[Editor’s note: Dr. Gorski is once again too busy with another looming grant deadline to provide a new post. Fortunately, some interesting stem cell events provided Dr. David Weinberg with a good news story he’d like to share with us.]
An SBM article last year described three women who sought treatment for macular degeneration at a stem cell clinic in Florida. Each woman underwent liposuction. The liposuction material was processed, mixed with platelet-rich plasma derived from their own blood, and injected into both of their eyes. Things quickly deteriorated. Each woman rapidly lost vision in both eyes to the point or legal blindness. In the most extreme case, one woman lost all ability to perceive light in both eyes.
A second article provided additional information about the company (U.S. Stem Cell, formerly Bioheart) and its Chief Scientific Officer, Kristin Comella. The Company claims to be a “World leader in research and development of stem cell and regenerative medicine treatments” but SEC filings reveal that in 2017 and 2018 they spent a paltry .1% of operating expenses on research and development. Emblematic of their posturing toward research, they had previously announced plans to perform a clinical trial to study adipose derived stem cell treatment of macular degeneration, but abandoned the study before enrolling a single patient. Despite the lack of data to establish the safety and efficacy of this treatment, for $5,000 each, they sold this treatment to the three aforementioned women, with tragic results.
Kristin Comella, the Chief Scientific Officer and very much the public face and voice of the company, has a Ph.D in Stem Cell Biology. It is noteworthy that she earned this degree only after she held the Chief Scientific Officer position for several years. Prior to that, her highest degree was a M.S. in chemical engineering. It is equally noteworthy that her Ph.D was awarded by the Panama College of Cell Science, an unaccredited offshore virtual college that hands out PhD degrees in 3 years for tuition of $2,950/year ($2,700 if paid in advance).
U.S. Stem Cell and Dr. Comella sold and promoted adipose derived stem cell treatment for an astounding variety of maladies with little more than anecdotal evidence. They sold the treatment in their own clinics, and also operated a business teaching other healthcare professionals how to perform the treatments.
U.S. Stem Cell’s activities earned the attention of the FDA. In 2017 the FDA inspected their facility in Sunrise Florida. They declared that the treatments that U.S Stem Cell was performing amounted to the illegal marketing of an unapproved drug, and that they were in violation of numerous statutes regulating the production of this drug. The infractions were enumerated in a warning letter.
In order to continue their practices legally, they would need to perform a lengthy and expensive process of clinical trials, and if proven safe and effective, they could then submit a Biologic Licensing Application (BLA). If approved they could then legally produce and sell their product.
Rather than cease operations and comply with the FDA warning letter, U.S. Stem Cell argued that the FDA had “wrongly defined these in clinic procedures as a drug” and opined that “If the federal government were to interfere with a person’s ability to obtain and utilize their own cells in their body to heal themselves, this could be a gross violation of the constitution”. They continued to treat patients in defiance of the FDA directives.
Based on the lack of response to their warning letter, on May 9, 2018 the FDA went to federal court seeking permanent injunctions against U.S. Stem Cell and another West Coast stem cell network. U.S. Stem Cell remained defiant and vowed to “vigorously defend a lawsuit filed today by the U.S. Department of Justice at the request of the U.S. Food and Drug Administration (FDA).”
The FDA is an executive agency under the Department of Health and Human Services. The Food Drug and Cosmetics Act of 1938 increased federal oversight of drugs. Congress has delegated certain regulatory responsibility to the FDA. Rules and regulations written by the FDA are codified in the Code of Federal Regulations (CFR). The FDA has asserted authority over certain aspects of stem cell treatment, and has made efforts to clarify the regulations in this new technology. Until recently, they have done very little to intervene against individual providers of so-called gray market in stem cells. For many critics of the retail stem cell industry, the FDA warning letter and subsequent legal proceedings against specific stem cell providers is a welcome and promising turn of events. Since filed in May 2019, interested parties on all sides of the stem cell controversy have been awaiting the results of the legal proceedings.
On June 3, 2019 a judge of the Southern District of Florida upheld the FDA’s injunctions against U.S. Stem Cell. I could not find an official statement from U.S. Stem Cell, but a New York Times article refers to a correspondence by Kristen Comella, Chief Scientific Officer: “While we believe there is substantial evidence to prove the efficacy of this protocol, we must immediately comply with the court as we review the decision”.
Sadly, it is too late to protect the women blinded by the by treatment they received at U.S. Stem Cell, but this is a favorable decision for those of us who have been critical of the growing stem cell industry. This is one ruling regarding one type of treatment at one specific clinic, but has far-reaching implications. Hopefully, it signals a greater visibility of the FDA in asserting its authority to protect consumers. It affirms that, contrary to the protests of U.S. Stem Cell, the FDA is acting within its jurisdiction in regulating certain aspects of the stem cell industry.
Other stem cell clinics using adipose-derived stem cells would be wise to re-evaluate their business practices. The implications for this ruling would seem to extend beyond the use of cells derived from adipose tissue, so this represents a threat to many other retail stem cell providers.
The ink is barely dry on this court ruling and the consequences remain unknown. Given the facts of the case, this seems like the best outcome. It is unknown if U.S. Stem Cell will appeal this decision.