Introduction of ACI for Cartilage Repair

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

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

Study Overview

• Status: Recruiting
• Conditions: Chondral Defect; Articular Cartilage Defect; Osteochondritis
• Intervention / Treatment: Other: autologous chondrocytes

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 Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Robin Martin, MD; Phone Number: 41 021 314 76 79; Email: robin.martin@chuv.ch
• Study Contact Backup: Name: Virginie PHILIPPE, Ph-D; Phone Number: 41 021 314 90 18; Email: virginie.philippe@chuv.ch

Study Locations

• Switzerland
  • Vaud
    • Lausanne, Vaud, Switzerland, 1011
      • Recruiting
      • Centre hospitalier universitaire vaudois - CHUV
      • Contact: Robin Martin, MD; Phone Number: 41 021 314 76 79; Email: robin.martin@chuv.ch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 50 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Autologous Chondrocyte Injection; Autologous chondrocytes were isolated and expanded in laboratory, then injected at 2x10^6 of cells per cm^2 of the cartilage defect.	Other: autologous chondrocytes; autologous chondrocytes implantation (ACI)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
Change in tissue integrity into and around the treated aera	MRI analysis	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%.	6 weeks post-implantation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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
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
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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire Vaudois
• Investigators: Principal Investigator: Robin MARTIN, MD, CHUV

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2017
• Primary Completion (Anticipated): September 1, 2025
• Study Completion (Anticipated): September 1, 2025

Study Registration Dates

• First Submitted: August 1, 2019
• First Submitted That Met QC Criteria: March 4, 2020
• First Posted (Actual): March 5, 2020

Study Record Updates

• Last Update Posted (Estimate): December 8, 2022
• Last Update Submitted That Met QC Criteria: December 7, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Connective Tissue Diseases; Bone Diseases; Cartilage Diseases; Osteochondritis
• Other Study ID Numbers: ACI-OTR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No