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

March 19, 2025 updated by: Vanarix SA

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Phase 2
  • 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
      • Zurich, Switzerland, 8008
        • Balgrist University Hospital (BUH)
    • 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:

  • 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

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

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 6 months
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

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 17, 2024

Primary Completion (Estimated)

July 1, 2025

Study Completion (Estimated)

July 1, 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

  • 701779 (Other Identifier: Swissmedic)
  • 2023-02168 (Other Identifier: BASEC)
  • 64935 (Other Identifier: HumRes)
  • 000005866 (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.

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