Regeneration of knee and ankle joint cartilage from autologous cells (from the patient's own cells)
Zusammenfassung der Studie
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)
Untersuchte Intervention
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)
Untersuchte Krankheit(en)
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)
Ausschlusskriterien
- 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)
Studienstandort
Genf, Lugano
(BASEC)
Sponsor
Vanarix SA
(BASEC)
Kontakt für weitere Auskünfte zur Studie
Kontaktperson Schweiz
Dr Vannary Tieng
+41 78 244 92 03
Vannary.Tieng@cluttervanarix-sa.chVanarix SA
(BASEC)
Wissenschaftliche Auskünfte
nicht verfügbar
Name der bewilligenden Ethikkommission (bei multizentrischen Studien nur die Leitkommission)
Ethikkommission Genf
(BASEC)
Datum der Bewilligung durch die Ethikkommission
15.09.2020
(BASEC)
ICTRP Studien-ID
NCT06897098 (ICTRP)
Offizieller Titel (Genehmigt von der Ethikkommission)
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)
Wissenschaftlicher Titel
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)
Öffentlicher Titel
Regeneration of Knee and Ankle Cartilage from Autologous Cartilage Mini-grafts (from the Patient's Own Cells) (ICTRP)
Untersuchte Krankheit(en)
Cartilage Repair (ICTRP)
Untersuchte Intervention
Biological: Implantation of autologous cartilage mini-grafts (Cartibeads) (ICTRP)
Studientyp
Interventional (ICTRP)
Studiendesign
Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label). (ICTRP)
Ein-/Ausschlusskriterien
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)
nicht verfügbar
Primäre und sekundäre Endpunkte
Safety (ICTRP)
nicht verfügbar
Registrierungsdatum
nicht verfügbar
Einschluss des ersten Teilnehmers
nicht verfügbar
Sekundäre Sponsoren
nicht verfügbar
Weitere Kontakte
nicht verfügbar
Sekundäre IDs
701146 (CTI.02), 2019-01727, 52372, 000004042, 701146 (ICTRP)
Angaben zur Verfügbarkeit von individuellen Teilnehmerdaten
nicht verfügbar
Weitere Informationen zur Studie
https://clinicaltrials.gov/ct2/show/NCT06897098 (ICTRP)
Ergebnisse der Studie
Zusammenfassung der Ergebnisse
nicht verfügbar
Link zu den Ergebnissen im Primärregister
nicht verfügbar