Actively Recruiting
Introduction of Autologous Chondrocyte Implantation Procedure for Treatment of Knee Cartilage Defects
Led by Centre Hospitalier Universitaire Vaudois · Updated on 2026-03-11
218
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate the effectiveness and safety of using a patient's own cartilage cells, called autologous chondrocytes, to treat knee cartilage defects such as articular cartilage defects, chondral defects, and osteochondritis. It is a prospective, interventional study focused on improving knee function and quality of life for patients with specific cartilage lesions that have not responded to previous treatments. The study involves taking a biopsy from the patient, growing their cartilage cells in a laboratory, and then injecting these cells at a dose of 2 million cells per square centimeter directly into the cartilage defect in the knee. After implantation, participants follow a strict rehabilitation protocol for 12 months. Follow-up visits are scheduled at 6 weeks, 3 months, 6 months, and 12 months to monitor progress and safety. Participants will undergo assessments including MRI scans evaluated by the MOCART scoring system to observe cartilage repair, as well as orthopedic evaluations using scores like KOOS, IKDC, and the SF-12 survey to measure knee function, pain, and quality of life. Safety is closely monitored by tracking serious adverse events and infections related to the implantation. The total study duration includes one year of follow-up after the cell implantation procedure.
CONDITIONS
Brief Title
Introduction of ACI for Cartilage Repair
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 15 and 50 years
- Cartilage lesions classified as ICRS Grade III or IV and smaller than 15 cm2
- Lesions that have not improved after at least six months of prior treatment
- Ability to understand and sign the study consent form
You will not qualify if you...
- Body mass index (BMI) of 35 or more
- Diagnosis of osteoarthritis or rheumatoid arthritis
- Presence of diffuse cartilage lesions
- Uncorrected mal-alignment, ligament instability, or meniscal tear
- Presence of growth cartilage in participants aged 15 to 18 years
- Active smoking or drug use
- Pregnancy
- Positive tests for HIV-1, HIV-2, Hepatitis B or C, or syphilis
- Known allergy to porcine collagen, penicillin, or gentamicin
- Poor compliance with study requirements
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 12 months
Participants undergo a biopsy to collect cartilage cells, which are then expanded in the laboratory and implanted back into the cartilage defect area of the knee. This includes a strict post-surgery rehabilitation protocol.
1 implantation visit followed by rehabilitation
Duration - 12 months post-implantation
Participants are assessed at multiple intervals post-implantation to monitor safety and effectiveness, including MRI scans and knee function assessments.
Visits at 6 weeks, 3 months, 6 months, and 12 months post-implantation
Trial Site Locations
Total: 1 location
1
Centre Hospitalier Universitaire Vaudois - CHUV
Lausanne, Canton of Vaud, Switzerland, 1011
Actively Recruiting
Research Team
R
Robin MARTIN, MD
V
Virginie PHILIPPE, Ph-D
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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