The Interdisciplinary Stem Cell Institute’s Use of Food and Drug Administration-Expanded Access Guidelines to Provide Experimental Cell Therapy to Patients With Rare Serious Diseases

The Interdisciplinary Stem Cell Institute’s Use of Food and Drug Administration-Expanded Access Guidelines to Provide Experimental Cell Therapy to Patients With Rare Serious Diseases

The U.S. Food and Drug Administration (FDA) provides guidance for expanded access to experimental therapies, which in turn plays an important role in the Twenty-first Century Cures Act mandate to advance cell-based therapy. In cases of incurable diseases where there is a lack of alternative treatmen...

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Bibliographic Details
Main Authors: Aisha Khan, Michael A. Bellio, Ivonne H. Schulman, Allan D. Levi, Bangon Longsomboon, Adriana Brooks, Krystalenia Valasaki, Darcy L. DiFede, Marietsy V. Pujol, Dileep R. Yavagal, Karen E. Bates, Ming-Sing Si, Sunjay Kaushal, Barth A. Green, Kimberly D. Anderson, James D. Guest, Stephen Shelby Burks, Risset Silvera, Andrea J. Santamaria, Anil Lalwani, W. Dalton Dietrich, Joshua M. Hare
Format: Article
Language:English
Published: Frontiers Media S.A. 2021-06-01
Series:Frontiers in Cell and Developmental Biology
Subjects:
mesenchymal stem cells
clinical investigation
expanded access IND
schwann cell
single patient IND
Online Access:https://www.frontiersin.org/articles/10.3389/fcell.2021.675738/full

Internet

https://www.frontiersin.org/articles/10.3389/fcell.2021.675738/full

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