The Mayo Clinic claims stem cell therapy “offer great promise for new medical treatments.” Contrast that with the what the FDA says, “Stem cells have been called everything from cure-alls to miracle treatments. But don’t believe the hype. Some unscrupulous providers offer stem cell products that are both unapproved and unproven. So beware of potentially dangerous procedures—and confirm what’s really being offered before you consider any treatment.”
Which one is right? The answer is, “both.” Regenerative medicine using stem cells holds great promise for the future. But many of the early pioneers are quacks. In fact, they are dangerous quacks.
In this post we look at U.S. Stem Cell Clinic LLC which was just on the receiving end of an FDA action. A federal judge in Miami just ordered the company to permanently cease offering certain types of injectable stem cell therapy.
The FDA claims that the clinic in Sunrise, Florida blinded multiple patients by injecting their eyes with a stem cell product. After the court issued the permanent injunction, the FDA issued the following statement:
Today’s action by Judge Ungaro is significant and sends a strong message to others manufacturing violative stem cell products. Court decisions like this reaffirm the FDA’s compliance and enforcement efforts in the ongoing fight to protect the public from individuals and clinics who mislead patients with unapproved and potentially harmful medical products. The agency will continue to take steps—such as issuing warning letters or initiating court cases— against those who endanger patients’ health with inadequate manufacturing conditions or by manufacturing and marketing products without the submission of appropriate applications containing safety and efficacy information to the FDA.
Stem cell products can be derived from a variety of materials. Sometimes companies use bone marrow, birth tissue or fat extracts. The product at issue with U.S. Stem Cell was derived from fat.
According to the Washington Post, one clinic patient visited with an ophthalmologist in 2015. Suffering from declining vision, the patient sought help from U.S. Stem Cell. There she was injected in both eyes with stem cells derived from fat in her belly. She suddenly went blind.
That same ophthalmologist reports a second patient who had similar therapy at the clinic also reported sudden blindness, this time accompanied by searing pain. That doctor reported the incidents to the FDA and urged an investigation.
It took almost four years for the FDA to act. Although the company stopped injecting stem cells into patients eyes after the patients sued, it continued offering other stem cell therapies. The company claims its stem cell products can help cure spinal injuries, Parkinson’s disease and multiple sclerosis.
Recently another patient who received stem cell therapy at a neighboring clinic associated with U.S. Stem Cell was rushed to the hospital after an injection for arthritis. She spent a month in a coma.
U.S. Stem Cell – Not a Fly by Night Operation
We are presently involved in many stem cell therapy cases. Most of the patients who received stem cells received them from tiny clinics employing questionable medical professionals and manufacturing practices.
U.S. Stem Cell claims it had almost $7 million in revenue and trains doctors nationwide. The clinic boasts some powerful political ties too. Apparently, that doesn’t make their products any safer than the others.
The CEO of the company, Kristin Comella, is also the president of the stem cell industry group Academy of Regenerative Practices. She claims that the FDA is trying to “crucify” her and has overstepped its bounds.
Clearly the Justice Department, FDA and court thought otherwise.
The company was not barred from offering products made from birth tissue and bone marrow. The company can apply to offer products made from fat tissue if it complies with a long list of conditions sought by the FDA and ordered by the court.
StemImmune Inc also an FDA Target
At the same time the FDA went after U.S. Stem Cell, it also filed suit against a California stem cell clinic, StemImmune. Court records suggest that case is even more disturbing.
StemImmune is a San Diego manufacturer of stem cell products. Its products are dispensed by the California Stem Cell Treatment Centers in Rancho Mirage and Beverly Hills.
U.S. Marshals seized seized five vials of live Vaccinia Virus Vaccine – a vaccine that is reserved only for people at high risk for smallpox. StemImmune was apparently using live small pox vaccine to create a stem cell vaccine not approved by the FDA. That product was then injected into cancer patients with potentially compromised immune systems and for whom the vaccine posed a potential for harm, including the possibility of inflammation and swelling of the heart and surrounding tissues.
Doctors were giving the product both by IV and directly into patients’ tumors. Given the unsterile conditions found by FDA inspections, the product could easily have proven fatal for a cancer patient with a compromised immune system.
The company was also creating unapproved stem cell products to treat arthritis, stroke, amyotrophic lateral sclerosis (ALS), multiple sclerosis (MS), macular degeneration, Parkinson’s disease, chronic obstructive pulmonary disease (COPD) and diabetes. The FDA has not approved any biological products manufactured by California Stem Cell Treatment Center for any use.
N.Y. Targets Stem Cell Clinics
It’s not just U.S. Stem Cell that finds itself under scrutiny. The FDA reportedly sent letters to 20 other clinics advising them they need to comply with FDA regulations.
In April, New York State sued Park Avenue Stem Cell and accused the company of engaging in fraudulent and illegal advertising. According to prosecutors,
“the clinic led vulnerable patients to believe it could treat a variety of serious medical conditions using the patients’ own stem cells, including, but not limited to: urological diseases, erectile dysfunction, cardiac/pulmonary disease, neurological diseases such as Parkinson’s disease and ALS, various autoimmune diseases such as lupus, and orthopedic conditions. While stem cells hold promise for future use, there is currently no adequate scientific substantiation that stem cells can effectively treat any of these conditions. Despite this, the Defendants charged consumers nearly $4,000 per procedure, with many consumers paying for multiple procedures.”
U.S. Stem Cell, Stem Cell Injuries and How to Recover Damages
Very few types of stem cell products have been approved by the FDA and even then, they are approved for a very few conditions or diseases. Like today’s CBD oil marketing claims, promoters are telling patients that stem cells can cure just about everything, apparently even a small penis.
The problem with stem cell therapy, many of the manufacturers do not follow FDA good manufacturing practices and many of the doctors offering the treatments aren’t properly trained. (We have seen dentists, chiropractors and even some folks with no doctoral degree dispensing these questionable therapies.
Injured patients have the right to file a stem cell lawsuit for financial compensation, including money to pay for past and future medical expenses, lost wages, pain and suffering, and other damages.
For more information, visit our stem cell injury claims information page. If you have information on potentially dangerous stem cell preparations or are ready to file a stem cell lawsuit, Contact us by email at *protected email*, by phone at 202-800-9791, or online. All inquiries are protected by the attorney – client privilege and kept confidential. We accept cases nationwide.
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