Cell Laboratories

sala blanca Xcelia

Xcelia Photo: Cleanroom for cell production

The practical medical team and the cell production team work together to form a coordinated research group. The stem cell selection and culture procedures are conducted in specialised laboratories duly accredited by the Spanish Agency of Medicines and Medical Devices (AEMPS), led by investigators with a wealth of experience in this field. The cell product released to the medical team to be administered is categorised as an "advanced therapy investigational medicinal product" and must be handled as such. For this reason, cell production is governed by extremely stringent pharmaceutical standards known as GMP-Good Manufacturing Practices.

ITRT holds a scientific collaboration agreement for the production of cell-based medicinal products with the following highly-accredited laboratories:
 
Xcelia is the advanced therapies unit of the Blood and Tissue Bank of Barcelona (BST). The first bone regeneration studies using the Aastrom Replicell System bioreactor developed by the North American company Aastrom Biosciences were conducted in 2002 at this centre, which is accountable to the Department of Health of the Regional Government of Catalonia and directed by Dr Joan García López. Xcelia, in collaboration with ITRT, is currently conducting research into  osteoarthritis treatment and producing cells for personalised treatments administered subject to approval from, and under the supervision of the AEMPS.
 
The Institute for Biology and Molecular Genetics (IBGM) is a centre managed by the University of Valladolid and the Spanish National Research Council (CSIC). Its Cell Production Unit, directed by Prof. Ana Sánchez García, has held accreditation for the production of cells for human use since 2007. In the same year, ITRT signed an agreement with this centre for the conduct of a clinical trial on disc regeneration. It is currently conducting research into osteoarthritis treatment and producing cells for personalised treatments administered subject to approval from, and under the supervision of the AEMPS.
 
Histocell is a biopharmaceutical company located at the Vizcaya Science Park and affiliated with the Department of Biology and Histology of the Faculty of Medicine of the University of the Basque Country (Universidad del País Vasco). Sponsored by the pharmaceutical company SALVAT and directed by Dr Begoña Castro, it has designed a procedure that allows adipose tissue-derived mesenchymal stem cells to be incorporated into a biomaterial, which can be used to treat bone damage such as pseudarthrosis. The clinical trial assessing its efficacy is being conducted by ITRT and Hospital Universitario La Paz of Madrid.
 

 

LAGENBIO is a biochemical genetics laboratory located at Hospital Clínico Veterinario of the University of Zaragoza. Under the leadership of Prof. Clementina Rodellar, it produces cells for ITRT for use in ovine or equine animal research models.