Swissmedic, has approved the phase 1 clinical trial (“First in man”, 10 patients involved) for the treatment of articular cartilage lesions of the knee with autologous cartilage microtissues named Cartibeads™.
Cartibeads is a tissue-engineered pharmaceutical product which falls into the category of ATMP (Advaced therapy medicinal product). It was developed and patented by Vanarix SA, a Swiss company based in Lausanne, Switzerland.
In summary, the study involves the harvesting a small cartilage biopsy from a non load-bearing area of the patient’s knee. The chondrocytes isolated from that sample are cultured and engineered to produce microtissues (Cartibeads™) to be re-implanted into the same patient’s knee after 5 to 6 weeks.
The Lugano Cell Factory, startin from April 2020, has optimized and validated the manufacturing process and the analytical methods.
LCF supported Vanarix SA in obtaining the Swissmedic authorization and it is now the only manufacturing site authorized to produce Cartibeads according to GMP standard.
In summary, the study involves the harvesting a small cartilage biopsy from a non load-bearing area of the patient’s knee. The chondrocytes isolated from that sample are cultured and engineered to produce microtissues (Cartibeads™) to be re-implanted into the same patient’s knee after 5 to 6 weeks.
The Lugano Cell Factory, startin from April 2020, has optimized and validated the manufacturing process and the analytical methods.
LCF supported Vanarix SA in obtaining the Swissmedic authorization and it is now the only manufacturing site authorized to produce Cartibeads according to GMP standard.
