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

NCT06897111 | Active Not Recruiting Phase 1 DMC

• 4 other identifiers: 7017792023-0216864935000005866
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 4

Brief Summary

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.

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 6 months

Study Arms (1)

Allogeneic Cartibeads

EXPERIMENTAL

Implantation of allogeneic cartilage mini-grafts (Allogeneic Cartibeads)

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

Interventions

Implantation of allogeneic cartilage mini-grafts (Allogeneic Cartibeads) BIOLOGICAL

Implantation of allogeneic 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).

Allogeneic Cartibeads

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Vanarix SA: lead

Study Sites (4)

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

Balgrist University Hospital (BUH)

Zurich, Canton of Zurich, 8008, 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 17, 2024
• Primary Completion: July 1, 2025
• Study Completion: July 1, 2025
• Last Updated: March 26, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CH (4)