It's a nightmare story: Three women pay tens of thousands of dollars to a South Florida clinic for unproven "stem cell therapy," only to end up blind. At least one thought she was part of a clinical trial—undergoing an experimental treatment, certainly, but presumably with adequate safeguards. Instead, the women found themselves in a much murkier situation, receiving dubious treatment at a clinic that was almost entirely unregulated. The results, in this case, speak for themselves, and critics warn that there's a large and growing problem with patients being promised revolutionary "stem cell therapy," only to find they've wasted their money—or worse.
Their costly, unproven treatments can be risky. But for-profit stem cell clinics are flourishing.
The F.D.A. has taken an industry-friendly approach toward companies using unproven cell cocktails to treat people desperate for relief from aging or damaged joints.
Rogue stem cell clinics continue to victimize hopeful patients seeking cures for cancer, Parkinson’s disease, autism, chronic pain, and more.
Most of these treatments are unproven and unsupported by evidence, wasting precious time and health care dollars for desperate patients and often doing more harm than good to patients’ health and survival.
Many therapeutic developers are exploring the potential utility of stem cell therapies in a number of disease areas; however, very few have been granted approval by governmental regulatory agencies for commercial use.
At the same time, a growing number of “stem cell clinics” are taking advantage of the “hype” around stem cells and avoiding regulation by falsely marketing illegal and potentially harmful products to patients seeking cures for diseases, including the novel COVID-19 (coronavirus).
Stem-cell clinics that offer seeming miracle cures for everything from back pain to erectile dysfunction have proliferated in the United States in the past decade. These cases of blindness now cropping up in the medical literature point to the potential dangers of letting hundreds of such clinics operate without oversight.
The Food and Drug Administration has launched an opening salvo at a booming national market for suspect medical treatments, announcing actions that could rein in clinics offering questionable stem-cell treatments for cancer and other diseases.
There is still a lot to learn about stem cells, however, and their current applications as treatments are sometimes exaggerated by the media and other parties who do not fully understand the science and current limitations, and also by “clinics” looking to capitalize on the hype by selling treatments to chronically ill or seriously injured patients.
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.
Cell therapies hold significant promise for the treatment of injured or diseased musculoskeletal tissues. However, despite advances in research, there is growing concern about the increasing number of clinical centres around the world that are making unwarranted claims or are performing risky biological procedures.
The problem is that stem cell therapies are still mostly theory. So what is going on? How can there be clinics, even chains of clinics run by companies, offering stem cell treatment for almost any disease you can think of — sports injuries, arthritis, autism, cerebral palsy, stroke, muscular dystrophy, A.L.S., cancer?
Was the promise of stem cells overstated?
In some ways, yes, it is overstated. For example, target diseases for cell therapy are limited. There are about 10: Parkinson’s, retinal and corneal diseases, heart and liver failure, diabetes and only a few more — spinal cord injury, joint disorders and some blood disorders. But maybe that’s all.
570 sites advertise therapies for sports injuries, autism and MS via direct-to-consumer marketing.
Patients are promised revolutionary therapy, only to find they’ve wasted their money—or worse.