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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE1/PHASE2

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-17

Study Completion Date

2025-07-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

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

NCT06897098

Cartilage Repair

ACTIVE_NOT_RECRUITING PHASE1

Evaluation of Treatment of Osteoarthritis of the Knee in the Form of Chondromalacia of the Articular Cartilage Treated in the Arthroscopic Technique With the Use of:Autogenous Transplantation of Fragmented Adipose Tissue,PRP GF,Mesenchymal Cells,Hyaluronic Acid-low Molecular Weight and Cross-linked

NCT07110402

Osteoarthritis, Knee Chondral Defect Chondromalacia, Left Knee +2 more

COMPLETED NA

Autologous Chondrocyte Implantation in the Patellofemoral Joint

NCT00212849

Chondrosis Patellar Articular Cartilage Lesions Trochlear Articular Cartilage Lesions

COMPLETED

Introduction of ACI for Cartilage Repair

NCT04296487

Articular Cartilage Defect Chondral Defect Osteochondritis

UNKNOWN NA

Study on Safety, Tolerability and Prelimenary Efficacy of LNA043 in Patients Undergoing Autologous Chondrocyte Implantation

NCT03334812

Knee Cartilage Lesion

TERMINATED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cartilage Repair

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Allogeneic Cartibeads

Implantation of allogeneic cartilage mini-grafts (Allogeneic Cartibeads)

Group Type EXPERIMENTAL

Implantation of allogeneic cartilage mini-grafts (Allogeneic Cartibeads)

Intervention Type BIOLOGICAL

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).

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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).

Intervention Type BIOLOGICAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No