NCT06897098

Regeneration of Knee and Ankle Cartilage From Autologous Cartilage Mini-grafts (From the Patient's Own Cells)

Autologous Cartilage Implantation: Safety Study for Focal Chondral Lesions in the Knee and the Ankle : Open Cohort, Small Sample Size With 12 Months Follow-Up

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: Vanarix SA · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Cartilage Repair

Interventions

Type	Name	Description
BIOLOGICAL	Implantation of autologous cartilage mini-grafts (Cartibeads)	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).

Timeline

• Start date: 2022-06-10
• Primary completion: 2025-04-02
• Completion: 2025-04-02
• First posted: 2025-03-26
• Last updated: 2025-03-26

Locations

3 sites across 1 country: Switzerland