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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
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).
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
Safety
Recording, identifying, documenting and reporting all Serious Adverse Events (SAEs) and Adverse Events (AEs).
Time frame: From enrolment to the end of follow-up at 6 months
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