FDA Stem Cell Update

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Practitioners offering unproven and unapproved STEM CELL treatments for hair growth should be on notice: the FDA has started to bump up its regulation.  Companies such as R3 Stem Cell LLC have already received warning letters from the FDA and others have already had their day in court and have preliminary judgements against them.1,3  Since there is NO APPROVED or PROVEN stem cell treatments for hair growth (although legitimate studies2 are ongoing at reputable hair clinics), it is a welcome change for caring hair practitioners who have watched as patient hopes are dashed and resources squandered in the desire for more hair.  Florida and Arizona companies have been targeted in the last few weeks, and more companies in other states are under scrutiny.

CNN reported3 that many of these clinics falsely promote stem cell therapies for numerous diseases or conditions, in effect preying on vulnerable patient populations.  These treatments are not only a sham, they are potentially hazardous.  According to he New England Journal of Medicine, three women who opted for stem cell treatment for their macular degeneration were left blind after a Stem Cell treatment in 2015.4

The FDA has not approved any stem cell-based products for use as treatments other than blood-forming stem cells derived from umbilical cord blood, according to the agency’s website.5

Acting FDA Commissioner Dr. Ned Sharpless said, “The reality is that at this time, there isn’t enough evidence to support the use of stem cells for purposes other than reconstitution of blood formation and the immune system.” Have you been promised hair growth from stem cells without effect?  Adverse events related to Stem Cell products should be reported to the FDA’s MedWatch Adverse Event Reporting program.6

 

 

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