2nd lawsuit alleging a U.S. stem cell clinic caused blindness

Concerns over stem cell clinics allegedly causing blindness or other vision problems have been increasing in 2016. If this is in fact happening, the extra sad part of this is that some clinics have claimed that they are doing the opposite: improving vision in patients.U.S. Stem Cell, Inc.

What are the concerns?

Earlier this year a publicly-traded stem cell business in Florida called U.S. Stem Cell, Inc. was sued along with other defendants by a former customer Elizabeth Noble, alleging harm done via an experimental stem cell “treatment” for vision. That case appears settled.

SEC filings by U.S. Stem Cell also disclosed another suit against them involving a different plaintiff, Patsy Bade. Note that U.S. Stem Cell Inc. used to be called Bioheart, Inc., has a subsidiary called U.S. Stem Cell Clinic LLC, and that Kristin Comella is a leader of U.S. Stem Cell.

From the SEC Filing by U.S. Stem Cell:

“On September 17, 2015, a product liability lawsuit was filed in Broward County, specifically Patsy Bade v. Bioheart, Inc. US Stem Cell Clinics LLC, Aleiandro Perez, ARNP, and Shareen Greenbaum, M.D., and on November 30, 2015, a product liability lawsuit was filed in Broward County, specifically Elizabeth Noble v. Bioheart, Inc. US Stem Cell Clinics LLC, Aleiandro Perez, ARNP, and Shareen Greenbaum, M.D. During the six months ended June 30, 2016, both matters settled by the Company’s insurance policy with no additional cost to the Company.”

I’ve been wondering about the circumstances of Bade’s suit, which like the Noble case was mentioned as being in Broward County, but the Bade case didn’t appear on their county court website. As a result, I did other research as time permitted.hollywood-eye-institute

court search in the adjacent Miami-Dade County using the search term “Bioheart”, again the old name of U.S. Stem Cell, Inc., revealed that Bade had filed a lawsuit in that county against some of the same parties involved in the Noble case.

Bade has apparently settled with US Stem Cell, Inc., but as best as I could tell as a non-attorney she has not so far settled with Dr. Shareen Greenbaum and her place of business the Hollywood Eye Institute.

What did Bade claim had happened?

She alleged that a stem cell treatment she received caused her to go blind, an allegation that remains unconfirmed to my knowledge. This case raises pressing questions though. I recommend reading the amended complaint document if you want to at least try to learn more. It is publicly available on the court site and I have posted it here. U.S. Stem Cell, Inc. and its leader Kristin Comella are mentioned extensively in the amended complaint.

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Rick Perry’s Paid Board Position at Controversial Stem Cell Clinic Celltex

Rick Perry stem cellsIf you rewind the stem cell clock several years, the big news in the stem cell clinic arena was dominated for quite some time by a single stem cell clinic called Celltex in Texas in part because their most famous customer was Governor (at that time) Rick Perry. You can read the many past posts I’ve done on Celltex here.

Today the stem cell clinics are making news more for their sheer numbers (nearly 600 in the U.S. alone), but a few years back Celltex and Perry were stirring things up and getting noticed in large part because they were tangling with the FDA. Celltex and their former partner RNL Bio were cooking up a stem cell product that did not have FDA approval and the agency issued Celltex a warning letter. Perry was a supporter of Celltex.

Now Perry is more than just a supporter or patient of Celltex, he reportedly has a paid position on the stem cell clinic’s board. No longer governor nor running for president, perhaps Perry wants to devote more time to stem cells?

The Celltex of today remains a Texas business, but is selling stem cell treatments only (to my knowledge) administered across the border in Mexico. The change in clinical location was it seems an attempt to get outside the range of authority of the FDA. What will Perry’s actual operational role be? I don’t know. The AP got this quote:

“I’m a big believer in adult stem cells,” Perry told The Associated Press by phone Thursday. “My reputation is important to me and I want to be associated with companies I believe in.”

I actually met and talked with Governor Perry a few years back when Celltex was more on the radar screen and he was still governor. The meeting was down at Scripps in a meeting set up by Jeanne Loring. Several other physicians and scientists were present. He struck me as very excited about stem cells and eager to get businesses to move to Texas.

ABC News has this quote from Celltex on this development:

“Celltex CEO David Eller said in an emailed statement. “Given this passion, it is natural he joined the board of a premier U.S.-based biotechnology company that is known for its unparalleled adult stem cell technology now that he has left public service.”

I’m curious what the future holds for Celltex and every now and then I hear rumors of them potentially doing some treatments in the US or getting an IND from the FDA or something like that.  I did note that at least one of their patients spoke at the recent FDA stem cell meeting.

Anyone heard other news on Celltex?

Report on day 2 of FDA stem cell meeting: patients, researchers, & more

The FDA’s stem cell meeting wrapped up today on day two with a diverse group of individual speakers. A series of patient testimonials today in favor of clinics was one thing that stood out. You can read my take of day one and the account of Jeanne Loring who was at the meeting. I’ve noted that on average about 350 people were watching the webcast of the meeting both days.

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Screen shot from FDA stem cell meeting webcast

The patients gave powerful, often emotional testimonials today on their experiences at various stem cell clinics including Celltex and most prominently Stemgenex. I think there were 7 of its patients who spoke. I have no doubt of the patients’ sincerity in their belief that they’ve been helped.

Various stem cell clinic doctors also testified.

As with yesterday, a common statement was that there are “no side effects” of stem cell treatments, which is concerning as all medical therapies have some risk of side effects.

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Guide to September 12-13 FDA Stem Cell Meeting: Top 10 bullet points

The FDA is holding a 2-day stem cell meeting starting tomorrow and it promises to be a really big deal. What’s the scoop on this meeting and the attendees?

Who is likely to say what?

Stem cell cartoon

If the deregulatory proponents get their way, could we have stem cell clinics like Starbucks popping up in even more neighborhoods? I have a satirical cartoon from some time ago I drew imagining such a future.

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Negative stem cell clinic outcomes in the U.S. include 3 blinded women

What can go wrong with unapproved stem cell clinics? The answer including from presentations at the FDA today turns out to be very serious, negative results right here in the U.S.

Thomas Albini, MD gave a talk entitled,  “Severe Visual Loss After Intravitreal Injection of Autologous Adipose Tissue-derived Stem Cells for Age-related Macular Degeneration”.

Stem cell clinic transplants of fat stem cells led to blindness in three women, reported Dr. Albini.

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We’ve heard encouraging news about how stem cells might help patients regain lost vision or preserve existing vision in the face of a disease like macular degeneration in the future. There’s real potential there with rigorous clinical trials that are ongoing.

Here in this very different case we heard from Dr. Albini about how stem cells inappropriately used by a stem cell clinic in South Florida reportedly caused 3 women to go blind. All had retinal detachment potentially, Dr. Albini said, due to the fat stem cells taking up residence and resulting in pulling of the eye tissue internally. A nurse practitioner reportedly did the transplants rather than a physician. The patients assumed, we were told in the talk, that the listing in clinicaltrials.gov of the “trial” meant the interventions were legit.

This is such a deeply tragic case we can only hope that more people aren’t blinded from this kind of stem cell clinic offering. More on this situation here at Nature by Heidi Ledford.

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Michael Miller, MD, PhD, spoke next with his talk entitled, “Glioproliferative Lesion of the Spinal cord Arising from Exogenous Stem Cells.” This case already has had quite a lot of media attention and involves stroke patient Jim Gass, who ended up with a large spinal tumor that dramatically negatively affected his health. We have to give Mr. Gass huge credit for having the courage to go public with this case. He got ES cells and allo MSCs both in China. Then he traveled to Argentina for autologous MSCs and then to Mexico where he got MSCs and neural stem cells. See image above from the talk. The spinal tumor had many weird features of various primitive tumors. It was clearly a malignancy. There were no major cancer-related mutations detected in the OncoPanel assay.

The bottom line. So when those promoting stem cell clinics or wanting much less oversight ask “what can go wrong?” and they don’t really believe much can go wrong, we now know for sure that that view is just not accurate. Intensely bad stem cell clinic outcomes are occurring right here in the U.S.