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

Clin Pharmacol Ther. 2007 Oct;82(4):448-52. doi: 10.1038/sj.clpt.6100321. Epub 2007 Aug 8.

Abstract

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.

Publication types

  • Research Support, Non-U.S. Gov't
  • Review

MeSH terms

  • Cell Culture Techniques* / standards
  • Cell Differentiation
  • Cell Proliferation
  • Cell Separation* / standards
  • Embryo Research* / legislation & jurisprudence
  • Embryonic Stem Cells / physiology
  • Embryonic Stem Cells / transplantation*
  • Government Regulation
  • Human Experimentation* / legislation & jurisprudence
  • Human Experimentation* / standards
  • Humans
  • Quality Control
  • Regenerative Medicine / legislation & jurisprudence
  • Regenerative Medicine / methods*
  • Regenerative Medicine / standards
  • Stem Cell Transplantation* / legislation & jurisprudence
  • Stem Cell Transplantation* / standards
  • United Kingdom