Universidad de Navarra – Clínica Universidad de Navarra
The Cellular Therapy Area (CTA) co-ordinates a multidisciplinary team of basic and clinical research in the CUN and CIMA around the therapeutic use of advanced therapy medicinal products (MTAs). CTA in collaboration with other centres is currently conducting several independent clinical trials with MTAs. These immunotherapy trials are conducted in the GMP (Good Manufacturing Practices) laboratory of the CTA. The laboratory operates under strict quality system that ensures compliance with GMP. GMP Laboratory has been authorised by the Government of Navarra for the production of idiotype autovaccines under good manufacturing practice in accordance with Royal Decree 288/1991 and in accordance with the provisions of Directive 89/342/EEC. The GMP laboratory has also certification that they work under GMP conditions by the Spanish Agency for Medicines and Health Products (AEMPS) according to the principles and guidelines of good manufacturing practice laid down in Directive 2003/94/EC for a total of 10 different MTA: skeletal myoblasts, autologous dendritic cells, mesenchymal cells derived from adipose tissue, mesenchymal cells derived from bone marrow, autologous CD133 cells, autologous endothelial progenitors derived from bone marrow, autologous epidermal sheets, limbocorneal cells, tumour infiltrating lymphocytes (TIL) and lymphokine activated killer (LAK). In the past 5 years the CTA group has participated as a producer laboratory in more than 20 clinical trials. In all these projects, the CTA group has been responsible for the validation of equipment and procedures and of the preparation of the therapeutic products under good manufacturing practice. In addition the group has actively participated in the design and development of the protocol of the clinical trial.