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NCT Number: NCT04296487

Introduction of ACI for Cartilage Repair

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

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Key information

Conditions

Articular Cartilage Defect Bone Diseases Cartilage Diseases Chondral Defect Connective Tissue Diseases Musculoskeletal Diseases Osteochondritis Skin and Connective Tissue Diseases

Age range

15 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Hospitalier Universitaire Vaudois - CHUV

Lausanne, Canton of Vaud, 1011, Switzerland

Location status: Recruiting

Location contact

Robin MARTIN, MD

CONTACT

[email protected]

021 314 76 79 ext. 41

About this study

  • 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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

autologous chondrocytes

Other

autologous chondrocytes implantation (ACI)

Primary outcomes

  1. Rate of implantation-associated complications: serious adverse events (SAEs) and serious adverse reactions (SARs)

    Time frame: 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).

  2. Change in tissue integrity into and around the treated aera

    Time frame: 3 months post-implantation

    MRI analysis

  3. Absence of infection after implantation.

    Time frame: 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 outcomes

  1. Self-reported function and knee-related quality of life are assessed by using the Knee injury and Osteoarthritis Outcome Score (KOOS)

    Time frame: 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).

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

    Time frame: Change from baseline to 12 months post-implantation

    A score will be calculated, and it ranges from 0 (worst score) to 100 (best score).

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

    Time frame: 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).

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

    Time frame: 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)

Study contacts

Contact information is provided by the study sponsor or research team.

Robin MARTIN, MD

CONTACT

[email protected]

021 314 76 79 ext. 41

Virginie PHILIPPE, Ph-D

CONTACT

[email protected]

021 314 90 18 ext. 41

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire Vaudois

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2030
Study completion
2030
First posted
Mar 5, 2020
Registry last updated
Mar 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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