Derivation of GMP raw materials for use in regenerative medicine: hESC-based therapies, progress toward clinical application.

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.