NCT04296487

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
218

participants targeted

Target at P75+ for not_applicable

Timeline
52mo left

Started Sep 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress67%
Sep 2017Sep 2030

Study Start

First participant enrolled

September 1, 2017

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

August 1, 2019

Completed
7 months until next milestone

First Posted

Study publicly available on registry

March 5, 2020

Completed
10.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2030

Last Updated

March 11, 2026

Status Verified

March 1, 2026

Enrollment Period

13 years

First QC Date

August 1, 2019

Last Update Submit

March 10, 2026

Conditions

Articular Cartilage DefectChondral DefectOsteochondritis

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (4)

  • 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.

  • Self-reported physical pain and function are assessed by International Knee Documentation Committee score (IKDC)

    Change from baseline to 12 months post-implantation

  • Self-reported functional health and weel-being as assessed by SF12 Survey

    Change from baseline to 12 months post-implantation

  • The cartilage repair is assesed by Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) scoring system.

    Change from baseline to12 months post-implantation

Study Arms (1)

Autologous Chondrocyte Injection

EXPERIMENTAL

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

Interventions

autologous chondrocytesOTHER

autologous chondrocytes implantation (ACI)

Autologous Chondrocyte Injection

Eligibility Criteria

Age15 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier Universitaire Vaudois - CHUV

Lausanne, Canton of Vaud, 1011, Switzerland

RECRUITING

MeSH Terms

Conditions

Osteochondritis

Condition Hierarchy (Ancestors)

Bone DiseasesMusculoskeletal DiseasesCartilage DiseasesConnective Tissue DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Robin MARTIN, MD

    CHUV

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Robin MARTIN, MD

CONTACT

021 314 76 79robin.martin@chuv.ch

Virginie PHILIPPE, Ph-D

CONTACT

021 314 90 18virginie.philippe@chuv.ch

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 1, 2019

First Posted

March 5, 2020

Study Start

September 1, 2017

Primary Completion (Estimated)

September 1, 2030

Study Completion (Estimated)

September 1, 2030

Last Updated

March 11, 2026

Record last verified: 2026-03

Locations

CH(1)