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NCT Number: NCT06897111

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Cartilage Repair

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Ente Ospedaliero Cantonale (EOC), Lugano, Canton Ticino, Switzerland

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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).

Primary outcomes

  1. Safety

    Time frame: From enrolment to the end of follow-up at 6 months

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

Sponsors and collaborators

Lead sponsor

Vanarix SA

Industry

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Mar 26, 2025
Registry last updated
Mar 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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