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

March 19, 2025 updated by: Vanarix SA

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

11

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Geneva, Switzerland, 1211
        • Geneva University Hospitals (HUG)
      • Geneva, Switzerland, 1206
        • Center for Sports Medicine and Exercise, Hirslanden Clinique La Colline
    • Ticino
      • Lugano, Ticino, Switzerland, 6962
        • Ente Ospedaliero Cantonale (EOC)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Autologous Cartibeads
Implantation of autologous cartilage mini-grafts (Cartibeads)
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
From enrolment to the end of follow-up at 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vanarix SA

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 10, 2022

Primary Completion (Estimated)

April 2, 2025

Study Completion (Estimated)

April 2, 2025

Study Registration Dates

First Submitted

March 19, 2025

First Submitted That Met QC Criteria

March 19, 2025

First Posted (Actual)

March 26, 2025

Study Record Updates

Last Update Posted (Actual)

March 26, 2025

Last Update Submitted That Met QC Criteria

March 19, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 701146
  • 701146 (CTI.02) (Other Identifier: Swissmedic)
  • 2019-01727 (Other Identifier: BASEC)
  • 52372 (Other Identifier: HumRes)
  • 000004042 (Other Identifier: SNCTP)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cartilage Repair

Clinical Trials on Implantation of autologous cartilage mini-grafts (Cartibeads)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Colombia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe