IBIMA has three GMP (Good Manufacturing Practices) rooms in Pavilion A of the Regional University Hospital (RUH) of Malaga where clinical trials are carried out with cell therapy medicinal products. These are facilities that meet specific parameters for manufacturing based on stem cells for therapeutic purposes and which are subject to strict safety requirements verified by the Spanish Agency for Medicines and Health Products (AEMPS), the entity responsible for providing final accreditation for operation. Manufacturing operations authorized by AEMPS, to date, are isolation and expansion of mesenchymal stem cells derived from adipose tissue.
After inspection and authorization by the AEMPS, these rooms house new clinical trials in cell therapy for diseases that do not have or do not respond adequately to conventional treatments such as Amyotrophic Lateral Sclerosis (ALS), or structural Fecal incontinence; all funded projects and currently underway at the RUH.
The facilities cover an area of 92 m2 on the seventh floor of Pavilion A of HRU Malaga. Both the infrastructure and the team that supports the CPU, foster different lines of R&D in Cell Therapy and cater to the different medical-surgical disciplines of the Andalusian Public Health Service (SSPA) hospitals and other partner institutions wishing to implement Cell Therapy and Regenerative Medicine as treatment. These facilities are isolated and expand “ex vivo” cells to be used in humans, either in the clinical research phase or as treatment. These clean rooms are integrated into a network of 12 Cell Production units within Andalusia in eight centers in the provinces of Cordoba, Granada, Malaga and Seville. They are structured within the framework of the Andalusian Initiative in Advanced Therapies (IATA) sponsored by the Department of Health, in collaboration with the Department of Innovation, Science and Enterprise, which aims to promote the development and application in clinical practice of results of research in the field of cell therapy, gene therapy and nanomedicine.