The Business & Regulation of Stem Cells

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Economics of Regenerative Medicine

The article explores the economics of regenerative medicine, a field of medicine that deals with the regeneration of tissues and organs. The author discusses the challenges faced by the regenerative medicine market, including the high cost of treatments, lack of insurance coverage, and lack of regulation. The author also predicts that the market for regenerative medicine is expected to grow significantly in the coming years, driven by increasing demand and decreasing cost.

Mesenchymal stem cells (MSCs) and the FDA

The article provides information about the regulation of mesenchymal stem cells (MSCs) by the U.S. Food and Drug Administration (FDA). The FDA has issued guidance documents for the development and manufacturing of MSC-based products and established a regulatory pathway for the Investigational New Drug (IND) application process. The article highlights that currently, no MSC-based products have been approved for use in humans, but the FDA continues to evaluate new data and monitor the use of MSCs.