Report Warns About Manipulated And Faked Research On Usage Of Stem Cells To Treat COVID-19. Be Careful Of Clinics Offering Stem Cell Treatments
A new study by researchers from University of California, Irvine-USA, University of Melbourne-Australia, Georgia Institute of Technology-USA and The State University of New York warns about the misinformation linked to ‘overhyped science’ on stem cell treatments for COVID-19.
Many previously published studies on stem cells claiming to be able to prevent or treat COVID-19 or Long COVID or even boost the immune system were basically substandard research and in some cases contains manipulated or faked study findings or clinical trial data, a common practice in countries like India, China, Mexico and Brazil.
Individuals are also advised to be wary of clinics or ‘experts’ promoting the usage of stem cell therapies
to treat COVID-19 or Long COVID or are making claims that stem cells boost the immunity system. Consumers in America can make complaints directly to the U.S, FDA while consumers in Thailand can make complaints to the consumer board and those in other countries are advised to contact your respective regulatory agencies to register your complains.
The study team stated in their abstract, “The significant morbidity and mortality of COVID-19 prompted a global race to develop new therapies. These include interventions using cell- or cell-derived products, several of which are being tested in well-designed, properly controlled clinical trials. Yet, the search for cell-based COVID-19 treatments has also been fraught with hyperbolic claims; flouting of crucial regulatory, scientific, and ethical norms; and distorted communication of research findings. In this paper, we critically examine ethical issues and public communication challenges related to the development of cell-based therapeutics for COVID-19. Drawing on the lessons learned from this ongoing process, we argue against the rushed development of cell-based interventions. We conclude by outlining ways to improve the ethical conduct of cell-based clinical investigations and public communication of therapeutic claims.”
The report was published in the peer reviewed journal: Stem Cell Reports. https://www.cell.com/stem-cell-reports/fulltext/S2213-6711(21)00481-1
Sadly, it has been found that the global race to develop new stem cell-based COVID-19 treatments during the pandemic was filled with violations of government regulations, inflated medical claims and distorted public communication, say the study team.
Although stem cell therapy ie using stem cells to promote regeneration, repair or healing, may be used to treat a limited number of diseases and conditions, there are currently no clinically tested or government-approved cell therapies available for the treatment or prevention of COVID-19 or its long-term effects.
But this has not stopped the emergence of unethical ‘experts’ and clinics offering unproven and unsafe "stem cell" therapies that promise to prevent COVID-19 by strengthening the immune system or improving overall health, says lead researcher Dr Laertis Ikonomou, Ph.D., associate professor of oral biology in the University at Buffalo School of Dental Medicine.
The report explores the negativ
e effects that misinformation about cell therapies has on public health, as well as the roles that researchers, science communicators and regulatory agencies should play in curbing the spread of inaccurate information and in promoting responsible, accurate communication of research findings.
Dr Ikonomou,"Efforts to rapidly develop therapeutic interventions should never occur at the expense of the ethical and scientific standards that are at the heart of responsible clinical research and innovation.”
Co-author Dr Leigh Turner, Ph.D., professor of health, society and behavior at the University of California, Irvine added, “Scientists, regulators and policymakers must guard against the proliferation of poorly designed, underpowered and duplicative studies that are launched with undue haste because of the pandemic, but are unlikely to provide convincing, clinically meaningful safety and efficacy data."
The other reserachers in the study team include Dr Megan Munsie, Ph.D., professor of ethics, education and policy in stem cell science at the University of Melbourne; and Dr Aaron Levine, Ph.D., associate professor of public policy at Georgia Institute of Technology.
To date, many of the studies on possible stem cell-based COVID-19 treatments are at an early stage of investigation and further evaluation on larger sample sizes is required, says Dr Munsie. However, the findings from preliminary studies are frequently exaggerated through press releases, social media and uncritical news media reports.
Dr Levine added, "Given the urgency of the ongoing pandemic, even the smallest morsel of COVID-19 science is often deemed newsworthy and rapidly enters a social media landscape where regardless of its accuracy, it can be widely shared with a global audience.”
D Turner warned, “Clinics selling supposed stem cell treatments on a direct-to-consumer basis sometimes use these findings and news reports to exploit the fears of vulnerable patients by unethically advertising the unproven benefits of stem cell treatments to boost the immune system, regenerate lung tissue and prevent transmission of COVID-19.”
Alarmingly there are reports of patients suffering physical harm including blindness and death from unproven stem cell therapies.
Many patients suffer financially as well, says Dr Ikonomou, as the products range in price from a few thousand to tens of thousands of dollars, and people are often encouraged to receive the expensive treatments every few months.
Many patients led to believe they are protected against COVID-19 may decide against vaccination, stop wearing masks, cease engaging in physical distancing, or otherwise avoid behaviors intended to promote personal safety and public health, says Dr Turner.
They may also become less likely to take part in carefully-developed clinical trials conducted by companies that follow ethical standards.
Dr Ikonomou added, "The premature commercialization of cell-based therapeutics will inevitably harm the field of regenerative medicine, increase risks to patients and erode the public's trust.”
The U.S. Food and Drug Administration and Federal Trade Commission have issued warnings to numerous offending clinics, yet many companies continue to make false claims.
The study team recommend that regulatory agencies consider implementing stronger measures to deter the sale of unlicensed products, such as issuing fines or criminal charges, revoking medical licenses or forcing clinics to return money to patients.
The study team also suggest that scientific and professional societies lobby regulatory agencies to increase enforcement of laws and regulations.
Science communicators and journalists can combat misinformation by not engaging in hyperbolic coverage of research results and conveying study limitations, say the authors.
Thailand Medical News would like to add that in Thailand, there are many called greedy private clinics and even hospitals that allow foreigners who claim to medical practitioners but are not licensed by the local Thai Medical Council to recommend and even administer stem cell therapies or other garbage and unproven or unapproved protocols such as special antioxidant IV drips etc. Also when it comes to certain doctors peddling such stem cell therapies, be even more wary as most do not have sufficent product or medical knowledge about the usage of stem cells, always check their qualifications and speciality. Consumers are advised to report to the local consumer boards even if you had such therapies in the past or contact us for help to access proper legal recourse.
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