Articular Cartilage DefectNCT04296487
Introduction of ACI for Cartilage Repair
A study testing autologous chondrocytes in people with Articular Cartilage Defect and Chondral Defect, run by Centre Hospitalier Universitaire Vaudois at 1 site in Switzerland.
Trial summary
This study was aimed to evaluate effectiveness and safety of autologous chondrocyte suspension for treatment of knee articular cartilage defects. Read more about this study
- Who is it for?
- Ages 15 to 50 years
- Conditions the study is for
- Articular Cartilage Defect, Chondral Defect, Osteochondritis
- What is being tested?
- autologous chondrocytes
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 218 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Sep 2017to Sep 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 50 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
Centre Hospitalier Universitaire Vaudois - CHUV
Lausanne, Canton of Vaud, 1011
Robin MARTIN, MD, 021 314 76 79 ext. 41, robin.martin@chuv.ch
About this study
Official title: 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.
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)
- Conditions
- Articular Cartilage Defect, Chondral Defect, Osteochondritis
- Being tested
- autologous chondrocytes
- Medical subject headings
- Osteochondritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
autologous chondrocytesOther
autologous chondrocytes implantation (ACI)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: autologous chondrocytes |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Up to 12 months.
Change in tissue integrity into and around the treated aera
MRI analysis
Measured: 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%.
Measured: 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)
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).
Measured: 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).
Measured: 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).
Measured: 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)
Measured: Change from baseline to12 months post-implantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2020
- Study start1 Sep 2017
- Primary completionSep 2030 (estimated)
- Study completionSep 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Articular Cartilage DefectStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire VaudoisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 218 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Vaudois
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Robin Martin, Centre Hospitalier Universitaire Vaudois
- Investigators
- Robin MARTIN, MD, Principal investigator, CHUV
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04296487
- Sponsor's protocol ID
- ACI-OTR
- Status last verified
- Mar 2026
- First submitted
- 1 Aug 2019
- Last updated
- 11 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Introduction of Autologous Chondrocyte Implantation Procedure for the Treatment of Chondral Defect in the Knee
- ClinicalTrials.gov ID
- NCT04296487
- Acronym / sponsor ID
- ACI-OTR
- Conditions
- Articular Cartilage Defect, Chondral Defect, Osteochondritis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 218 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire VaudoisUniversity, hospital or other
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- Sep 2030 (estimated)
- Study completion
- Sep 2030 (estimated)
- First posted
- 5 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Autologous Chondrocyte Injection | Experimental | Other: autologous chondrocytesAutologous chondrocytes were isolated and expanded in laboratory, then injected at 2x10^6 of cells per cm^2 of the cartilage defect. |
Who may qualify
- Ages
- 15 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (10 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| autologous chondrocytesautologous chondrocytes implantation (ACI) | Other | Autologous Chondrocyte Injection |
Primary outcome
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).
Change in tissue integrity into and around the treated aera
Time frame: 3 months post-implantation
MRI analysis
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%.
4 secondary outcomes
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.
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
Self-reported functional health and weel-being as assessed by SF12 Survey
Time frame: Change from baseline to 12 months post-implantation
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Robin MARTIN, MD principal investigator
CHUV
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing autologous chondrocytes in people with Articular Cartilage Defect and Chondral Defect, run by Centre Hospitalier Universitaire Vaudois at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Robin MARTIN, MD (021 314 76 79 ext. 41, robin.martin@chuv.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of implantation-associated complications: serious adverse events (SAEs) and serious adverse reactions (SARs) (time frame: Up to 12 months.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2026.