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

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

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.

Key inclusion criteria:

• Symptomatic cartilage lesion(s) of the femorotibial and/or patellofemoral compartments (includes isolated, multiple and kissing lesions)
• Cartilage lesion(s) ≥ 1 cm2 and ≤ 10 cm2
• ICRS grade 3 or 4
• Aged over 18 years

Key exclusion criteria

• Inability to undergo MRI
• Cartilage specific surgery within 6 months from baseline
• Cartilage therapeutic injection within 3 months from baseline
• Chronic inflammatory arthritis and/or infectious arthritis