet-Autologous Chondrocyte Implantation(CS-ACI) for treating
      Cartilage Defects.The Safety and Efficacy Study of CS-ACI are evaluated.
All procedures are carried out after obtaining informed written consent from patients.
      Cartilage tissue is acquired from the Non-weight-bearing area of patients. chondrocyte are
      isolated and grown in culture for 6-8 weeks. After this time interval, the cells are
      reprocessed and the cell sheet is obtained. Implantation of the chondrocyte sheet into the
      Cartilage defect of the keen.The patients will be assessed clinically with scoring systems
      preoperatively as well as 24 months postoperatively to assess relief of symptoms and joint
      function. Radiological assessment (MRIs)of the affected joints will be performed at the same
      time points aforementioned to assess integrity of the formed cartilage. Second look
      arthroscopy and biopsy will also be performed to histologically assess the repair tissue and
      grade it via arthroscopic grading system according to the International Cartilage Repair
      Society guidelines.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Mean change from baseline in the MRI
time frame: 3month,6 month, 12 months, 24 months
measure: Change from Baseline in the Lysholm
time frame: 3month,6 month, 12 months, 24 months
measure: Change from Baseline in the Knee injury and Osteoarthritis Outcome Score (KOOS)Which consists of five sub- categories = Pain, ADL, QOL, Symptoms, Sport
time frame: 3month,6 month, 12 months, 24 months
arm group label: CS-ACI
arm group type: Experimental
description: Group/Cohort Label： pretherapy post-treatment
Group/Cohort Description ：The CS-ACI is used to prepare cell sheet and implant to the Cartilage defects.The arm of safety and efficacy are compared preoperative observation with postoperative observation.
intervention type: Drug
intervention name: CS-ACI
description: Procedure: Self-control. Cells Sheet-Autologous Chondrocyte Implantation(CS-ACI) includes an arthroscopy for harvesting of cartilage 6-8 weeks prior to the open cartilage surgery. Other Names:
Cells Sheet-Autologous Chondrocyte Implantation （CS-ACI）
arm group label: CS-ACI
other name: Cells Sheet-Autologous Chondrocyte Implantation（ CS-ACI）
criteria: 
gender: All
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: No
last name: Jin Yan, Ph.D
role: Study Director
affiliation: Research and Development Center for Tissue Engineering,Fourth Military Medical University
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
country: China
citation: Ebihara G, Sato M, Yamato M, Mitani G, Kutsuna T, Nagai T, Ito S, Ukai T, Kobayashi M, Kokubo M, Okano T, Mochida J. Cartilage repair in transplanted scaffold-free chondrocyte sheets using a minipig model. Biomaterials. 2012 May;33(15):3846-51. doi: 10.1016/j.biomaterials.2012.01.056. Epub 2012 Feb 25.
PMID: 22369960
responsible party type: Sponsor-Investigator
investigator affiliation: Air Force Military Medical University, China
investigator full name: Yan Jin
investigator title: Director of Research and Development Center for Tissue Engineering
mesh term: Joint Diseases
mesh term: Osteochondritis
mesh term: Osteochondritis Dissecans