Cartilage RepairPhase 1NCT06897098
Regeneration of Knee and Ankle Cartilage From Autologous Cartilage Mini-grafts (From the Patient's Own Cells)
A Phase 1 study testing Implantation of autologous cartilage mini-grafts (Cartibeads) in people with Cartilage Repair, run by Vanarix SA at 3 sites in Switzerland.
Trial summary
The purpose of this study is to investigate the safety and feasibility of implanting autologous cartilage mini-grafts (or Cartibeads) into cartilage defects in the knee and ankle. Cartibeads are engineered from autologous articular chondrocytes (from the patient's own cartilage cells). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cartilage Repair
- What is being tested?
- Implantation of autologous cartilage mini-grafts (Cartibeads)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 3 sitesSwitzerland
- Study dates
- 10 Jun 2022to 2 Apr 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Cartilage focal lesion(s) ≥ 1.5 cm2 and ≤ 10 cm2
- ICRS grade 3 or 4
- Pain for 3 months or more
- Aged over 18 years
Who cannot join
- Inability to undergo MRI
- Cartilage specific surgery within 12 months from baseline
- Cartilage therapeutic injection within 3 months from baseline
- Radiologically apparent degenerative joint disease (K\&L grade >1)
- Chronic inflammatory arthritis and/or infectious arthritis
Trial locations and contacts
3 sites in 1 country.
Switzerland3 sites
Center for Sports Medicine and Exercise, Hirslanden Clinique La Colline
Geneva, Canton of Geneva, 1206
Geneva University Hospitals (HUG)
Geneva, Canton of Geneva, 1211
Ente Ospedaliero Cantonale (EOC)
Lugano, Canton Ticino, 6962
About this study
Official title: Autologous Cartilage Implantation: Safety Study for Focal Chondral Lesions in the Knee and the Ankle : Open Cohort, Small Sample Size With 12 Months Follow-Up
The purpose of this study is to investigate the safety and feasibility of implanting autologous cartilage mini-grafts (or Cartibeads) into cartilage defects in the knee and ankle.
Cartibeads are engineered from autologous articular chondrocytes (from the patient's own cartilage cells). A small cartilage biopsy (~50 to 150 mg according to lesion size to be treated) is collected from a minimal weight bearing zone of the patient's articulation. Chondrocytes are extracted from the biopsy and expanded in culture. Our patented, standardized methodology then allows expanded cells to recover their capacity of producing hyaline matrix and to form cartilage mini-grafts (Cartibeads). These grafts are beads of 1 to 2 mm in diameter and have similar characteristics to native hyaline cartilage.
Autologous Cartibeads are implanted into the patient's cartilage defect. Patients are then followed for 12 months for assessment of study endpoints, with safety being the primary outcome.
- Conditions
- Cartilage Repair
- Being tested
- Implantation of autologous cartilage mini-grafts (Cartibeads)
- Keywords
- Cartilage repair
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implantation of autologous cartilage mini-grafts (Cartibeads)Biological
- st surgery: cartilage biopsy harvest by minimally invasive surgery (arthroscopy or mini arthrotomy).
- nd surgery: Implantation of autologous cartilage mini-grafts (Cartibeads) by minimally invasive surgery (arthroscopy or mini arthrotomy). Cartibeads should entirely fill the defect zone, followed by a thin layer of surgical glue (TISSEEL Fibrin Sealant).
| Study group | Role | What they receive |
|---|---|---|
| Autologous Cartibeads | Experimental | Implantation of autologous cartilage mini-grafts (Cartibeads) Receives: Biological: Implantation of autologous cartilage mini-grafts (Cartibeads) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety
Recording, identifying, documenting and reporting all Serious Adverse Events (SAEs) and Adverse Events (AEs).
Measured: From enrolment to the end of follow-up at 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2025
- Study start10 Jun 2022
- Primary completion2 Apr 2025
- Study completion2 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cartilage RepairStudies of the same condition, open and under way.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanarix SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06897098
- Sponsor's protocol ID
- 701146
- Other IDs
- 701146 (CTI.02), 2019-01727, 52372, 000004042, 2019
- Status last verified
- Sep 2025
- First submitted
- 19 Mar 2025
- Last updated
- 11 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Autologous Cartilage Implantation: Safety Study for Focal Chondral Lesions in the Knee and the Ankle : Open Cohort, Small Sample Size With 12 Months Follow-Up
- ClinicalTrials.gov ID
- NCT06897098
- Acronym / sponsor ID
- 701146
- Conditions
- Cartilage Repair
- Keywords
- Cartilage repair
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Vanarix SAIndustry (pharma, biotech, devices)
- Study start
- 10 Jun 2022 (actual)
- Primary completion
- 2 Apr 2025 (actual)
- Study completion
- 2 Apr 2025 (actual)
- First posted
- 26 Mar 2025 (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.
The purpose of this study is to investigate the safety and feasibility of implanting autologous cartilage mini-grafts (or Cartibeads) into cartilage defects in the knee and ankle.
Cartibeads are engineered from autologous articular chondrocytes (from the patient's own cartilage cells). A small cartilage biopsy (~50 to 150 mg according to lesion size to be treated) is collected from a minimal weight bearing zone of the patient's articulation. Chondrocytes are extracted from the biopsy and expanded in culture. Our patented, standardized methodology then allows expanded cells to recover their capacity of producing hyaline matrix and to form cartilage mini-grafts (Cartibeads). These grafts are beads of 1 to 2 mm in diameter and have similar characteristics to native hyaline cartilage.
Autologous Cartibeads are implanted into the patient's cartilage defect. Patients are then followed for 12 months for assessment of study endpoints, with safety being the primary outcome.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Autologous Cartibeads | Experimental | Biological: Implantation of autologous cartilage mini-grafts (Cartibeads)Implantation of autologous cartilage mini-grafts (Cartibeads) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Cartilage focal lesion(s) ≥ 1.5 cm2 and ≤ 10 cm2
- ICRS grade 3 or 4
- Pain for 3 months or more
- Aged over 18 years
Key exclusion criteria (5 listed)
- Inability to undergo MRI
- Cartilage specific surgery within 12 months from baseline
- Cartilage therapeutic injection within 3 months from baseline
- Radiologically apparent degenerative joint disease (K\&L grade >1)
- Chronic inflammatory arthritis and/or infectious arthritis
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 |
|---|---|---|
| Implantation of autologous cartilage mini-grafts (Cartibeads)1. st surgery: cartilage biopsy harvest by minimally invasive surgery (arthroscopy or mini arthrotomy). 2. nd surgery: Implantation of autologous cartilage mini-grafts (Cartibeads) by minimally invasive surgery (arthroscopy or mini arthrotomy). Cartibeads should entirely fill the defect zone, followed by a thin layer of surgical glue (TISSEEL Fibrin Sealant). | Biological | Autologous Cartibeads |
Primary outcome
Safety
Time frame: From enrolment to the end of follow-up at 12 months
Recording, identifying, documenting and reporting all Serious Adverse Events (SAEs) and Adverse Events (AEs).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2026.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Implantation of autologous cartilage mini-grafts (Cartibeads) in people with Cartilage Repair, run by Vanarix SA at 3 sites 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 5 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: finished, as of the sponsor's last update on 11 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety (time frame: From enrolment to the end of follow-up at 12 months). 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 Aug 2026.