Regulatory Issues for Personalized Pluripotent Cells

Authors

  • Maureen L. Condic,

    1. Department of Neurobiology and Anatomy, University of Utah School of Medicine, Salt Lake City, Utah, USA
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  • Mahendra Rao

    Corresponding author
    1. Regenerative Medicine, Invitrogen Corp., Carlsbad, California, USA
    2. Neurosciences, Johns Hopkins School of Medicine, Baltimore, Maryland, USA
    • Maureen L. Condic, Ph.D., University of Utah School of Medicine, Department of Neurobiology and Anatomy, 401 MREB, 20 North 1900 East, Salt Lake City, Utah 84132-3401, USA. Telephone: 801-585-3482; Fax: 801-581-4233
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Abstract

The development of personalized pluripotent stem cells for research and for possible therapies holds out great hope for patients. However, such cells will face significant technical and regulatory challenges before they can be used as therapeutic reagents. Here we consider two possible sources of personalized pluripotent stem cells: embryonic stem cells derived from nuclear transfer (NT-ESCs) and induced pluripotent stem cells (iPSCs) derived from direct reprogramming of adult somatic cells. Both sources of personalized pluripotent stem cells face unique regulatory hurdles that are in some ways significantly higher than those facing stem cells derived from embryos produced by fertilization (ESCs). However, the outstanding long-term potential of iPSCs and their relative freedom from the ethical concerns raised by both ESCs and NT-ESCs makes direct reprogramming an exceptionally promising approach to advancing research and providing therapies in the field of regenerative medicine.

Disclosure of potential conflicts of interest is found at the end of this article.

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