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Previous Volume 355:1730-1735 October 19, 2006 Number 16 Next

	Since this article has no abstract, we have provided an extract of the first 100 words of the full text and any section headings.

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In the interest of public safety, the Food and Drug Administration (FDA) has jurisdiction over the production and marketing of any stem-cell–based therapy involving the transplantation of human cells into patients. The FDA's recently promulgated regulations regarding human cells, tissues, and cellular and tissue-based products¹ provide an appropriate regulatory structure for the wide range of stem-cell–based products that may be developed to replace or repair damaged tissue.

Basic and clinical scientists, as well as scientists working in the biotechnology and pharmaceutical industries, need an increased awareness of the questions that must be answered before a stem-cell–based product can be used . . . [Full Text of this Article]

The Regulatory Framework for Stem-Cell–Based Products

Demonstration of Preclinical Safety and Efficacy

Does the Donor Pose a Risk of Transmitting Infectious or Genetic Diseases?

Does Cell or Tissue Processing Pose a Risk of Contamination or Damage?

What Types of Cells Are in the Product and What Are the Purity and Potency?

Will the Product Be Safe and Effective in Vivo?

Stem-Cell–Based Products and Gene Therapy

Conclusions

Source Information

From the School of Medicine, University of California at San Francisco, San Francisco.

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