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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06897098

Enrollment

Registered

2025-03-26

Start date

2022-06-10

Completion date

2025-04-02

Last updated

2026-08-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cartilage Repair

Keywords

Cartilage repair

Brief summary

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.

Interventions

BIOLOGICALImplantation 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).

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

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

Design outcomes

Primary

Measure	Time frame	Description
Safety	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).

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 12, 2026