Implantation of mini cartilage grafts made from donor cells: first study in humans to treat chondral lesions of the knee
Résumé de l'étude
The aim of this study is to demonstrate that chondral lesions can be safely treated with mini cartilage grafts, resembling beads approximately 1.5 mm in diameter, called "Cartibeads." The Cartibeads are tissue beads manufactured in the laboratory from cells (chondrocytes) extracted from a donor's cartilage. They will be deposited into the lesion(s) for treatment. A phase I clinical study in humans (safety evaluation) began in Switzerland in 2022 and is expected to conclude by the end of 2023 with a total recruitment of 10 patients. In this study, patients receive an autologous graft of Cartibeads, meaning they are made from a prior sample of their own cartilage. This study thus includes two interventions for the patient, one for the sampling and a second, 8 weeks later, for the implantation. The current study uses so-called allogeneic Cartibeads, meaning produced from a donor, and requires only a single operation. This study is the first attempt at allogeneic Cartibead grafting in humans. This study plans to recruit 10 patients suffering from knee cartilage lesion(s). Each recruited patient will be followed for a period of 6 months after the implantation of the Cartibeads to ensure the absence of adverse effects. The follow-up will also evaluate the success of the implantation.
(BASEC)
Intervention étudiée
If you choose to participate in this study, an intervention will be performed by your orthopedic surgeon. It involves placing the grafts onto the lesions of your cartilage. The grafts integrate spontaneously and very rapidly into the lesions within one to two weeks.
After the intervention, you will undergo rehabilitation tailored to your surgery, which will be established by your surgeon. Follow-up with a physiotherapist specializing in the musculoskeletal system will be prescribed, and appropriate measures will be suggested, such as walking with crutches, to reduce the weight supported by the knee.
As part of the study, medical checks will be performed at least 3 weeks prior to the intervention, and then at 3 months and 6 months after implantation. An MRI will be performed three times during your follow-up: at least 3 weeks before the graft, at 3 months and 6 months after the graft. You will also be asked to complete a standardized questionnaire to measure the effect of the treatment received, particularly regarding the level of pain perceived before and after surgery.
(BASEC)
Maladie en cours d'investigation
Knee chondral lesions
(BASEC)
This study is open to patients over 18 years of age, who are usually active and healthy, suffering from knee pain related to one or more cartilage lesions ranging in size from 1 to 10 cm² after debridement of the lesion. To participate, the patient must meet the inclusion criteria of the study, agree to participate, and sign an informed consent. (BASEC)
Critères d'exclusion
The study is closed to individuals suffering from chronic inflammatory joint diseases (arthritis), to individuals who are being treated or have been treated for cancer or who have significant health impairments, such as chronic diseases of the kidneys, liver, or heart, or who suffer from alcohol or drug dependence. Additionally, individuals who have undergone a procedure in the last 6 months or a therapeutic injection (hyaluronic acid, cortisone) in the last 3 months in the affected joint will not be able to participate in the study, nor will individuals who are unable to undergo magnetic resonance imaging. Individuals who have participated in another clinical study that could interfere with the study product and outcome measurements will also be excluded from the study. Pregnant women, breastfeeding women, or women not using contraception are also excluded from the study. For this reason, a pregnancy test will need to be performed before inclusion in the study. (BASEC)
Lieu de l’étude
Genève, Lugano, Zurich
(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 du Tessin
(BASEC)
Date d'approbation du comité d'éthique
05.04.2024
(BASEC)
Identifiant de l'essai ICTRP
NCT06897111 (ICTRP)
Titre officiel (approuvé par le comité d'éthique)
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 (BASEC)
Titre académique
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 (ICTRP)
Titre public
Implantation of Cartilage Mini-grafts Made from Donor Cells to Treat Chondral Lesions of the Knee (ICTRP)
Maladie en cours d'investigation
Cartilage Repair (ICTRP)
Intervention étudiée
Biological: Implantation of allogeneic cartilage mini-grafts (Allogeneic 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:
- 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 (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
701779, 2023-02168, 64935, 000005866, 701779 (ICTRP)
Résultats-Données individuelles des participants
non disponible
Informations complémentaires sur l'essai
https://clinicaltrials.gov/ct2/show/NCT06897111 (ICTRP)
Résultats de l'essai
Résumé des résultats
non disponible
Lien vers les résultats dans le registre primaire
non disponible