For the first time to my knowledge, a patient has sued an American stem cell clinic, US Stem Cell, 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, 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 “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.
I followed up on the links in the comments (and thanks to all – this blog is a great stem cell resource for latecomers like myself).
So would not Dr. Burt’s therapeutic strategy be less controversial than the “dubious” stem cell clinics, as Bill calls them, because he is not administering an unapproved drug but performing a bone marrow transplant? I know that’s a bit naive, as the therapy is still not approved for MS. But does he even need regulatory / FDA approval for such a treatment?
Anyways, immune cell purging for autoimmune diseases sounds like a more rational therapeutic strategy than implanting fat stem cells with no evidence for how or how well they should work.
@Dr. Knoefler – It’s not something they advertise but here is an old link referring to it http://activemsers.wssnoc.net/showthread.php?t=437 Here is another: http://www.msworld.org/forum/showthread.php?107709-The-only-one-real-cure-for-MS/page5 Certainly it should be easy enough to email him and ask if he’s ever charged patients for the treatment and if so, how much? How about an interview? I, for one, would be interested in what he has to say. A little off topic but Dr. Kurtzberg at Duke charged CP patients for unapproved, unproven treatments before her trials got funded.
Landmark case? Isn’t that a bit premature or is it written just as an attention grabber? I have my doubts that this case will amount to much of anything.
@Jennifer – Don’t you find it interesting that Dr. Knoepfler gives Dr. Burt at Northwestern, who charges patients over $100,000 for an unapproved, unproven treatment, a pass? @Dr. Knoepfler – How is Dr. Burt’s $100,000+, unapproved, unproven treatment any different from the unapproved, unproven treatments being offered by the “dubious” stem cell clinic you seem to abhor? It’s pretty common knowledge in the MS community that Dr. Burt has been charging patients HUGE SUMS for this treatment for many years. And yet, not a peep out of you. Perhaps you can enlighten us as to criteria you use to determine whether a stem cell clinic, doctor or treatment is “dubious”. Apparently, offering unapproved, unproven treatments for huge sums of money doesn’t figure into your equation.
@Bill,
I’d like to learn more about Dr. Burt’s charging patients. Do you have links on this or other info? I’m not familiar with this practice of charging huge sums like $100K.
Thanks
Paul
Dear Jennifer Ziegler, we are needing a treatment for multiple sclerosis relapsing-remitting condition. can you recommend a clinic where we can have stem cell therapy for this disease? is the stem cell a cure or will we need to go again in the future? Thank you, Hassan Abdella
There certainly has been a lot of media attention in the past few years about stem cell clinics in the US getting shut down, and warning letters from the FDA to clinics. Seldom do we hear of a law suit being filed by a patient. I think it’s interesting considering the large number of American patients who seek cell therapy treatments in the US and abroad. Medical malpractice may be to blame in this instance, or maybe not. It will be interesting to see how this plays out. Every time I hear about a clinic or a doc getting sideways with the FDA, I scratch my head at the double standard going on here. Northwestern University is using chemo as a reboot to treat MS patients in a legitimate clinical trial, https://www.healthline.com/health-news/stem-cell-transplants-first-ms-treatment-reverses-disability-012215#1
If you don’t fit the inclusion criteria, you can pay for this therapy off trial. Assistance in obtaining funds is offered in the patient links http://www.stemcell-immunotherapy.com/patients.html
Personally I’m all for letting patients be treated off trial especially if it’s been proven safe and effective. Most patients being treated off study have exhausted all other FDA approved options. I feel there are hundreds of thousands of no option patients here in the US left hung out to dry. At least with universities offering cell therapy off study, it gives no option patients a chance of gaining quality of life improvements, if they can come up w/ $. Until something gives, I think this will be a continuing trend. I wish the patients in this law suit the best. Being a patient with no options is a horrible place to be.
@Jenny,
Thanks for your comment. I don’t see at that link information about where patients can pay to be given the therapy off trial? Can you provide more info on this? I’m trying to learn more on this.
Paul
@Hassan Abdella you’re welcome to contact me at Jenniferziegler@me.com or at patientsforstemcells.org
@Bill Jones, yes it is odd that no one in the industry, including Paul, talks about this giant double standard/elephant in the room. As a patient I hesitate to even bering this to anyones attention, because I would still like to see patients getting the treatment that they so desperately need. Dr. Burt isn’t the only one doing this. Many other FDA approved stem cell trials are treating patients off study. For now, I’m not going to say who, literally because I don’t want to bring unwanted attention to them in anyway. We’ve been talking about Dr. Burt doing this ever since the trial got started. This is NOT a news flash! Becoming a medical tourist is out of the question for so many because of the strain that travel puts on an already sick patient. As a side note, I have an MS friend that lives very near me who was treated by Dr. Burt, off study, in 2015. His friends, family and community had a really fun and creative fundraiser for him that we all got to contributed to. They raised the entire amount for his treatment. I’m quite happy to report he is doing very well!
@Admin If you click on the “patient handbook” link pg. 81, it gives the patients fundraising ideas if insurance doesn’t cover the cost. Some are even getting their insurance to pay for it! I should have stated… “Assistance in HOW to obtain funds is listed in the patient links.” Paul, I know I have brought this to your attention before, but it’s been a while. This IS happening… it’s no joke! If you say you’re just now finding our about it, I’m really surprised!
I’ve heard people say many times that some Dr.’s offer and charge patients for off trial treatments using the same product in the trial, but if I could see actual concrete evidence of this I would be very interested in learning more.
@Admin…I think this sounds like a perfect opportunity for you to call and ask and then do an blog post about your results. I think your readers would be interested to understand more too. Here is all the information you would need to do that. Let us know what you find out.
Division of Immunotherapy
Northwestern Memorial
Faculty Foundation
676 N St. Clair, 14th floor
Chicago, IL 60611
312-908-0059
312-908-0064 (Fax)
http://www.nmff.org
I have emailed Dr. Burt asking about this and will let you know what I hear.
The allegations include failure to adequately inform the patient, but presumably the patient signed a consent form, More importantly, misrepresentation is alleged (i.e. the drug was not fit for purpose), but to elucidate this necessitates scientific and medical argumentation, and as MSCs are widely reported to inhibit inflammation and vascularization, and promote regenerative processes, this line of argument will be unproductive.
Interestingly, I read many statements that could have been taken from this blog and others, such as no scientific evidence, non-approved applications. This may be true, but is insufficient to support prosecution.
Which leaves the, “serious permanent damage” sustained by the patient. We are not given details, but if mistakes in the surgical procedure were made, then the surgeon can be made the scapegoat, leaving the application of MSCs for this disease unaffected and this is more damaging in the long run.
The key question is whether the patient was informed of any potential adverse effects, and these will be laid out in the consent form (in the small print). Depending on the degree of damage and the resulting bad press, the best the patient can hope for is an out of court settlement and from the way the allegations are laid out, I believe this is what the plaintiff is aiming for.
A stem cell injection is the infusion of healthy stem cells to replace cells that are damaged. Necessary chemotherapy and radiation therapy could be effective for the treatment.
Bioheart changed its name to US Stem Cell Inc – I believe it was some time in 2015.