Richard Jaffe, Esq.

In my last post on stem cells, I painted a pretty bleak picture. Based on warning letters and recent FDA guidance documents, the clinical use of autologous stem cell therapeutics is essentially over. The only way patients are going to be able to receive autologous stem cell transplants for non-homologous use is either in FDA approved clinical trials or outside the United States. This hasn’t gone unnoticed in Congress. In March, 2016, a bill was introduced, by Senator Mark Kirk…

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In 2003, I did my first stem cell case, and it was, as far as I know, the first time the Feds investigated a physician for the clinical use of stem cells. Mitch Ghen had treated a couple of dozen ALS patients with umbilical cord blood. He obtained the material from a Florida cord blood bank. The Feds found out and were not happy. So a half dozen agents raided his clinic in 2003.  After the raid, they threatened to…

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