Knee osteoarthritis: when surgery isn’t your only option

¿es la cirugía la única opción ante una artrosis de rodilla?

Is surgery the only option for advanced knee osteoarthritis? We review what gonarthrosis is, what the clinical evidence shows on cultured mesenchymal cells (CMC), and what requirements ITRT applies when evaluating alternatives authorized by the AEMPS.

The role of AEMPS in advanced cell therapy drugs

sede AEMPS Madrid agencia española medicamentos de terapia celular avanzada

The AEMPS supervises the full lifecycle of advanced cell therapy medicinal products with cultured mesenchymal cells (CMC): clinical trials, GMP manufacturing, clinical application, and pharmacovigilance.

Cellular dose in cultured mesenchymal cells (CMC): why it is the parameter that changes everything

How the cellular dose is defined for applying advanced therapy medicinal products with cultured mesenchymal cells (CMC)

Before undergoing any procedure involving mesenchymal cells, there is one question that should be answerable with documentation: how many cells will be administered, and how has that number been verified? If no concrete answer exists, the procedure is not classified as a regulated medicinal product. The cellular dose is the technical and regulatory criterion that marks that difference. In this article, we explain how it is defined, how it is certified, and why it is decisive in indications such as tendons, cartilage, and lumbar disc disease, from the clinical and scientific perspective of ITRT.