The Regional University Hospital of Malaga has a Cell Manufacturing Unit to manufacture advanced therapy medicinal products in accordance with GMP guidelines. This Unit covers an area of approximately 88m2 which is divided into 3 rooms for manufacturing cell therapy and tissue engineered medicinal products.
Since October 2012, the laboratory has been authorized by the Spanish Agency of Medicines and Medical devices (AEMPS) for the isolation and expansion of autologous adipose tissue-derived mesenchymal stem cells.
The qualified personnel working in this unit are manufacturing medicinal products in research for the purposes of two clinical trials:
- Multicentre, phase I/II, double blind, randomized and comparative of two patient groups to evaluate the safety and efficacy of autologous mesenchymal stem cells derived from fat tissue in the treatment of faecal incontinence.
- Multicentre, phase I/II, randomized, placebo controlled, triple blinded, to evaluate safety, feasibility and evaluation of intravenous therapy with 3 doses of autologous mesenchymal stem cells from adipose tissue in patients with moderate to sever Amyotrophic lateral sclerosis.