Introduction of ACI for Cartilage Repair

Articular Cartilage Defect Clinical Trial

Official title:

Introduction of Autologous Chondrocyte Implantation Procedure for the Treatment of Chondral Defect in the Knee

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04296487
• Other study ID #: ACI-OTR
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2017
• Est. completion date: September 1, 2025

Study information

• Verified date: December 2022
• Source: Centre Hospitalier Universitaire Vaudois
• Contact: Robin MARTIN, MD
• Phone: 021 314 76 79
• Email: robin.martin[@]chuv.ch
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: September 1, 2025
• Est. primary completion date: September 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Articular Cartilage Defect
• Chondral Defect
• Osteochondritis

Intervention

Other:
• autologous chondrocytes
autologous chondrocytes implantation (ACI)

Locations

Country	Name	City	State
Switzerland	Centre Hospitalier Universitaire Vaudois - CHUV	Lausanne	Vaud

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire Vaudois

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	Up to 12 months.
Primary	Change in tissue integrity into and around the treated aera	MRI analysis	3 months post-implantation
Primary	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%.	6 weeks post-implantation
Secondary	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).	Change from baseline to 12 months post-implantation.
Secondary	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).	Change from baseline to 12 months post-implantation
Secondary	Self-reported functional health and weel-being as assessed by SF12 Survey	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).	Change from baseline to 12 months post-implantation
Secondary	The cartilage repair is assesed by Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) scoring system.	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)	Change from baseline to12 months post-implantation