Introduction of ACI for Cartilage Repair

Centre Hospitalier Universitaire Vaudois100 enrolled

Overview

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

* 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

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

100

Conditions

Articular Cartilage Defect Chondral Defect Osteochondritis

Interventions

autologous chondrocytesOTHER

autologous chondrocytes implantation (ACI)

Eligibility

Sex: ALLMin age: 15 YearsMax age: 50 Years

Medical Language ↔ Plain English

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

Locations (1)

Centre Hospitalier Universitaire Vaudois - CHUV

Lausanne, Canton of Vaud, Switzerland

RECRUITING

Outcomes

Primary Outcomes

Rate of implantation-associated complications: serious adverse events (SAEs) and serious adverse reactions (SARs)

Post-implantation data collection: Types, probability and severity of treatment (inflammation, infection,pain, joint effusion, delamination, transplant rejection, fibrocartilage, incomplete cartilage reparation).

Time frame: Up to 12 months.

Change in tissue integrity into and around the treated aera

MRI analysis

Time frame: 3 months post-implantation

Absence of infection after 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%.

Time frame: 6 weeks post-implantation

Secondary Outcomes

Self-reported function and knee-related quality of life are assessed by using the Knee injury and Osteoarthritis Outcome Score (KOOS)

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).

Time frame: Change from baseline to 12 months post-implantation.

Self-reported physical pain and function are assessed by International Knee Documentation Committee score (IKDC)

A score will be calculated, and it ranges from 0 (worst score) to 100 (best score).

Time frame: Change from baseline to 12 months post-implantation

Self-reported functional health and weel-being as assessed by SF12 Survey

Central Contacts

Robin MARTIN, MD

CONTACT

021 314 76 79 robin.martin@chuv.ch

Virginie PHILIPPE, Ph-D

CONTACT

021 314 90 18 virginie.philippe@chuv.ch

Data from ClinicalTrials.gov

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