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Caveat: Stem cells touted for coronavirus treatments

29 June 2020
By Dr Patrick Foong
Law Lecturer, Western Sydney University, Australia
Appeared in BioNews 1053

This unprecedented challenging time has seen the emergence of unproven stem cell-based therapies for the novel coronavirus, SARS-CoV-2. Stem cell therapy is a promising path for the development of new treatments for a number of devastating diseases such as Parkinson's disease and heart disease, and may yet be promising in the fight against the coronavirus, although currently no stem cell treatment for the coronavirus has been proven safe or effective under well-designed and rigorously conducted clinical trials.

During this pandemic, it is crucial to provide the population with evidence-based therapies for COVID-19, the disease caused by SARS-CoV-2, not unproven products promoted as cures. By making it appear that reliable clinical studies have validated stem cell treatments, businesses are misinforming the general public. All new drug therapies, including cell-based therapies, must first be thoroughly investigated in controlled clinical trials. Conducting these trials will determine whether there is reliable and substantial evidence that supports using stem cell products as safe and established treatments for COVID-19.  

Much research is currently in progress, such as clinical trials using mesenchymal stem cells. Unfortunately, these preliminary studies are simply insufficient to support commercialising these interventions at this time.

In a recent study in the US, bioethicist Dr Leigh Turner from the University of Minnesota raises his concerns over these purported stem-cell-based therapies. He was apprehensive that anyone buying these so-called preventative measures or treatments for COVID-19 would be harmed as a result of using products that have not been thoroughly verified. He was also worried that they might abstain from taking specific crucial steps, such as social distancing, when they believe the product they have purchased will protect them from being infected with the coronavirus.  

As an example, Dr Turner mentions a clinic based in Colorado, which advertised 'mesenchymal stem cell exomes' as a 'viral inhibitor and immune system booster.' The costs for the procedure are US $3000 for an individual, US $2700 each for two family members and US $2200 per person for three or more family members. Moreover, clinics are cropping up all over the United States, including Alabama, Arizona, California, Delaware, Florida and Pennsylvania that are selling similar products. Some of them were promoting stem cell therapy as a precautionary step to not become infected with the coronavirus, while others claim it can repair the harm caused by COVID-19. There are also clinics advertising 'biobanking' where you can store autologous stem cells (your own stem cells) for future use if needed. The storage fee is very costly and successful treatment for COVID-19 is not guaranteed. A clinic in Alabama claimed on their Facebook page 'We have the option of providing patients with immediate (point of care) of stromal vascular fraction (SVF), which is stem cells produced from your own fat that are used on the same day and/or the option of having mini liposuction and then banking your own adipose stem cells for expansion into very high numbers.'

Professional societies, such as the International Society for Stem Cell Research (ISSCR) have warned that such advertising is ethically and morally irresponsible since there are no proven stem cell therapies for the prevention or the treatment of the coronavirus at present.  

But such warnings are not enough. It is vital that government regulatory groups, such as the Food and Drug Administration (FDA) step up enforcement. The FDA has sent warning letters to companies providing COVID-19 treatments, including one company based in Perth, Western Australia where they were alleged to be advertising unsafe products. The FDA has also issued 'untitled letters' to clinics promoting untested stem cell interventions (these letters are issued for breaches that do not fulfil the threshold of regulatory significance for a warning letter).  

Another regulatory agency, the Federal Trade Commission (FTC), has issued warning letters to more clinics to cease claiming that their products can treat or prevent COVID-19. Previously, the agency posted similar letters to more than 160 individuals and corporations. These letters direct the clinics to immediately cease making these claims and the clinics are required to inform the Commission within 48 hours about the specific steps they have decided to pursue to address the agency's concerns. The letters warn that if the false claims do not stop, the Commission may obtain a court injunction and also a court order that compels a refund to be made to the consumers.

Recently, the Therapeutic Goods Authority (TGA) in Australia strengthened its law on advertising stem cell products to consumers. Currently, the only approved use of stem cells in Australia is haematopoietic stem cell transplants for cancers, autoimmune conditions and blood disorders.  

Stringent enforcement measures are indeed essential. The regulatory bodies must clamp down on these deceitful clinics preying on public panic. Misleading the public on the efficacy of these so-called stem cell treatments amounts to misrepresentation. 

SOURCES & REFERENCES
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HAVE YOUR SAY
Comment (User:150575 - 30/06/2020)
Dr. Foong,

I would like to thank you for your commentsry. I have written on this topic for quite some time, including a piece detailing my own experience receiving SCT in Nanjing, China in 2010. I invite you to read my writing which can be found in my online portfolio. It is written from both the perspectives of a patient and a policy analyst. I believe this issue to be not only one of medical and scientific importance, but one that resides at the foundation of civil rights, disability rights and health democracy.

I agree with you that ethical marketing practices in SCT are indispensable to safeguarding the health of patients, although I do wholeheartedly believe that even with enhanced enforcement efforts, the prevalence of adverse events is marginal, especially when compared to surgery and pills. I also agree that due diligence on the part of patients seeking SCT is critical. Flagrant and deceptive marketing practices can be found in any industry, and those businesses found to have engaged in such practices should indeed be subject to sanctions commensurate with the legal transgression

That said, ultimately, any increase in the regulation of stem cell clinics must be undertaken judiciously, deliberately and thoughtfully; must be narrowly tailored and narrowly targeted toward the twin goals of patient safety and information dissemination; must be the least restrictive means of achieving those goals; and must always be pursued with an eye toward ensuring the maximum availability of these potentially life-saving therapies..Any regulation beyond these standards would be unduly-burdensome, excessive, unnecessary and quite possibly deleterious.

Thanks again. Dr. A. Rahman Ford, JD, PhD
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