Skip to main content
U.S. flag

An official website of the United States government

Official websites use .gov
A .gov website belongs to an official government organization in the United States.

Secure .gov websites use HTTPS
A lock ( ) or https:// means you’ve safely connected to the .gov website. Share sensitive information only on official, secure websites.

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 November 21, 2024)

Issues

If you have any questions about this publication or are having problems accessing it, please contact reflib@nist.gov.

Created August 29, 2013, Updated November 10, 2018