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NCT Number: NCT06897098

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

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.

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

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:

  • 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

Key exclusion criteria

  • 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

Treatment and study plan

Implantation of autologous cartilage mini-grafts (Cartibeads)

Biological
  • st surgery: cartilage biopsy harvest by minimally invasive surgery (arthroscopy or mini arthrotomy).
  • 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).

Primary outcomes

  1. Safety

    Time frame: From enrolment to the end of follow-up at 12 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

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

Important dates

Study start
2022
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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