Journal
STEM CELLS TRANSLATIONAL MEDICINE
Volume 1, Issue 1, Pages 36-43Publisher
WILEY
DOI: 10.5966/sctm.2011-0001
Keywords
Cellular therapy; Neural differentiation; Pluripotent stem cells; Reprogramming
Categories
Funding
- GMP laboratory (EEBSCRC)
- NIH [1RC1AR058333, P01-GM081621]
- Department of Defense [85280103]
- Foundation to Eradicate Duchenne
- UCLA Muscular Dystrophy Core Center [5P30AR057230]
- UCLA P30
- CIRM: New Cell Lines awards [RL1-00681-1, RL1-00636]
- CIRM Young Investigator Award [RN1-00564]
- EEBSCRC
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The clinical application of human-induced pluripotent stem cells (hiPSCs) requires not only the production of Good Manufacturing Practice-grade (GMP-grade) hiPSCs but also the derivation of specified cell types for transplantation under GMP conditions. Previous reports have suggested that hiPSCs can be produced in the absence of animal-derived reagents (xenobiotics) to ease the transition to production under GMP standards. However, to facilitate the use of hiPSCs in cell-based therapeutics, their progeny should be produced not only in the absence of xenobiotics but also under GMP conditions requiring extensive standardization of protocols, documentation, and reproducibility of methods and product. Here, we present a successful framework to produce GMP-grade derivatives of hiPSCs that are free of xenobiotic exposure from the collection of patient fibroblasts, through reprogramming, maintenance of hiPSCs, identification of reprogramming vector integration sites (nrLAM-PCR), and finally specification and terminal differentiation of clinically relevant cells. Furthermore, we developed a primary set of Standard Operating Procedures for the GMP-grade derivation and differentiation of these cells as a resource to facilitate widespread adoption of these practices. STEM CELLS TRANSLATIONAL MEDICINE 2012;1:36-43
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