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

Vanarix SA

Status and phase: Active, not recruiting; Phase 2; Phase 1

Conditions: Cartilage Repair

Treatments: Biological: Implantation of allogeneic cartilage mini-grafts (Allogeneic Cartibeads)

Study type: Interventional

Funder types: Industry

Identifiers

NCT06897111

000005866 (Other Identifier)

64935 (Other Identifier)

2023-02168 (Other Identifier)

701779 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 10 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Allogeneic Cartibeads

Experimental group

Description:

Implantation of allogeneic cartilage mini-grafts (Allogeneic Cartibeads)

Treatment:

Biological: Implantation of allogeneic cartilage mini-grafts (Allogeneic Cartibeads)