A new stem cell clinic lawsuit has popped up and this one, like some others, relates to a patient alleging vision loss due to a non-FDA approved stem cell offering and involves U.S. Stem Cell, Inc. (formerly called Bioheart).
American stem cell clinics market direct-to-consumer stem cell offerings for a whole medical dictionary’s worth of health conditions including vision loss. However, while stem cells have real promise for being the basis of future, safe and effective treatments for various forms of vision loss based on clinical trials run through the FDA and other similar international regulatory bodies, there is little if any concrete evidence that fat or bone marrow stem cells can be safely and effectively used for macular degeneration or other forms of vision loss right now.
In my opinion, offering stem cells outside the IND-based traditional FDA-related clinical trial process for vision loss is extremely risky, particularly when both eyes are injected at once, and has little if any chance of efficacy. Also, keep in mind that finalized FDA guidances now indicate that fat stem cells generally are a biological drug requiring pre-market approval.
In this new case, a patient named Jeannine Mallard with dry AMD is suing U.S. Stem Cell, Inc., affiliated businesses U.S. Stem Cell Clinic and Regenestem, as well as Kristin Comella, who is a leader of these firms, alleging vision loss due to an experimental treatment in which reportedly non-FDA approved fat stem cells were injected into both of Mallard’s eyes. You can read the case filing here.
Kuriyan, et al. 2017 NEJM Figure 2A “The patient had bilateral vitreous hemorrhages and diffuse intraretinal and preretinal hemorrhages.”
There are quite a number of allegations in this suit, but at the core is the claim that U.S. Stem Cell, et al. injured Mallard’s eyes “causing permanent blindness”. Past lawsuits, now settled, against U.S. Stem also made similar allegations of the clinic having caused blindness with stem cell injections. Dr. Thomas Albini reported at a 2016 FDA meeting and in some publications on cases of eye damage related to stem cell clinic experiments. You can see an example from one of their papers of retinal damage in the image above and they cited a few specific trials that they associated with vision loss including the one now withdrawn by Bioheart.
U.S. Stem Cell, which says it no longer markets stem cells for vision loss, has responded to this new suit. The text of this lawsuit and the U.S. Stem Cell PR not surprisingly seem at odds over certain facts of the case. For instance, there is a key difference in the purported roles of U.S. Stem Cell and Comella in the procedure on the patient.
From the Plaintiff’s filing:
“Defendant Kristin C. Comella, an aerobics instructor at the YMCA in Weston, Florida, serves as U.S. Stem Cell’s chief scientific officer at the Clinic. Ms. Comella is not a physician, and, at all times relevant to the lawsuit, she did not have any degree in medicine or cell biology. Nonetheless, Ms. Comella touted herself as an expert in adipose stem cell research and actively participated in Defendant’s stem cell procedures at the Clinic.”
“…Dr. Greenbaum, assisted by Defendant Comella performed the ‘stem cell’ treatment…”
(Note: here it seems they are referring to Dr. Shareen Greenbaum, who from past documents it seems worked with U.S. Stem Cell, et al.)
And a very different take from U.S. Stem Cell:
“U.S. Stem Cell and its affiliated entities did not administer the treatment to the patient. The procedure was performed by an outside practitioner, who is among the hundreds of trained doctors worldwide who utilize U.S. Stem Cell, Inc. technology. U.S. Stem Cell does not currently treat eye patients, and for nearly 20 years, clinics have safely conducted thousands of stem cell procedures utilizing our protocol. We remain committed to the development of effective cell technologies to treat patients with a variety of diseases and injuries.”
So what actually happened?
If the case proceeds hopefully the field can get a clearer sense of the facts of this situation, but it is possible that if the case is settled we may not learn much.
Still, there are a number of interesting statements and tidbits in both the Plaintiff’s court filing and U.S. Stem Cell’s response. I recommend reading them. For instance, as to cost, the filing indicates Mallard paid U.S. Stem Cell Clinic $9,000 ($7K for treatment and $2K for storage.) Note that an amended complaint document from the settled case involving patient Patsy Bade also provides some background relevant to this situation.
U.S. Stem Cell suggests in their PR in response to the new lawsuit that it has had a broad role in this arena:
“To management’s knowledge, USRM has completed more clinical treatments than any other stem cell company in the world in the past 20 years, and has certified more than 700 physicians and veterinarians in autologous stem cell therapy worldwide.”
I’d be curious how many of those 700+ practitioners are now selling experimental stem cell offerings to human patients. What exactly does “certified” mean here? Who has or should have the authority to “certify” someone else to transplant experimental stem cells into human patients for profit? There are many questions in this area.
An additional question is whether FDA and other governmental authorities (e.g. state or federal agencies) will do anything further related to for-profit stem cell clinics across the U.S. directly marketing non-FDA approved stem cells to patients as more cases of alleged and in some cases documented patient harms accumulate. The FDA recently issued a warning letter to U.S. Stem Cell Clinic, but the status of the issues raised in the letter as well as the state of the discussion between the firm and the FDA at present remain unclear.
Another situation I’ll broadly refer to as “The SCOTS Trial” in Florida has also sparked allegations of patient vision loss as well, via administration of bone marrow stem cells in this case into the eyes of customers. I’m not aware of the FDA addressing the SCOTS situation in some way at this point and those running SCOTS have argued that they have helped a number of patients. What’s happened and what’s going on now? The stem cell arena needs to learn more facts about this situation too.
So what’s the bigger picture take home message at this point?
Overall, we’ll have to wait and see how the FDA guidances play out in real world situations and what actions if any the FDA takes about past activities by for-profit clinics across our country. What if anything will the FDA do during the 3-year period it has given for stem cell businesses to adjust to the guidances? FDA has the discretion to take actions sooner in cases it views as particularly risky, but will it do more, for instance, in 2018?
In my view as a stem cell researcher and someone who has followed the arena for a long time, it feels like substantial additional FDA action and clarity regarding for-profit stem cell clinics in America is urgently needed sooner rather than later.