title: Translating stem cell research from the bench to the clinic: a need for better quality data.
abstract: Stem cell therapies show great medical promise, but few new products have made it into the marketplace. The translation of stem and other cell therapies faces not only challenges associated with research and development, but also the challenges of investment funding and regulatory approval. Regulators and investors alike appear to be voicing the same concerns: they see (1) insufficient high-quality data to 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.
authors.affiliation: Materials Measurement Laboratory, Biosystems and Biomaterials Division, National Institute of Standards and Technology, Gaithersburg, Maryland 20899, USA. anne.plant@nist.gov
authors.forename: Anne L
authors.initials: AL
authors.lastname: Plant
authors.forename: Graham C
authors.initials: GC
authors.lastname: Parker
mesh_terms: D064987:Cell- and Tissue-Based Therapy / Q000379:methods*; D006801:Humans; D057905:Stem Cell Research; D033581:Stem Cell Transplantation / Q000379:methods*; D013234:Stem Cells