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Translating stem cell research from the bench to the clinic: A need for better quality data

Published

Author(s)

Anne L. Plant, graham C. parker

Abstract

A new generation of cell therapies shows great medical promise, but few new products have made it into the marketplace. The technical challenges associated with the application of stem and other cells for therapies are paralleled by the challenges associated with investment funding and regulatory approval. Regulators and investors appear to be voicing similar concerns: they see 1) an insufficient amount of high quality data that provide confidence regarding the claims of medical benefit, 2) an insufficient understanding of the mechanism of action, and 3) a lack of identification of essential characteristics for product release criteria and for assuring reproducibility in manufacturing. The ensuing frustration on the part of researchers and developers may be the result of failure to fully comprehend what is required to assure that confidence.
Citation
Stem Cells and Development
Volume
22
Issue
18

Keywords

stem cells, cell therapy, measurement assurance, cell biology, regulatory approval, biomanufacturing

Citation

Plant, A. and parker, G. (2013), Translating stem cell research from the bench to the clinic: A need for better quality data, Stem Cells and Development, [online], https://doi.org/10.1089/scd.2013.0188 (Accessed July 14, 2024)

Issues

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Created August 29, 2013, Updated November 10, 2018