Cell Therapies Regulated

A further committee. The Committee for Advance Therapies, is to be established under regulation (EC) No. 1394/2007 to deal with issues raised by emerging drug products based on gene therapy, somatic cell therapy and tissue engineering. 

Kessler, D., Siegel, J., Noguchi, P, Zoon, K., Feidon, K. and Woodcock, J. (1993). Regulation of somatic-cell therapy and gene therapy by the food and Drug Administration. New Engl. J. Med. 329 1169-1173. 

No further extensions to the period referred to in the first subparagraph shall be permissible except in the case of trials involving the medicinal products listed in paragraph 6, for which an extension of a maximum of 30 days shall be permitted. For these products, this 90-day period may be extended by a further 90 days in the event of consultation of a group or a committee in accordance with the regulations and procedures of the Member States concerned. In the case of xenogenic cell therapy there shall be no time limit to the authorisation period. 

The proteasome is a ubiquituous enzyme complex that plays a critical role in the degradation of many proteins involved in cell-cycle regulation, apoptosis, and angiogenesis. Since these pathways are fundamental for cell survival and proliferation, particularly in cancer cells, the inhibition of proteasome is an attractive potential anticancer therapy. The ubiquitin/proteasome pathway is the main nonlysosomal route for degradation and is responsible for the... 

Schletter J. Regulatory requirements for stem cell-based therapies. Regul Affairs J 2003 14. 

Stinchcomb, D. (1995) Constraining the cell cycle Regulating cell division and differentiation by gene therapy. Nature Med. 1, 1004-1006. 

Molecular Therapy. 2000-. Elsevier Academic Press. Monthly. ISSN 1525-0016. URL http //www.elsevier.com/ locate/issn/1525-0016. Covers gene transfer, gene regulation, gene discovery, cell therapy, experimental models, correction of genetic and acquired diseases, and clinical trials. Official journal of the American Society of Gene Therapy (ASGT). 

T. Neff, C.A. Blau, Pharmacologically regulated cell therapy, Blood 2001, 97, 2535-2540. 

NIS expression in thyroid tumors correlates with their ability to concentrate radioiodine. Schmutzler et al. (1997) reported that downregulated expression of the NIS gene resulted in resistance to 1-131 therapy because it reduced iodide uptake in thyroid cancer cells. The regulation of NIS expression in normal and malignant thyroid cells has been extensively investigated, and various agents have been recognized to influence expression. 

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