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FDA's Cellular, Tissue and Gene Therapies Advisory Committee meets on HESC-derived therapies

Next Thursday, April 10, 2008, FDA's Cellular, Tissue and Gene Therapies Advisory Committee will meet to discuss scientific considerations for safety testing for cellular therapy products derived from human embryonic stem cells. (1)
A Briefing Document is provided, "Cellular Therapies Derived from Human Embryonic Stem Cells--Considerations for Pre-Clinical Safety Testing and Patient Monitoring" .(2)
The meeting notice indicates that no specific products will be discussed for regulatory review purposes. Instead invited experts and manufacturers who are developing cellular therapies derived from HESCs will present information on some of the issues concerning development of these types of products.
The goal of the meeting is to obtain expert advice regarding product characterization, preclinical testing and design of clinical studies sufficient to ensure patient safety in the first clinical trials of HESC-derived cell therapy products.
FDA has considerable experience in the evaluation of investigational cell therapy products and has published several relevant guidance documents to facilitate safe progress in this field. (3)
However, they note that the use of cellular products derived from HESC's present unique challenges worthy of further consideration.
Given the clinical considerations described in the briefing document, many of which are factors that are common to trials of cell therapy products in general, FDA indicates that phase 1 trials of HESC-derived cellular products will have to be capable of measuring some indications of efficacy, or at least desirable therapeutic activity. Considerations of both safety and potential benefit will affect the selection of cell dose as well as other characteristics of early -phase clinical trials--a reasonable balance between risk and benefit will be likely only in patients with the targeted disease.


(1) http://www.fda.gov/OHRMS/DOCKETS/98fr/E7-24629.htm
(2) http://www.fda.gov/ohrms/dockets/ac/08/briefing/2008-0471B1_1.pdf
(3) FDA/CBER/OCTGT. (2008) Cellular and Gene Therapy publications http://www.fda.gov/cber/gene.htm, Guidance for Reviewers: insturctions and Template for Chemistry, Manufacturing, and Control (CMC) Reviewers of Human Somatic Cell Therapy Investigational New Drug Applications (INDS) http://fda.gov/cber/gdlns/cmcsomcell.htm

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