August 6, 2020

The Niche

Knoepfler lab stem cell blog

New stem cell clinic insights from trio of critical media pieces

Screenshot from US Stem Cell Clinic YouTube video on how they prepare the fat stem cell product
Screenshot from US Stem Cell Clinic YouTube video on how they prepare the fat stem cell product, which is a common stem cell clinic offering

Three recent media pieces on unproven, for-profit stem cell clinics paint an unflattering picture of this industry.

At the intersection of these pieces is the clinic “treatment” consisting of fat stem cells (being manufactured as in a screenshot at right from a clinic YouTube video), a product the FDA has indicated is most often going to be a biological drug requiring pre-market approval, which the clinics generally do not have.

The newest newspaper article comes from The Washington Post. Laura McGinley and William Wan take a close look at stem cell clinics including especially one in Georgia, the large group it belongs to called Cell Surgical Network, the recent Grassley letter, and US Stem Cell, Inc. (and its sub-business US Stem Cell Clinic). The title of the WaPo piece gives a reader the immediate sense this is not the kind of media coverage that unproven stem cell clinic firms probably want: “Miracle cures or modern quackery? Stem cell clinics multiply, with heartbreaking results for some patients.”

Michael Hiltzik of The LA Times also has a new piece on stem cell clinics, more squarely focused on US Stem Cell and its leader, Kristin Comella. It is entitled, “Patient lawsuits, federal investigations and a ‘virtual’ PhD: Inside a would-be stem cell empire”.

As to the reference to the doctoral degree, Hiltzik writes:

“The field also strives to adopt a veneer of scientific legitimacy. Consider Comella’s stem cell biology doctorate. It was issued by the Panama College of Cell Science, which identifies itself as a nonaccredited “virtual university.” The Republic of Panama-based college offers a three-year online PhD at a price of $2,950 a year — $2,700 if paid in advance. The college calls its program “the hottest, most powerful biology graduate program in the world.”

I’ve written before over the years about US Stem Cell on this blog so there is quite a bit of background at that link. However, Hiltzik’s piece provides some additional new perspectives and info such as on the degree above and the reported ongoing plans for the business to spread across the country via a specific investment firm:

“The expansion of the company’s clinic network is being done through an outside investment firm, General American Capital Partners, which hired Comella, U.S. Stem Cell’s chief scientific officer, and Michael Tomas, its chief executive, to act in the same capacity in the rollout of American Stem Cell Centers of Excellence, the brand name of the proposed clinics. U.S. Stem Cell says the investors have committed to spend $2.5 million to open the 10 clinics.”

That’s a sizable investment, especially for a marketed healthcare service that is neither FDA approved nor scientifically proven via appropriately rigorous double-blind controlled studies.

Finally, Ron Hurtibise at Florida’s Sun Sentinel also has a new piece on unproven clinics including US Stem Cell. It focuses on a few fronts including in particular on the Grassley letter last week to HHS/FDA. The federal agencies were requested to reply to Grassley by last Friday.

As far as I can see on the web at least there hasn’t been a reply, but according to the Sun Sentinel, “FDA spokeswoman Tara Rabin said by email Thursday that the agency plans to respond to Grassley’s letter.” Maybe there was a reply but it is confidential or the reply is coming soon.

The Sun Sentinel also asked his office about why Grassley got interested in this stem cell situation, which had been a topic of discussion in the comments on my blog post on the Senator’s letter:

“Asked why the senator took an interest in the issue, the aide responded, “Sen. Grassley has a long record of conducting vigorous oversight. In this case, he wants to make sure the FDA is properly overseeing matters within its jurisdiction and holding alleged wrongdoing to account.”

Grassley doesn’t seem like someone who’s magnifying glass you want to be under. Many are curious about what the FDA will say in reply and most importantly what if anything the agency will do on the stem cell clinic front.

Hang onto your hats as the next couple months could see some big developments.

%d bloggers like this: