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Introduction of ACI for Cartilage Repair

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ClinicalTrials.gov Identifier: NCT04296487
Recruitment Status : Recruiting
First Posted : March 5, 2020
Last Update Posted : March 6, 2020
Sponsor:
Information provided by (Responsible Party):
Dr. Robin Martin, Centre Hospitalier Universitaire Vaudois

Tracking Information
First Submitted Date  ICMJE August 1, 2019
First Posted Date  ICMJE March 5, 2020
Last Update Posted Date March 6, 2020
Actual Study Start Date  ICMJE September 1, 2017
Estimated Primary Completion Date September 1, 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 4, 2020)
  • Rate of implantation-associated complications: serious adverse events (SAEs) and serious adverse reactions (SARs) [ Time Frame: Up to 12 months. ]
    Post-implantation data collection: Types, probability and severity of treatment (inflammation, infection,pain, joint effusion, delamination, transplant rejection, fibrocartilage, incomplete cartilage reparation).
  • Change in tissue integrity into and around the treated aera [ Time Frame: 3 months post-implantation ]
    MRI analysis
  • Absence of infection after implantation. [ Time Frame: 6 weeks post-implantation ]
    Absence of infection is assessed in blood sample by the quantification of three parameters: C-reactive Protein (CRP), neutrophil and lymphocyte rate. The non-infection is characterised by a CRP rate < 10 mg/L, neutrophil rate ranges from 40-75% and lymphocyte rate ranges from 25-40%.
Original Primary Outcome Measures  ICMJE
 (submitted: March 4, 2020)
  • Rate of implantation-associated complications: serious adverse events (SAEs) and serious adverse reactions (SARs) [ Time Frame: Up to 12 months. ]
    Post-implantation data collection: Types, probability and severity of treatment (inflammation, infection,pain, joint effusion, delamination, transplant rejection, fibrocartilage, incomplete cartilage reparation).
  • Change in tissue integrity into and around the treated aera [ Time Frame: 3 months post-implantation ]
    MRI analysis
  • A potential infection after implantation is assessed in blood sample by C-reactive Protein (CRP), neutrophile and lymphocyte quantification. [ Time Frame: 6 weeks post-implantation ]
    Absence of infection is characterised by CRP rate < 10 mg/L, neutrophile proportion ranges from 40-75% and lymphocyte proportion ranges from 25-40%
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: March 4, 2020)
  • Self-reported function and knee-related quality of life are assessed by using the Knee injury and Osteoarthritis Outcome Score (KOOS) [ Time Frame: Change from baseline to 12 months post-implantation. ]
    KOOS includes five subscales: symptoms, pain, activities of daily living, function in sport/recreation, and knee-related quality of life. A score in points for each subscale will be calculated, and it ranges from 0 (worst score) to 100 (best score).
  • Self-reported physical pain and function are assessed by International Knee Documentation Committee score (IKDC) [ Time Frame: Change from baseline to 12 months post-implantation ]
    A score will be calculated, and it ranges from 0 (worst score) to 100 (best score).
  • Self-reported functional health and weel-being as assessed by SF12 Survey [ Time Frame: Change from baseline to 12 months post-implantation ]
    SF12 survey includes 2 subscales: mental component summary (MCS) and physical component summery (PCS). A score in points for each subscale will be calculated, and it ranges from 0 (worst score) to 100 (best score).
  • The cartilage repair is assesed by Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) scoring system. [ Time Frame: Change from baseline to12 months post-implantation ]
    MOCART scoring system is based on MRI analysis. A score in points will be calculated, and it ranges from 0 points (no repair) to 100 points (excellent cartilage defect repair)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Introduction of ACI for Cartilage Repair
Official Title  ICMJE Introduction of Autologous Chondrocyte Implantation Procedure for the Treatment of Chondral Defect in the Knee
Brief Summary This study was aimed to evaluate effectiveness and safety of autologous chondrocyte suspension for treatment of knee articular cartilage defects.
Detailed Description
  • Prospective and interventional study
  • All procedures are carried out after obtaining informed written consent from patients.
  • Study procedures involve a biopsy, cell production, cell implantation and follow-up including a strict post-surgery rehabilitation protocol (12 month timepoint)
  • All subjects will be assessed at intervals post-implantation (6 weeks, 3 months, 6 months and 12 months).
  • Measures to assess effectiveness and safety will be conducted at follow-ups: Magnetic Resonance Imaging (MOCART score), collection of adverse events, orthopaedic scores (KOOS, IKDC, SF12v2)
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Articular Cartilage Defect
  • Chondral Defect
  • Osteochondritis
Intervention  ICMJE Other: autologous chondrocytes
autologous chondrocytes implantation (ACI)
Study Arms  ICMJE Experimental: Autologous Chondrocyte Injection
Autologous chondrocytes were isolated and expanded in laboratory, then injected at 2x10^6 of cells per cm^2 of the cartilage defect.
Intervention: Other: autologous chondrocytes
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 4, 2020)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 1, 2025
Estimated Primary Completion Date September 1, 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Age between 15 and 50.
  2. Lesions classified as ICRS Grade III or IV and smaller than 15 cm2
  3. Lesions that have failed prior therapy (conservative or surgical treatment ≥ six months)
  4. Subjects who understand and sign the consent form for this study

Exclusion Criteria:

  1. Body mass index (BMI) of 35 or more
  2. Osteoarthritis or rheumatoid arthritis
  3. Diffuse lesion
  4. Uncorrected mal-alignment, ligamentous instability, or meniscal tear
  5. Presence of growth cartilage (15-18 years old)
  6. Active smoking or drug consumption
  7. Women who are pregnant
  8. Positive serology for HIV-1 or HIV-2, Hepatitis B and C and syphilis
  9. Proven allergy to porcine collagen, penicillin and gentamicin
  10. Poor compliance
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 15 Years to 50 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Robin MARTIN, MD 021 314 76 79 ext 41 robin.martin@chuv.ch
Contact: Virginie PHILIPPE, Ph-D 021 314 90 18 ext 41 virginie.philippe@chuv.ch
Listed Location Countries  ICMJE Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04296487
Other Study ID Numbers  ICMJE ACI-OTR
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dr. Robin Martin, Centre Hospitalier Universitaire Vaudois
Study Sponsor  ICMJE Centre Hospitalier Universitaire Vaudois
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Robin MARTIN, MD CHUV
PRS Account Centre Hospitalier Universitaire Vaudois
Verification Date March 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP