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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

Brief Summary:
This study was aimed to evaluate effectiveness and safety of autologous chondrocyte suspension for treatment of knee articular cartilage defects.

Condition or disease Intervention/treatment Phase
Articular Cartilage Defect Chondral Defect Osteochondritis Other: autologous chondrocytes Not Applicable

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)

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Introduction of Autologous Chondrocyte Implantation Procedure for the Treatment of Chondral Defect in the Knee
Actual Study Start Date : September 1, 2017
Estimated Primary Completion Date : September 1, 2025
Estimated Study Completion Date : September 1, 2025

Arm Intervention/treatment
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.
Other: autologous chondrocytes
autologous chondrocytes implantation (ACI)




Primary Outcome Measures :
  1. 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).

  2. Change in tissue integrity into and around the treated aera [ Time Frame: 3 months post-implantation ]
    MRI analysis

  3. 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%.


Secondary Outcome Measures :
  1. 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).

  2. 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).

  3. 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).

  4. 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)



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Ages Eligible for Study:   15 Years to 50 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04296487


Contacts
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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

Locations
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Switzerland
Centre Hospitalier Universitaire Vaudois - CHUV Recruiting
Lausanne, Vaud, Switzerland, 1011
Contact: Robin MARTIN, MD    021 314 76 79 ext 41    robin.martin@chuv.ch   
Dr Robin MARTIN Recruiting
Lausanne, Vaud, Switzerland, 1011
Contact: Robin Martin, MD    021 314 76 79 ext 41    robin.martin@chuv.ch   
Sponsors and Collaborators
Centre Hospitalier Universitaire Vaudois
Investigators
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Principal Investigator: Robin MARTIN, MD CHUV
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Responsible Party: Dr. Robin Martin, Principal Investigator, Centre Hospitalier Universitaire Vaudois
ClinicalTrials.gov Identifier: NCT04296487    
Other Study ID Numbers: ACI-OTR
First Posted: March 5, 2020    Key Record Dates
Last Update Posted: March 6, 2020
Last Verified: March 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Osteochondritis
Bone Diseases
Musculoskeletal Diseases
Cartilage Diseases
Connective Tissue Diseases