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ACTIVE NOT RECRUITING
NCT06897111
PHASE1/PHASE2

Implantation of Cartilage Mini-grafts Made From Donor Cells to Treat Chondral Lesions of the Knee

Sponsor: Vanarix SA

View on ClinicalTrials.gov

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). 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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

10

Start Date

2024-06-17

Completion Date

2025-07-01

Last Updated

2025-03-26

Healthy Volunteers

No

Interventions

BIOLOGICAL

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).

Locations (4)

Center for Sports Medicine and Exercise, Hirslanden Clinique La Colline

Geneva, Canton of Geneva, Switzerland

Geneva University Hospitals (HUG)

Geneva, Canton of Geneva, Switzerland

Balgrist University Hospital (BUH)

Zurich, Canton of Zurich, Switzerland

Ente Ospedaliero Cantonale (EOC)

Lugano, Canton Ticino, Switzerland