Over the past decade, an unscrupulous stem cell industry that preys on vulnerable patients by offering modern-day snake oil has flourished. The number of clinics in the U.S. that peddle unproven stem cell “treatments” directly to consumers exploded from a handful in 2010 to as many as 570 in 2016.
Typically operated by for-profit companies, these clinics market stem cell injections for dozens of conditions, including Alzheimer’s disease, spinal cord injuries, autism, cerebral palsy, joint damage and heart disease. Some clinics even offer stem cell injections for cosmetic applications, such as facelifts and breast augmentation.
However, the vast majority of these potentially dangerous stem cell therapies have never been shown to be safe or effective in well-designed clinical trials. Moreover, the stem cells used by these clinics — which often are extracted from a patient’s own fat tissue — are considered to be drugs and biologic products under Food and Drug Administration (FDA) regulations, but the purveyors of these stem cell products, with few exceptions, have not obtained FDA approval to market them.
The FDA’s years-long failure to enforce regulations governing stem cell therapies emboldened for-profit stem cell clinics and fostered a regulatory environment characterized by some observers as a “Wild West” and a “Cowboy Culture.” But in late August, the FDA signaled that it finally may be willing to clamp down on the marketing of illegal stem cell treatments.
On August 28, 2017, the FDA called public attention to one of the most disturbing examples to date of stem cell clinics running amok: According to the agency, the California Stem Cell Treatment Centers in Rancho Mirage and Beverly Hills, California had injected vulnerable cancer patients with a “potentially dangerous and unproven” stem cell product that combined fat-tissue-derived stem cells with smallpox vaccine. The product belonged to StemImmune Inc. in San Diego, California.
Presumably because of the danger that StemImmune’s product posed to patients and others, U.S. Marshals — on behalf of the FDA — raided StemImmune on August 25 and seized several vials of the smallpox vaccine that StemImmune had been using to make its stem cell product. The FDA expressed “serious concerns” about how the company obtained the smallpox vaccine, which is not commercially available and is reserved only for people at high risk of smallpox, such as members of the military.
The vaccine contains live vaccinia virus, which is similar to the smallpox virus but generally does not cause serious illness in healthy people. According to The Washington Post, StemImmune “obtained at least some of the vaccine from the Centers for Disease Control and Prevention, which controls the civilian supply.”
Because cancer patients often have compromised immune systems, they are susceptible to serious, sometimes life-threatening complications from receiving live vaccinia virus, including myocarditis and pericarditis (inflammation and swelling of the heart and the tissues surrounding the heart). Moreover, these same health problems also can occur in people who have been accidentally infected with the vaccinia virus due to close contact with someone who has received the smallpox vaccine. Pregnant women and patients with heart disease, immune disorders or skin problems like eczema or psoriasis are at greatest risk.
The FDA also announced on August 28 that, four days earlier, the agency had issued a warning letter to US Stem Cell Clinic in Sunrise, Florida for illegally marketing stem cell products derived from patients’ fat tissue. The violations cited in the FDA’s warning letter were uncovered by agency inspectors in May to April of this year. The company had promoted its stem cell therapies for a variety of diseases, including Parkinson’s disease, diabetes and chronic obstructive pulmonary disease. The agency publicly declared that US Stem Cell Clinic had marketed stem cell products “without FDA approval” and had deviated significantly “from current good manufacturing practice requirements, including some that could impact the sterility of their products, putting patients at risk.”
The FDA also cited US Stem Cell Clinic’s chief scientific officer, Ms. Kristin Comella, for trying to impede the FDA’s inspection by refusing to permit FDA inspectors to enter the clinic except by appointment and denying them access to company employees.
The Washington Post reported that US Stem Cell Clinic was the subject of a March 2017 article in the New England Journal of Medicine that had described three patients who suffered severe vision loss following injections of fat-derived stem cells into their eyeballs for age-related macular degeneration.
Although the belated enforcement actions taken by the FDA in August are a welcome step, FDA Commissioner Scott Gottlieb irresponsibly misrepresented the scope of the problem when he stated the following:
“There are a small number of unscrupulous actors who have seized on the clinical promise of regenerative medicine, while exploiting the uncertainty, in order to make deceptive, and sometimes corrupt, assurances to patients based on unproven and, in some cases, dangerously dubious products… In such an environment a select few, often motivated by greed without regard to responsible patient care, are able to promote unproven, clearly illegal, and often expensive treatments that offer little hope, and, even worse, may pose significant risks to the health and safety of vulnerable patients.” [Emphasis added]
Contrary to Gottlieb’s assertion, StemImmune, California Stem Cell Treatment Centers and US Stem Cell Clinic represent only the tip of the iceberg in this troubling industry. The FDA must relentlessly pursue and shut down the hundreds of stem cell clinics across the U.S. that threaten patients’ health by marketing unsafe and unproven products.