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.
Hewitt
Z A
ZA
Sheffield Stem Cell Derivation Facility, Centre for Stem Cell Biology, University of Sheffield, Sheffield, UK. z.hewitt@sheffield.ac.uk
Amps
K J
KJ
Moore
H D
HD
D018929:Cell Culture Techniques / Q000592:standards; D002454:Cell Differentiation; D049109:Cell Proliferation; D002469:Cell Separation / Q000592:standards; D033041:Embryo Research / Q000331:legislation & jurisprudence; D053595:Embryonic Stem Cells / Q000502:physiology / Q000637:transplantation*; D033161:Government Regulation; D006805:Human Experimentation / Q000331:legislation & jurisprudence / Q000592:standards; D006801:Humans; D011786:Quality Control; D044968:Regenerative Medicine / Q000331:legislation & jurisprudence / Q000379:methods* / Q000592:standards; D033581:Stem Cell Transplantation / Q000331:legislation & jurisprudence / Q000592:standards; D006113:United Kingdom