NEJM paper links 3 blinded patients to publicly-traded stem cell clinic

Do 3 blinded stem cell clinic patients with major or complete vision loss constitute a significant adverse outcome?

I would say so and a new paper details how this happened apparently at a particular publically-traded South Florida stem cell clinic business.

You can see the damaged retinas of one such patient below in an image from a new NEJM paper reporting the severe adverse outcomes. The red areas are hemorrhaging with other substantial damage to the retina as well.

How did this all happen?

stem cells eyes

Kuriyan, et al. 2017 NEJM Figure 2A

Last year the story began to break of multiple patients alleging they had been blinded by different businesses in South Florida. Dr. Thomas Albini presented on some information on this at the FDA meeting last fall, but things weren’t entirely clear. Back then there were also indications of lawsuits by patients related to alleged vision loss due to experimental stem cell offerings against various parties involved.

Now we have more details on some of the cases in this new NEJM article (Kuriyan, et al.) in which the authors attribute these patients’ experiences to a withdrawn “trial”, NCT02024269, which lists Bioheart (now known as US Stem Cell, Inc.) as the sponsor. I put “trial” in quotes because it was withdrawn and also because as best as I can tell this wasn’t a traditional FDA-approved trial of the kind normally based on pre-clinical data and an IND. US Stem Cell, Inc. is a publicly-traded company ($USRM) and its stock has been all over the place this year. I’m not aware of US Stem Cell having FDA approval for what it is doing.

The NEJM article oddly does not mention Bioheart or US Stem Cell, Inc. by name as the place where the patients were given the stem cells, but the authors do clearly link them together and other information further supports this connection. Continue reading

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.

Update on patients lawsuit against stem cell clinic, Stemgenex

StemGenexThe website Law360 has an interesting update on the proposed class action lawsuit against the San Diego stem cell clinic Stemgenex.  Note that it seems you can read the full Law360 article without a subscription if you open the site in Chrome as your web browser. See more background on Stemgenex and on this case here.

Not surprisingly, the plaintiffs and defense see this case in opposite ways as reflected in quotes in the Law360 article:

“Plaintiffs make non-specific and conclusory allegations with respect to all named defendants,” StemGenex said. “The second amended complaint is so devoid of any specific facts to support its contentions that it is impossible for defendants to reasonably prepare a defense.”

Brian Findley of Mulligan Banham & Findley, a lawyer for the plaintiffs, told Law360 Wednesday that the allegations are “quite specific” and cite false statistics, made-up online reviews and StemGenex employees. If customers told the company that the treatment hadn’t done anything, they were told it could take months to see an effect, or that they should buy another treatment, he said.”

A key issue in this case is the marketing of stem cell offerings from Stemgenex and the plaintiffs allege this marketing was problematic:

“The three StemGenex customers, Selena Moorer, Stephen Ginsberg and Alexandra Gardner, all say that they paid the company $14,900 for each stem cell treatments for lupus, diabetes and other ailments after being persuaded by the number of satisfied customers on the company’s website, but that the treatments had no effect.”

The Stemgenex website still lists an apparent 100% patient satisfaction marketing claim as of today, January 23, 2017 (see screenshot below).

stemgenex

Screenshot from Stemgenex website

According to the Law360 article, Stemgenex has made various arguments to support their motion for dismissal and they overall called the lawsuit a “fishing expedition.”

If you want to follow the case, here is some info:

“The case is Moorer v. StemGenex Medical Group Inc., et al., case number 3:16-cv-02816, in the U.S. District Court for the Southern District of California.”

It seems likely that more patient suits against stem cell clinics will emerge this year. Some, but not all of the other recent cases of this kind including against US Stem Cell, Inc. and its subsidiary US Stem Cell Clinic have been settled before any judgment was issued. I’m not sure of the status of a different proposed potential class action case against The Lung Institute. If you know of other such lawsuits please contact me or post a comment.

Dang: ad for stem cell clinic @Sciam article on our paper on stem cell clinics

What a strange Internet world we live in these days, huh?

Leigh Turner and I just published a piece in Cell Stem Cell on the state of the US stem cell clinic market finding 570 clinics and this paper has drawn a lot of media attention including a piece in Scientific American (Sciam).

Stem cell clinic advertisement

Screenshot from Scientific American article on paper on stem cell clinics that has a stem cell clinic ad at right. Note that that ad is not part of the article, but is an actual ad.

I’m glancing over that Sciam article just now and BOOM I see an ad for a stem cell clinic appear at the top and it is even one of the ones in the database we created for our article. The ad is focused on selling stem cells to treat autism in children, an area that raises a lot of questions.

How can it be a good thing to have an ad for a stem cell clinic right next to the article about the challenge of stem cell clinics in America? The way the web works these days, perhaps it isn’t so surprising that articles having anything to do with stem cells will often be accompanied by ads for stem cell clinics. This one just really stuck out to me today because of the context.

US Stem Cell Clinic sues anonymous critics for libel, seeks IDs from websites

U.S. Stem Cell, Inc.Last month the stem cell community learned that a patient of the business US Stem Cell Inc./US Stem Cell Clinic, previously known as Bioheart, had filed suit in a Broward County Florida Court against the publicly traded company alleging various charges including damage to her eye.

Now US Stem Cell has more recently filed suit in the same court against one or more anonymous online critics for libel/slander. In this new case, US Stem Cell Inc versus John Doe, et al, the company points to specific instances on stock investing message boards where anonymous commenters discussed the company, and alleges that certain comments constitute libel/slander.US Stem Cell Libel Suit

If you are interested in reading the details of this new or the earlier case, you’ll have to search for it on the Broward County Court website using this tool given idiosyncrasies of that website that make it so that one cannot directly link to cases or documents. This is in fact how I found out about the new case when I searched for Bioheart there to see if there was anything new on the patient suit and saw the new suit.

In the newer case, the alleged anti-Bioheart/US Stem Cell comments were made on Yahoo Message Boards and iHub Message Boards. From reviewing the most recent court filings in the case, it would appear that US Stem Cell so far has not been able to identify these commenters so it asked the court to allow subpoenas of Yahoo and iHub to provide the identities of the person or persons who are defendants in the case.

This US Stem Cell situation reminds one of the ongoing case involving PubPeer, where a professor has sued to identify anonymous commenters who he believes caused him injury. Of course there are some major differences, but also a few parallels.

Free speech, public discourse, and transparency are essential to biomedical science including both for academia and in the for-profit stem cell world. I allow anonymous commenters on this blog, but sometimes moderating comments that some individuals make that are extreme such as personal attacks or statements about companies that just go too far is a challenge. There are times I have no choice but to edit or delete them because they violate our comment policy, but I don’t like to do that if it can be avoided so it is a rare event. Also, certain anonymous comments can be some of the best in terms of providing new information or stimulating vigorous discussions. The toughest situation is when comments fall into a gray zone of potentially being useful in terms of providing information or a new perspective, but at the same time including material that is questionable.

These are difficult dilemmas.