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| ID | Type | Description | Link |
|---|---|---|---|
| 701779 | Other Identifier | Swissmedic | |
| 2023-02168 | Other Identifier | BASEC | |
| 64935 | Other Identifier | HumRes | |
| 000005866 | Other Identifier | SNCTP |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Allogeneic Cartibeads | Experimental | Implantation of allogeneic cartilage mini-grafts (Allogeneic Cartibeads) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Safety | Recording, identifying, documenting and reporting all Serious Adverse Events (SAEs) and Adverse Events (AEs). | From enrolment to the end of follow-up at 6 months |
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Key inclusion criteria:
Key exclusion criteria
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for Sports Medicine and Exercise, Hirslanden Clinique La Colline | Geneva | Canton of Geneva | 1206 | Switzerland | ||
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| Geneva University Hospitals (HUG) |
| Geneva |
| Canton of Geneva |
| 1211 |
| Switzerland |
| Balgrist University Hospital (BUH) | Zurich | Canton of Zurich | 8008 | Switzerland |
| Ente Ospedaliero Cantonale (EOC) | Lugano | Canton Ticino | 6962 | Switzerland |