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Implantation of Cartilage Mini-grafts Made From Donor Cells to Treat Chondral Lesions of the Knee
Sponsor: Vanarix SA
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
Conditions
Interventions
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