ClinicalTrials.gg
RecruitingNCT04296487Updated Mar 11, 2026

Introduction of ACI for Cartilage Repair

An interventional study of autologous chondrocytes in Articular Cartilage Defect, Chondral Defect and Osteochondritis, sponsored by Centre Hospitalier Universitaire Vaudois. Recruiting at 1 site in Switzerland. Open to participants aged 15 Years to 50 Years. Per ClinicalTrials.gov, last updated 2026-03-11.

Sponsored by Centre Hospitalier Universitaire Vaudois · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 11 months after the study started (first participant enrolled Sep 2017, registered Aug 2019).
  • Started Sep 2017; still recruiting 9 years 2 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
218
Allocation
Not applicable
Ages
15 Years to 50 Years
Sex
All
01

Study summary

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

Read the 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)
02

Conditions studied

  • Articular Cartilage Defect
  • Chondral Defect
  • Osteochondritis

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03

In context

Osteochondritis

5 studies on the registry are indexed under Osteochondritis; 3 are open to participants now.

Browse Osteochondritis studies →

Lead sponsor

Centre Hospitalier Universitaire Vaudois is the lead sponsor of 208 studies on the registry; 48 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
15 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  1. (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 -1 or HIV-2, and C and syphilis
  9. Proven allergy to porcine collagen, penicillin and gentamicin
  10. Poor compliance
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
218 participants (estimated)

Study arms

  • 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

Interventions

  • Otherautologous chondrocytes

    autologous chondrocytes implantation (ACI)

06

What researchers measure

Primary outcomes

  1. 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).

    Time frame: Up to 12 months.

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

    MRI analysis

    Time frame: 3 months post-implantation

  3. 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%.

    Time frame: 6 weeks post-implantation

Secondary outcomes

  1. 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).

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

  2. 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).

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

  3. 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).

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

  4. 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)

    Time frame: Change from baseline to12 months post-implantation

07

Study locations

1 of 1 sites recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Sep 2017 (actual). Primary completion is estimated for Sep 2030, 156 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 1, 2019
First posted
Mar 5, 2020
StartActual
Sep 1, 2017
Primary completionEst.
Sep 2030
CompletionEst.
Sep 2030
Last update
Mar 11, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 11, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04296487
Responsible party
Dr. Robin Martin (Principal Investigator, Centre Hospitalier Universitaire Vaudois) — Principal investigator
First posted
Mar 5, 2020
Start date
Sep 1, 2017
Primary completion
Sep 2030 (estimated)
Completion
Sep 2030 (estimated)
Last update
Mar 11, 2026

Study contacts

Robin MARTIN, MD
Contact
robin.martin@chuv.ch
021 314 76 79 ext. 41
Virginie PHILIPPE, Ph-D
Contact
virginie.philippe@chuv.ch
021 314 90 18 ext. 41
Robin MARTIN, MD
principal investigator · CHUV

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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