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Derivation of GMP Raw Materials for Use in Regenerative Medicine: hESC‐based Therapies, Progress Toward Clinical Application
Author(s) -
Hewitt Z A,
Amps K J,
Moore H D
Publication year - 2007
Publication title -
clinical pharmacology and therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.941
H-Index - 188
eISSN - 1532-6535
pISSN - 0009-9236
DOI - 10.1038/sj.clpt.6100321
Subject(s) - clinical trial , clinical pharmacology , regenerative medicine , embryonic stem cell , medicine , intensive care medicine , pharmacology , food and drug administration , microbiology and biotechnology , stem cell , biology , biochemistry , gene , genetics
The potential of somatic cell therapies from human embryonic stem cells (hESCs) as alternatives to traditional drug‐based remedies for treating some of mankind's most debilitating diseases has resulted in the need to translate rapidly proof‐of‐principle and basic research into clinical application. Consequently, researchers and regulatory bodies are now facing one of the major obstacles of the field: the efficient and reproducible generation of clinical‐grade cells suitable for producing therapeutic cell types to administer to patients in phase‐I and phase‐II clinical trials. Clinical Pharmacology & Therapeutics (2007) 82 , 448–452. doi: 10.1038/sj.clpt.6100321 ; published online 8 August 2007