Cell Production Unit
The Cell Therapy Unit is a Research Support Service, which is aimed at researchers in our hospital and in other hospitals who wish to perform preclinical and clinical studies in the field of Regenerative Medicine. The unit is composed of:
- Laboratory of Therapy: environment laboratory controlled under the norms of Good Laboratory and Clinical Practices (GMP) for clinical cellular production, without expansion that does not need GMP production and for in vitro pre-clinical trials. As an example, tests have been developed, among others, for Cardiology, Gynecology, Maxillofacial, Traumatology.
- Cell Production Unit: Infrastructure that supports clinical research in Cell Therapy and Regenerative Medicine. Unit accredited by the Spanish Agency of Medicines and Sanitary Products, with authorization for the processing of 4 different cell types: mononucleated cells of bone marrow, mesenchymal cells of bone marrow, Fraction of Vascular stromal of fat (SVF) and mesenchymal cells from fatty tissue.
- The Unit of Cell Therapy is part of the “Platform of Regenerative Medicine and Bioartificial Organs” coordinated by Dr. Fernández-Avilés.
- Infrastructure for conducting pre-clinical studies in Cell Therapy and Regenerative Medicine.
- Accredited Infrastructure under the Norms of Correct Manufacturing (NCF or GMP) and PEIs (Products in Research) approved by the Spanish Agency of Medicines (AEMPs) for the production of different cell types:
- Bone marrow mononuclear cells (nº PEI: 05-042)
- Fraction of vascular stroma of fat tissue (fresh fat cells) (nº PEI: 11-020)
- Mesenchymal cells from bone marrow (nº PEI: 09-109)
- Mesenchymal cells from adipose tissue (nº PEI: 09-065)
- It should be noted that all this is done within the framework of the GLP and BPC standars, accredited by AEMPs, following therefore, a strict quality system for getting robust results that facilitate the translation to the clinic environment.