What’s the deal with US Stem Cell Inc stock?

The stem cell clinic business US Stem Cell Inc., formerly known as Bioheart, has seen its stock take a rollercoaster ride recently include a big run up and now today a big drop so what’s the scoop?

US Stem Cell, which includes a few subsidiaries such as US Stem Cell Clinic, focuses on the use of adipose stem cells to treat a variety of health conditions in people, as well as training and pet treatments.

US Stem Cell Inc Stock USRM

To my knowledge, the company does not have FDA approval such as an IND for the stem cell interventions that it sells. In addition, there is some debate over whether adipose stem cells/stromal vascular fraction is a biological drug. As a stem cell scientist and close follower of the field, I believe it is a drug. Note that I’m not aware of the FDA having taken any action on US Stem Cell or its competitors who use adipose stem cells. The company has also recently settled two patient lawsuits, which included allegations of harm to vision by a number of entities.

On the potential upside for investors, it seems there remains strong demand across the US and the world amongst patients for what stem cells clinics are offering even without FDA approval.

Why is the US Stem Cell Inc stock moving so much recently?

It looks like an investment research firm put out a report on the company and the report apparently details the company making deals outside the U.S. and in the Middle East so this may be part of what is driving the stock to move around.

There also seems to be something recent about a lawsuit settlement on social media, but seems pretty vague so hard to say if it is accurate or means something.

Any other thoughts?

Disclosure: I have no investment in stem cell/regenerative medicine stocks including US Stem Cell or its competitors.

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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US stem cell clinic sued for injection into patient’s eyes: landmark case?

U.S. Stem Cell, Inc.For the first time to my knowledge, a patient has sued an American stem cell clinic alleging damage to her eyes from fat stem cell injections. Just a few months ago, there was a report of a Japanese patient who sued a fat stem cell clinic and won, but I’m not aware of a similar case in the US until now.

Elizabeth Noble, who reportedly received a stem cell injection into her eyes for macular degeneration by U.S. Stem Cell, Inc., has filed suit against the company (note that the court website makes it hard to link to specific detailed pages so I recommend going to this general page where you can enter search terms if you are interested in the documents). This is  CACE15021101. You can read the full complaint of the plaintiff in the suit here as a PDF.

Two specific individuals are named as defendants in the case: nurse practitioner Alejandro Perez, ARNP, and Dr. Shareen Greenbaum, M.D.

Dr. Greenbaum was mentioned and quoted in a PR about a stem cell trial with Bioheart from about two years ago related to macular degeneration. She is currently working at the Hollywood Eye Institute in Florida. Mr. Perez is listed on the U.S. Stem Cell, Inc. “about us” webpage as being part of the team.

Importantly, neither U.S. Stem Cell, Inc. (USSC) and U.S. Stem Cell Clinic (USCC; owned by USSC) nor the individuals mentioned in the lawsuit have been found guilty of anything and this case is still pending so it is impossible to know for certain what did or did not happen. On the USCC website it indicates that this clinic uses both fat and bone marrow stem cells depending on the condition.

I could only find one possible clinical trial, which has been cancelled, which lists Bioheart and macular degeneration on a quick search of clinicaltrials.gov. There could be others.