Introduction of ACI for Cartilage Repair

Vaud University Hospital Center

Status: Enrolling

Conditions: Chondral Defect; Osteochondritis; Articular Cartilage Defect

Treatments: Other: autologous chondrocytes

Study type: Interventional

Funder types: Other

Identifiers

NCT04296487

ACI-OTR

Details and patient eligibility

About

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

Full 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)

Enrollment: 100 estimated patients

Sex: All

Ages: 15 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

Autologous Chondrocyte Injection

Experimental group

Description:

Autologous chondrocytes were isolated and expanded in laboratory, then injected at 2x10\^6 of cells per cm\^2 of the cartilage defect.

Treatment:

Other: autologous chondrocytes