Wednesday, January 31, 2018

The Unregulated Stem Cell Wildfire: Fresh Look at Practices Not Approved by the FDA

They have crept across the country like a malignant rash, popping up from coast to coast. They take tens of thousands of dollars from desperate people from seeking a cure for afflictions ranging from cancer to blindness. Instead some become more ill.

You can see it yourself on your computer screen in the comfort of your own home. Just click on the map above. It was brought to you by Paul Knoepfler of UC Davis and Leigh Turner of the University of Minnesota. Back in 2016, they published the first ever look that documented the size of the unregulated stem cell clinic market. And California led the way with the most clinics.

Recently, they probed more deeply. Knoepfler wrote last week on his blog,
"In our new paper, Leigh and I also found that clinics marketing certain conditions and types of stem cells exhibited specific trends over the years. For instance amniotic stem cell clinics, while lagging behind bone marrow and fat stem cell clinics in numbers, show a sharp upward trend. This spike fits with increasing mainstream media advertising efforts by amniotic clinics.
The Regenerative Medicine article is ensconced behind a pay wall, but here is a snippet from its summary.
"Between 2009 and 2014, the number of new US stem cell businesses with websites grew rapidly, at least doubling on average every year. From 2014 to 2016, approximately 90–100 new stem cell business websites appeared per year. In contrast, from 2012 to the present, regulatory activity in the form of FDA warning letters has been limited. These data point to a problematic disconnect between a rapidly expanding US direct-to-consumer stem cell industry and limited FDA oversight of this marketplace. More consistent, timely and effective FDA actions are urgently needed."
Knoepfler said on his blog,
"While Leigh and I documented the nearly 600 clinics as of 2016, my sense is that there are likely to be upwards of 700 clinics today. What will the map of stem cell clinics look like in 2019 or 2020? What do you think? Fewer? More? Or about the same number of clinics? What would similar temporal maps of clinics in other countries look like?"
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