Implantation of mini cartilage grafts made from donor cells: first study in humans to treat chondral lesions of the knee
Zusammenfassung der Studie
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)
Untersuchte Intervention
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)
Untersuchte Krankheit(en)
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)
Ausschlusskriterien
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)
Studienstandort
Genf, Lugano, Zürich
(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 Tessin
(BASEC)
Datum der Bewilligung durch die Ethikkommission
05.04.2024
(BASEC)
ICTRP Studien-ID
NCT06897111 (ICTRP)
Offizieller Titel (Genehmigt von der Ethikkommission)
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)
Wissenschaftlicher Titel
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)
Öffentlicher Titel
Implantation of Cartilage Mini-grafts Made from Donor Cells to Treat Chondral Lesions of the Knee (ICTRP)
Untersuchte Krankheit(en)
Cartilage Repair (ICTRP)
Untersuchte Intervention
Biological: Implantation of allogeneic cartilage mini-grafts (Allogeneic 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:
- 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)
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
701779, 2023-02168, 64935, 000005866, 701779 (ICTRP)
Angaben zur Verfügbarkeit von individuellen Teilnehmerdaten
nicht verfügbar
Weitere Informationen zur Studie
https://clinicaltrials.gov/ct2/show/NCT06897111 (ICTRP)
Ergebnisse der Studie
Zusammenfassung der Ergebnisse
nicht verfügbar
Link zu den Ergebnissen im Primärregister
nicht verfügbar