Cartilage RepairPhase 1/2NCT06897111
Implantation of Cartilage Mini-grafts Made From Donor Cells to Treat Chondral Lesions of the Knee
A Phase 1/2 study testing Implantation of allogeneic cartilage mini-grafts (Allogeneic Cartibeads) in people with Cartilage Repair, run by Vanarix SA at 4 sites in Switzerland.
Trial summary
The purpose of this study is to investigate the safety and feasibility of implanting allogeneic cartilage mini-grafts (or allogenic Cartibeads) into cartilage defects in the knee. Allogeneic Cartibeads are engineered from allogeneic articular chondrocytes (from a donor's 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 allogeneic cartilage mini-grafts (Allogeneic Cartibeads)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 4 sitesSwitzerland
- Study dates
- 17 Jun 2024to 17 Jun 2025
- Phase
- Phase 1/2
- 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
- Symptomatic cartilage lesion(s) of the femorotibial and/or patellofemoral compartments (includes isolated, multiple and kissing lesions)
- Cartilage lesion(s) ≥ 1 cm2 and ≤ 10 cm2
- ICRS grade 3 or 4
- Aged over 18 years
Who cannot join
- Inability to undergo MRI
- Cartilage specific surgery within 6 months from baseline
- Cartilage therapeutic injection within 3 months from baseline
- Chronic inflammatory arthritis and/or infectious arthritis
Trial locations and contacts
4 sites in 1 country.
Switzerland4 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
Balgrist University Hospital (BUH)
Zurich, Canton of Zurich, 8008
About this study
Official title: Implantation of Allogenic Cartilage Mini-grafts: First-In-Human Study for Treating Chondral Lesions of the Knee. Open Cohort, Small Sample Size With 6 Months Follow-Up
The purpose of this study is to investigate the safety and feasibility of implanting allogeneic cartilage mini-grafts (or allogenic Cartibeads) into cartilage defects in the knee.
Allogeneic Cartibeads are engineered from allogeneic articular chondrocytes (from a donor's cartilage cells). The donor, who in 2022 participated in the Autologous Cartibeads clinical trial (Swissmedic ID 701146), consented to use his leftover cells for production of mini-grafts for other patients in this study. Our patented, standardized methodology allows production of bead-shaped mini-grafts (Allogeneic Cartibeads). These grafts are 1 to 2 mm in diameter and have similar characteristics to native hyaline cartilage.
Allogeneic Cartibeads are implanted into the patient's cartilage defect. Patients are then followed for 6 months for assessment of study endpoints, with safety being the primary outcome.
- Conditions
- Cartilage Repair
- Being tested
- Implantation of allogeneic cartilage mini-grafts (Allogeneic 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 allogeneic cartilage mini-grafts (Allogeneic Cartibeads)Biological
Implantation of allogeneic 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 |
|---|---|---|
| Allogeneic Cartibeads | Experimental | Implantation of allogeneic cartilage mini-grafts (Allogeneic Cartibeads) Receives: Biological: Implantation of allogeneic cartilage mini-grafts (Allogeneic 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 6 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 start17 Jun 2024
- Primary completion1 Feb 2025
- Study completion17 Jun 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 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
- NCT06897111
- Sponsor's protocol ID
- 701779
- Other IDs
- 701779, 2023-02168, 64935, 000005866, 2023
- Status last verified
- Sep 2025
- First submitted
- 19 Mar 2025
- Last updated
- 24 Sep 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 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implantation of Allogenic Cartilage Mini-grafts: First-In-Human Study for Treating Chondral Lesions of the Knee. Open Cohort, Small Sample Size With 6 Months Follow-Up
- ClinicalTrials.gov ID
- NCT06897111
- Acronym / sponsor ID
- 701779
- Conditions
- Cartilage Repair
- Keywords
- Cartilage repair
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Vanarix SAIndustry (pharma, biotech, devices)
- Study start
- 17 Jun 2024 (actual)
- Primary completion
- 1 Feb 2025 (actual)
- Study completion
- 17 Jun 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 allogeneic cartilage mini-grafts (or allogenic Cartibeads) into cartilage defects in the knee.
Allogeneic Cartibeads are engineered from allogeneic articular chondrocytes (from a donor's cartilage cells). The donor, who in 2022 participated in the Autologous Cartibeads clinical trial (Swissmedic ID 701146), consented to use his leftover cells for production of mini-grafts for other patients in this study. Our patented, standardized methodology allows production of bead-shaped mini-grafts (Allogeneic Cartibeads). These grafts are 1 to 2 mm in diameter and have similar characteristics to native hyaline cartilage.
Allogeneic Cartibeads are implanted into the patient's cartilage defect. Patients are then followed for 6 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 |
|---|---|---|
| Allogeneic Cartibeads | Experimental | Biological: Implantation of allogeneic cartilage mini-grafts (Allogeneic Cartibeads)Implantation of allogeneic cartilage mini-grafts (Allogeneic 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)
- Symptomatic cartilage lesion(s) of the femorotibial and/or patellofemoral compartments (includes isolated, multiple and kissing lesions)
- Cartilage lesion(s) ≥ 1 cm2 and ≤ 10 cm2
- ICRS grade 3 or 4
- Aged over 18 years
Key exclusion criteria (4 listed)
- Inability to undergo MRI
- Cartilage specific surgery within 6 months from baseline
- Cartilage therapeutic injection within 3 months from baseline
- 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 allogeneic cartilage mini-grafts (Allogeneic Cartibeads)Implantation of allogeneic 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 | Allogeneic Cartibeads |
Primary outcome
Safety
Time frame: From enrolment to the end of follow-up at 6 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 24 Sep 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.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Implantation of allogeneic cartilage mini-grafts (Allogeneic Cartibeads) in people with Cartilage Repair, run by Vanarix SA at 4 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 4 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 24 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 6 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 24 Sep 2026.