Open Access2005 Donor Eligibility Requirements: Unintended Consequences for Stem Cell Development
Author(s) -
Couture Larry A.,
Carpenter Melissa K.
Publication year - 2015
Publication title -
stem cells translational medicine
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.781
H-Index - 71
eISSN - 2157-6580
pISSN - 2157-6564
DOI - 10.5966/sctm.2015-0045
Subject(s) - flexibility (engineering) , embryonic stem cell , food and drug administration , risk analysis (engineering) , transplantation , preclinical testing , stem cell , regenerative medicine , business , microbiology and biotechnology , computer science , medicine , biology , medical physics , surgery , biochemistry , gene , statistics , mathematics
Several human embryonic stem cell (hESC)‐derived cell therapeutics have entered clinical testing or are in various stages of preclinical development. Ambiguity in the guidelines and the redundant testing requirements have unintentionally created a burdensome regulatory paradigm. A simple solution is proposed to address FDA safety concerns, eliminate regulatory uncertainty and risk, and provide flexibility for the FDA in the regulation of hESC‐derived cell therapies.