search
Back to results

Introduction of ACI for Cartilage Repair

Primary Purpose

Articular Cartilage Defect, Chondral Defect, Osteochondritis

Status
Recruiting
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
autologous chondrocytes
Sponsored by
Centre Hospitalier Universitaire Vaudois
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Articular Cartilage Defect

Eligibility Criteria

15 Years - 50 Years (Child, Adult)All SexesDoes not accept 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

Sites / Locations

  • Centre Hospitalier Universitaire Vaudois - CHUVRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Autologous Chondrocyte Injection

Arm Description

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

Outcomes

Primary Outcome Measures

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).
Change in tissue integrity into and around the treated aera
MRI analysis
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%.

Secondary Outcome Measures

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).
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).
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).
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)

Full Information

First Posted
August 1, 2019
Last Updated
December 7, 2022
Sponsor
Centre Hospitalier Universitaire Vaudois
search

1. Study Identification

Unique Protocol Identification Number
NCT04296487
Brief Title
Introduction of ACI for Cartilage Repair
Official Title
Introduction of Autologous Chondrocyte Implantation Procedure for the Treatment of Chondral Defect in the Knee
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2017 (Actual)
Primary Completion Date
September 1, 2025 (Anticipated)
Study Completion Date
September 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centre Hospitalier Universitaire Vaudois

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Articular Cartilage Defect, Chondral Defect, Osteochondritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Autologous Chondrocyte Injection
Arm Type
Experimental
Arm Description
Autologous chondrocytes were isolated and expanded in laboratory, then injected at 2x10^6 of cells per cm^2 of the cartilage defect.
Intervention Type
Other
Intervention Name(s)
autologous chondrocytes
Intervention Description
autologous chondrocytes implantation (ACI)
Primary Outcome Measure Information:
Title
Rate of implantation-associated complications: serious adverse events (SAEs) and serious adverse reactions (SARs)
Description
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.
Title
Change in tissue integrity into and around the treated aera
Description
MRI analysis
Time Frame
3 months post-implantation
Title
Absence of infection after implantation.
Description
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 Outcome Measure Information:
Title
Self-reported function and knee-related quality of life are assessed by using the Knee injury and Osteoarthritis Outcome Score (KOOS)
Description
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.
Title
Self-reported physical pain and function are assessed by International Knee Documentation Committee score (IKDC)
Description
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
Title
Self-reported functional health and weel-being as assessed by SF12 Survey
Description
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).
Time Frame
Change from baseline to 12 months post-implantation
Title
The cartilage repair is assesed by Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) scoring system.
Description
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)
Time Frame
Change from baseline to12 months post-implantation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age between 15 and 50. Lesions classified as ICRS Grade III or IV and smaller than 15 cm2 Lesions that have failed prior therapy (conservative or surgical treatment ≥ six months) Subjects who understand and sign the consent form for this study Exclusion Criteria: Body mass index (BMI) of 35 or more Osteoarthritis or rheumatoid arthritis Diffuse lesion Uncorrected mal-alignment, ligamentous instability, or meniscal tear Presence of growth cartilage (15-18 years old) Active smoking or drug consumption Women who are pregnant Positive serology for HIV-1 or HIV-2, Hepatitis B and C and syphilis Proven allergy to porcine collagen, penicillin and gentamicin Poor compliance
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Robin MARTIN, MD
Phone
021 314 76 79
Ext
41
Email
robin.martin@chuv.ch
First Name & Middle Initial & Last Name or Official Title & Degree
Virginie PHILIPPE, Ph-D
Phone
021 314 90 18
Ext
41
Email
virginie.philippe@chuv.ch
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robin MARTIN, MD
Organizational Affiliation
CHUV
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Hospitalier Universitaire Vaudois - CHUV
City
Lausanne
State/Province
Vaud
ZIP/Postal Code
1011
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Robin MARTIN, MD
Phone
021 314 76 79
Ext
41
Email
robin.martin@chuv.ch

12. IPD Sharing Statement

Learn more about this trial

Introduction of ACI for Cartilage Repair

We'll reach out to this number within 24 hrs