The purpose of this study is to investigate the safety and feasibility of implanting autologous cartilage mini-grafts (or Cartibeads) into cartilage defects in the knee and ankle. Cartibeads are engineered from autologous articular chondrocytes (from the patient's own cartilage cells). A small cartilage biopsy (\~50 to 150 mg according to lesion size to be treated) is collected from a minimal weight bearing zone of the patient's articulation. Chondrocytes are extracted from the biopsy and expanded in culture. Our patented, standardized methodology then allows expanded cells to recover their capacity of producing hyaline matrix and to form cartilage mini-grafts (Cartibeads). These grafts are beads of 1 to 2 mm in diameter and have similar characteristics to native hyaline cartilage. Autologous Cartibeads are implanted into the patient's cartilage defect. Patients are then followed for 12 months for assessment of study endpoints, with safety being the primary outcome.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
11
1. st surgery: cartilage biopsy harvest by minimally invasive surgery (arthroscopy or mini arthrotomy). 2. nd surgery: Implantation of autologous 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
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 12 months
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