New trial: Umbilical-derived stem cells for knee cartilage
This small German biotech company is joining the knee OA stem cell race.
BIONCaRT GmbH has received approval from the EMA (Europe’s FDA) to evaluate the safety & efficacy of its umbilical-derived stem cell therapy for knee cartilage repair, MesemCart.
It’s a single-arm Phase I/IIa trial where 55 patients will receive 10-20 million MSCs to the cartilage defect, they’ll be evaluated for outcomes over 2 years. The product will also be applied to a collagen carrier structure called Chondro-Gide, made by Geistlich.
Chondro-Gide is a bilayer collagen I/III membrane developed specifically for cartilage regeneration. It’s made of highly refined porcine collagen, produced in Switzerland. Geistlich says it provides a 3D supportive matrix for adhesion and cell differentiation, and cells can be seeded on the rough side of the bilayer membrane, while the smooth side prevents cell loss during the process.
Here’s a video on that:
The primary outcome measured will be serious adverse events within 24 months; secondary outcomes will include the regeneration of cartilage using the MOCART score at 12 months.
Here’s the link to the trial page:
https://clinicaltrials.gov/study/NCT06981741?intr=mesenchymal&rank=4
