Introduction of ACI for Cartilage Repair

Not Applicable

Recruiting

• Conditions: Articular Cartilage Defect; Chondral Defect; Osteochondritis
• Interventions: Other: autologous chondrocytes

• Registration Number: NCT04296487
• Lead Sponsor: 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.

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)

Study Timeline

• Study Start: 2017-09-01
• Study First Submitted: 2019-08-01
• Study First Submitted QC: 2020-03-04
• Study First Posted: 2020-03-05
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-07
• Last Update Posted: 2022-12-08
• Primary Completion: 2025-09-01
• Study Completion: 2025-09-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Change in tissue integrity into and around the treated aera	3 months post-implantation	MRI analysis
Rate of implantation-associated complications: serious adverse events (SAEs) and serious adverse reactions (SARs)	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).
Absence of infection after implantation.	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

Name	Time	Method
Self-reported function and knee-related quality of life are assessed by using the Knee injury and Osteoarthritis Outcome Score (KOOS)	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).
Self-reported physical pain and function are assessed by International Knee Documentation Committee score (IKDC)	Change from baseline to 12 months post-implantation	A score will be calculated, and it ranges from 0 (worst score) to 100 (best score).
Self-reported functional health and weel-being as assessed by SF12 Survey	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).
The cartilage repair is assesed by Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) scoring system.	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)

Trial Locations

Locations (1)

Centre Hospitalier Universitaire Vaudois - CHUV; 🇨🇭 Lausanne, Vaud, Switzerland