At the Antwerp University Hospital, these dendritic cells have been tested in clinical trials in patients with acute myeloid leukemia, breast cancer, brain cancer and mesothelioma. There are already signs that with the dendritic cell administration, the cancer can be brought under control in part of the patients. In addition, the general survival of the patients seems to be increased, even when the disease is not cured.
The direct costs for the preparation of one series of dendritic cells, starting from one white blood cell collection procedure in one patient, used to be 19.000 € but has climbed at present to 25.000 €. These costs, which do not have to be payed by the patients and which are not covered by health insurance, have been supported by grants from the hospital and from government and cancer associations. The costs have increased because the European and Belgian legislations now consider dendritic cells as 'advanced therapy medicinal products (ATMP)', which have to be produced like pharmaceutic drugs, under certified 'good manufactoring practice (GMP)' norms.
Because of this, the clean rooms and the dendritic cell preparation procedures have to conform to very stringent criteria and have to receive an authorization from the Federal Agency for Medicines and Health Products (FAMHP; Federaal Agentschap voor Geneesmiddelen en Gezondheidsproducten (FAGG)), following audits and inspections. In December 2014, the Center for Cell Therapy and Regenerative Medicine of the Antwerp University Hospital became the first hospital and academic center in Belgium to have been granted a production authorization and a GMP certificate for dendritic cells.
Prof. Dr. Z. Berneman
Professor of Hematology, University of Antwerp
Head, Division of Hematology & Medical Director
Center for Cell Therapy and Regenerative Medicine
Antwerp University Hospital (UZA)