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Private clinics marketing unproven stem cell treatments spur FDA to act

AJN The American Journal of Nursing: November 2017 - Volume 117 - Issue 11 - p 15
doi: 10.1097/01.NAJ.0000526735.29023.2f
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Private clinics marketing unproven stem cell treatments spur FDA to act. The Food and Drug Administration (FDA) is cracking down on what it calls “unscrupulous clinics” offering unproven and potentially dangerous stem cell treatments for a variety of illnesses, including heart failure. A survey published in JAMA Internal Medicine found that among 39 such clinics targeting patients with heart failure, the mean cost of a single treatment was $7,694 for autologous (using a person's own cells) and $6,038 for allogenic (using donor cells) cells. Only one of 79 physicians working at these clinics was board certified in cardiology, and 10 were described as naturopathic practitioners. The health risk to consumers is considerable as the cells are administered intravenously, and FDA agents found that several clinics had substandard laboratory and manufacturing processes. Moreover, noted FDA commissioner Scott Gottlieb in an August statement, the exploitation of vulnerable patients by such “unscrupulous actors” puts the nascent field of stem cell therapy research at risk.

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