[Cell therapy: from experimentation to innovative medical practice].
Like all new and emerging technologies, cell therapy has raised many hopes for the treatment of some severe diseases. However, its development needs first a clear ethical and legal framework. Because of the complexity and cost of these therapies, development has to be focused on fields where clinical benefits appear greater and where therapeutic alternatives are limited. Since 28 May, 1996 France has had a law (No. 96-452) which defines the 'biological products for therapeutic use' and therefore cell therapy. Many different therapeutic domains are concerned, depending on cell type. The level of development already reached and the number of patients concerned are quite variable. The grafting of hematopoietic stem cells and of expanded keratinocytes, which concerns in France 2500 and 100 patients per year respectively, are well characterized. The clinical trial of dendritic cells for vaccination is just starting but could represent a very large field of application with more than 10,000 patients per year. The grafting of hepatocytes, and the production of antiviral CTL and encapsulated cells (Langerhans islets of allo- or xenogenic origin), nerve cells, and myocytes are still at an early stage of development. Whatever the field, before entering clinical trials, a clear scientific and medical rationale must exist. The efficacy and security of the proposed treatment should be established on relevant models. Cell processing protocols must be well characterized and reproducibility proven with quality controls in place and the cell processing facilities approved by the relevant authorities. Partnership with industry could take many different forms. It should speed up development by providing access to reagents, growth factor of clinical grade, devices, cell processing technologies, etc., without preventing investigators from conducting their trial as planned.
Hervé
P
P
Etablissement de Transfusion Sanguine de Franche-Comté, Besançon, France.
Lepecq
J B
JB
D000818:Animals; D064987:Cell- and Tissue-Based Therapy / Q000379:methods* / Q000639:trends; D002986:Clinical Trials as Topic; D003713:Dendritic Cells / Q000637:transplantation; D005602:France; D018380:Hematopoietic Stem Cell Transplantation; D015603:Keratinocytes / Q000637:transplantation; D007883:Legislation, Medical; D008099:Liver / Q000166:cytology