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

NCT06897098 | Active Not Recruiting Phase 1 DMC

• 5 other identifiers: 701146701146 (CTI.02)2019-0172752372000004042
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 3

Brief 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

Keywords

Cartilage repair

Outcome Measures

Primary Outcomes (1)

• Safety

  Recording, identifying, documenting and reporting all Serious Adverse Events (SAEs) and Adverse Events (AEs).

  From enrolment to the end of follow-up at 12 months

Study Arms (1)

Autologous Cartibeads

EXPERIMENTAL

Implantation of autologous cartilage mini-grafts (Cartibeads)

Biological: Implantation of autologous cartilage mini-grafts (Cartibeads)

Interventions

Implantation of autologous cartilage mini-grafts (Cartibeads) BIOLOGICAL

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).

Autologous Cartibeads

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Cartilage focal lesion(s) ≥ 1.5 cm2 and ≤ 10 cm2
• ICRS grade 3 or 4
• Pain for 3 months or more
• Aged over 18 years

You may not qualify if:

• Inability to undergo MRI
• Cartilage specific surgery within 12 months from baseline
• Cartilage therapeutic injection within 3 months from baseline
• Radiologically apparent degenerative joint disease (K\&L grade \>1)
• Chronic inflammatory arthritis and/or infectious arthritis

Sponsors & Collaborators

• Vanarix SA: lead

Study Sites (3)

Center for Sports Medicine and Exercise, Hirslanden Clinique La Colline

Geneva, Canton of Geneva, 1206, Switzerland

Location

Geneva University Hospitals (HUG)

Geneva, Canton of Geneva, 1211, Switzerland

Location

Ente Ospedaliero Cantonale (EOC)

Lugano, Canton Ticino, 6962, Switzerland

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 19, 2025
• First Posted: March 26, 2025
• Study Start: June 10, 2022
• Primary Completion: April 2, 2025
• Study Completion: April 2, 2025
• Last Updated: March 26, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CH (3)