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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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.

Wait, there’s an FDA stem cell meeting this week too? The scoop

stem cell crystal ball

Stem cell Crystal Ball

There’s a big FDA stem cell meeting coming along next week that has gotten much attention, but many people didn’t realize there’s also an FDA meeting on stem cells this week too in three days on September 8th.

I pasted this week’s meeting schedule at the bottom of this post from the FDA page. The meeting is a workshop entitled, “Public Workshop: Scientific Evidence in the Development of Human Cells, Tissues, and Cellular and Tissue-Based Products Subject to Premarket Approval”.

The meeting next week on September 12-13 getting all the attention is entitled, “Draft Agenda: Part 15 Hearing: Draft Guidances Relating to the Regulation of Human Cells, Tissues, or Cellular or Tissue-Based Products”.

Within the “Human Cells, Tissues, and Cellular and Tissue-Based Products” or HCT/P larger category the ones getting the most attention are stem cells. If you look at the speakers at this week’s meeting including the keynote by Irv Weissman, it’s pretty clear this meeting is focused squarely on stem cells even though it could apply to other products.

What’s the difference between the meetings?

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