Actively Recruiting

Phase Not Applicable
Age: 15Years - 50Years
All Genders
ID04296487

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

Age: 15Years - 50Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

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

Follow-up

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

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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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