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Cell therapy clean room

Presentation

In the last two decades, the tremendous progress in the knowledge and development of advanced research methods and technologies in cellular and molecular biology have allowed the creation of a new discipline: the so-called regenerative medicine . Its purpose is to achieve the repair and functional recovery of damaged or injured tissues.

This discipline is currently subdivided into three main areas:

  • Cell Therapy.
  • Gene Therapy.
  • Tissue Engineering.

Its bases

From the point of view of cell therapy, the scientific basis for its development is undoubtedly the knowledge of the pluripotentiality of some cells present in different organs and tissues. Pluripotentiality is understood to mean the ability of a cell to replicate giving rise to copies of itself and to differentiate, in appropriate environments, into various cell types, eventually being able to create new tissues. Fundamental mechanism in the natural processes of tissue self-repair, the use of this knowledge and the growing capacity to induce and modulate differentiation processes towards different cell types in the laboratory, currently allows us to achieve significant functional improvements and recoveries in some diseases. At this time there is intense research to expand the list of health problems that can be addressed through cell therapy.

To guarantee the safety of patients undergoing this therapy, the European Commission has issued a series of regulations that classify any implantation of cells that have been cultured, expanded and manipulated as cellular medicine. Spanish regulations transpose European regulations. This means that all regulations relating to medicines and pharmaceutical products (on manufacturing, dispensing, quality controls, safety, etc.) also apply to these treatments. & Nbsp; Therefore, accredited facilities and procedures are needed for the manufacture of cellular drugs. In our country, legislation requires that the Spanish Agency of Medicines and Health Products ( AEMPS ) authorize the administration of these cellular products in clinical trials to based on the accreditation of a cellular medicine as a Investigational Product ( PEI) . In turn, to obtain an accredited IEP, an extensive preclinical and animal research program is necessary to provide the necessary guarantees for the initiation of human trials.

The room was created with the objective of applying advanced cellular therapies that have proven their safety and efficacy to patients in our Community. Therefore, it aims to treat patients from other health centers in Osakidetza / Basque Health Service. It also aims to support manufacturing processes from PEI generated by research teams from other centers.

Pathologies and research

The pathologies in which preclinical research is being carried out in the Hospital, in order to obtain the PEI accreditation of the AEMPS :

  • Critical arterial ischemia of the lower extremities.
  • Corneal limbic insufficiency.
  • Injuries to the articular cartilage of the knee.
  • Osteogenesis imperfecta.
  • Hirschsprung's disease.

Platform members

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