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Stem Cell DialoguesA Philosophical and Scientific Inquiry Into Medical Frontiers$
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Sheldon Krimsky

Print publication date: 2015

Print ISBN-13: 9780231167482

Published to Columbia Scholarship Online: November 2015

DOI: 10.7312/columbia/9780231167482.001.0001

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PRINTED FROM COLUMBIA SCHOLARSHIP ONLINE (www.columbia.universitypressscholarship.com). (c) Copyright University of Minnesota Press, 2021. All Rights Reserved. An individual user may print out a PDF of a single chapter of a monograph in CUPSO for personal use.date: 24 July 2021

How My Cells Became Drugs

How My Cells Became Drugs

Chapter:
(p.173) Dialogue 24 How My Cells Became Drugs
Source:
Stem Cell Dialogues
Author(s):

Sheldon Krimsky

Publisher:
Columbia University Press
DOI:10.7312/columbia/9780231167482.003.0024

This dialogue is a fictional account of the legal arguments before the U.S. District Court, District of Columbia, regarding the case United States v. Regenerative Sciences LLC. A company named Regenerative Sciences established a clinic in Broomfield, Colorado, to treat patients with a range of orthopedic conditions, including fractures that failed to heal and chronic bursitis, with a stem cell therapy it called RegenexxTM. The therapy consisted of mesenchymal stem cells taken from the patient's bone marrow and grown in tissue culture for about two weeks. The Food and Drug Administration (FDA) warned Regenerative Sciences that its use of stem cell treatments constituted unlicensed biologics and violated federal law. Regenerative Sciences argued that their procedure represented medical practice and lay outside of FDA's jurisdiction. The FDA brought suit against Regenerative Sciences in the United States District Court for the District of Columbia.

Keywords:   biologics, United States v. Regenerative Sciences LLC, stem cell therapy, mesenchymal stem cells, bone marrow, Food and Drug Administration

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