January 18, 2021

The Niche

Trusted stem cell blog & resources

stem cell clinics

3 min read

It’s not every day that I call a bunch of stem cell clinics to say “hi”, but yesterday I called some of them during a needed lunch break from grant writing to see what they were doing about their operations during the COVID-19 pandemic. The impetus for this survey of a sort was a question someone asked me last week, “Are stem cell clinics still open during the pandemic? They can’t be, right?” That got me thinking — could these clinics selling injections of …Read More

4 min read

It can be kind of a big deal when politicians, especially at the federal level, write the FDA about stem cells. Is this going to be good news or bad? Some combination? I tend to worry that some senators or representatives might pressure the FDA to weaken oversight. However, lately it seems like the opposite is happening. Perhaps pressure the other direction, for less oversight, doesn’t see the light of day. Last April Senator Grassley wrote the FDA about problematic stem cell clinics and …Read More

3 min read

Maybe the announcement that Commissioner Scott Gottlieb will be leaving the FDA soon shouldn’t have caught us all off-guard, but it did. Gottlieb isn’t a perfect Commissioner, but he brought a sensible, open approach to running the FDA that was very refreshing. Amongst all the top leadership in the Trump administration, Scott Gottlieb stood out as being particularly supportive of his agency and its core mission. If anything he was the anti-politician in the room. Is that what did him in? It’d be helpful …Read More

4 min read

The US has been bursting at the seams with unproven stem cell clinics for years, which in my view necessitates some kind of bold action by the FDA and other governmental agencies so I’ve wondered what new FDA Commissioner Dr. Scott Gottlieb would do on this front. The lead up to and beginning of a likely crackdown A subset of these clinics are particularly risky and egregious in their behavior. While this subset constitutes may be “only” one or two hundred such clinics out …Read More

3 min read

Scrolling through a stem cell clinic website can be a surreal experience. Going from the top of the page to the bottom can leave one feeling turned upside down. I wonder what the FTC thinks when they see these sites? Usually at the top of the webpage for many unproven stem cell clinics are big claims, glossy pictures of healthy people, and a lot of buzz. However, often if you then scroll down to the bottom there is some very different fine print with …Read More

3 min read

When you think of an ecosystem, do you imagine something like a forest or jungle full of different organisms? I usually do, but over the last few years I’ve also been thinking about this concept in a different way. I’ve been viewing the broad stem cell arena as an ecosystem. In that spirit, I’ve recently published a new paper in Regenerative Medicine that delves into the idea of a “stem cell ecosystem”. This system has many parts and if you view it historically it …Read More

3 min read

I’m enjoying attending and speaking at the annual Science Writers 2018 meeting in D.C. where I spoke this morning on a panel about stem cells. The session was specifically on the Wild West of stem cells. You can follow the meeting events on Twitter with the #sciwri18 hashtag. I had three wonderful fellow panelists, Marilynn Marchione of the AP, Terry Devitt of the University of Wisconsin, and Dr. Peter Marks, Head of CBER at the FDA (pictured). Marilynn and Terry ran the session. The session was …Read More

3 min read

Attorney Richard Jaffe, who has been an advocate for clinics to have the right to sell and patient to buy unproven therapies such as the stem cells sold by clinics and unproven cancer therapies, just did a kind of shocking u-turn on a specific point. Jaffe and I have very different philosophical views of the unproven stem cell clinic arena with him favoring less and me favoring much more FDA oversight. He may be most well known overall for having been the attorney for …Read More

2 min read

I’m becoming increasing convinced that patient suits against stem cell clinics are going to have strong impact, including based on the new steps taken by a particular law firm. For background, I’ve written extensively about these suits over the years and we’ve seen more recently that another academic group (Claire Horner, Evelyn Tenenbaum, Douglas Sipp, Zubin Master) has published a paper on the suits. The law firm stepping up against clinics is GRYC or Grossman, Roth, Yaffa, and Cohen. They not only have and continue to represent …Read More

3 min read

One of the most common claims made by unproven, for-profit stem cell clinics is that the stem cells they are selling can help knee arthritis and associated pain, but what is the evidence to back this up? There are many problems with the claims of stem cells for arthritis being made across the U.S. In quite a few cases what is being sold isn’t even real stem cells. It often is an amniotic extract, which probably isn’t from actual stem cells anyway and is …Read More