Regeneration of knee and ankle joint cartilage from autologous cells (from the patient's own cells)
Résumé de l'étude
General information about the project The study consists of 3 phases: - Collection of a small cartilage sample - Sending the sample to the laboratory (clean room) to extract the cartilage cells (chondrocytes), culture them, and produce the mini-grafts of cartilage (Cartibeads) using a patented innovative technique (duration 7-8 weeks, variable depending on patients) - Transplantation of the grafts into the cartilage lesions through a new minimally invasive surgery This study plans to recruit 10 patients suffering from ankle/knee cartilage lesions. Each recruited patient will be followed for a period of one year after the implantation of the grafts to ensure the absence of adverse effects. The follow-up will also allow for the evaluation of the success of the implantation. An extension of the follow-up will be offered to each patient who wishes it at 2 years, 5 years, and 10 years after the implantation of the grafts. This follow-up extension will be part of another clinical study for which a new consent document will be submitted to patients who wish to participate, in due course. This project is carried out in compliance with the provisions of Swiss legislation. The competent cantonal ethics commission has reviewed and authorized this clinical study as well as the Swiss Agency for Therapeutic Products (Swissmedic).
(BASEC)
Intervention étudiée
In this study, the proposed cartilage is generated from the patient's own cells. It is developed in the laboratory over 7 to 8 weeks and appears as small cartilage grafts with a diameter of 1 to 2 mm (called cartilage microtissues or Cartibeads), minimally invasively transplantable, with characteristics similar to those of native hyaline cartilage.
(BASEC)
Maladie en cours d'investigation
cartilage lesions of the knee and ankle
(BASEC)
- Limited cartilage lesion ≥ 1.5 cm2 and ≤ 10 cm2 - Aged over 18 years - Patient consent (signed informed consent) (BASEC)
Critères d'exclusion
- Pregnant women, those who are breastfeeding, or those not using contraception - The investigator or any sub-investigator, research assistant, study coordinator, other staff member directly involved in conducting the protocol, or a relative/spouse of these persons. - Known alcoholism, illicit drug abuse • Target joint : - Degenerative joint disease with radiological appearance - Specific cartilage surgery within 12 months prior to the start of the study - Therapeutic injection of cartilage (hyaluronic acid, corticosteroid) within 3 months prior to the start of the study • Medical history : - Patients with multiple health disorders (renal, hepatic, or cardiac insufficiency) - Treated or ongoing cancer - Chronic inflammatory arthritis and/or infectious arthritis (BASEC)
Lieu de l’étude
Genève, Lugano
(BASEC)
Sponsor
Vanarix SA
(BASEC)
Contact pour plus d'informations sur l'étude
Personne de contact en Suisse
Dr Vannary Tieng
+41 78 244 92 03
Vannary.Tieng@cluttervanarix-sa.chVanarix SA
(BASEC)
Informations scientifiques
non disponible
Nom du comité d'éthique approbateur (pour les études multicentriques, uniquement le comité principal)
Commission cantonale d'éthique de Genève
(BASEC)
Date d'approbation du comité d'éthique
15.09.2020
(BASEC)
Identifiant de l'essai ICTRP
NCT06897098 (ICTRP)
Titre officiel (approuvé par le comité d'éthique)
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 (BASEC)
Titre académique
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 (ICTRP)
Titre public
Regeneration of Knee and Ankle Cartilage from Autologous Cartilage Mini-grafts (from the Patient's Own Cells) (ICTRP)
Maladie en cours d'investigation
Cartilage Repair (ICTRP)
Intervention étudiée
Biological: Implantation of autologous cartilage mini-grafts (Cartibeads) (ICTRP)
Type d'essai
Interventional (ICTRP)
Plan de l'étude
Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label). (ICTRP)
Critères d'inclusion/exclusion
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 (ICTRP)
non disponible
Critères d'évaluation principaux et secondaires
Safety (ICTRP)
non disponible
Date d'enregistrement
non disponible
Inclusion du premier participant
non disponible
Sponsors secondaires
non disponible
Contacts supplémentaires
non disponible
ID secondaires
701146 (CTI.02), 2019-01727, 52372, 000004042, 701146 (ICTRP)
Résultats-Données individuelles des participants
non disponible
Informations complémentaires sur l'essai
https://clinicaltrials.gov/ct2/show/NCT06897098 (ICTRP)
Résultats de l'essai
Résumé des résultats
non disponible
Lien vers les résultats dans le registre primaire
non disponible