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

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

Status

Active, not recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06897111

Enrollment

Registered

2025-03-26

Start date

2024-06-17

Completion date

2025-07-01

Last updated

2025-03-26

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 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.

Interventions

BIOLOGICALImplantation 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).

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: * 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

Design outcomes

Primary

Measure	Time frame	Description
Safety	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).

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026