A lack of oversight for unproven stem cell interventions is a global public health problem

Jun 4 2021

In a recent Stem Cell Reports paper, the authors urge the World Health Organization (WHO) to establish an Exert Advisory Committee on Regenerative Medicine to provide harmony to the national regulations on the stem cell intervention (SCI) industry. Furthermore, the authors discuss the importance of developing an education campaign to tackle misinformation surrounding stem cell products.

Stem Cell Therapy. Image Credit: gwolters/Shutterstock.com

The dangers of an unproven SCI industry

The unproven SCI industry describes the global direct-to-consumer market where stem cells, as well as various stem and non-stem cell-derived components with little to no scientific basis, are administered to patients in a clinical setting. These practices highly dangerous and have already led to multiple patient injuries and deaths.

Furthermore, the clinical use of these SCI products threatens legitimate research efforts and undermines the regulatory authorities throughout the world that should be protecting the public from these potentially dangerous products.  

The current state of regenerative medicine

By definition, regenerative medicine is a branch of research that involves the generation, manipulation, and clinical application of therapeutic stem cells and tissues. With the primary goal of using these therapies to treat non-communicable diseases, a significant amount of both public and private investments has been devoted to regenerative medicine. In fact, this global market, which is valued at approximately $13 billion, accounts for over 1,200 cell and gene therapy trials, most of which are currently in early-phase clinical research stages.

The promising future of regenerative medicine in treating chronic diseases has led to a sharp rise in false claims surrounding the health benefits of these therapies. Some clinics around the world are monopolizing on these unsubstantiated claims to market that unproven SCIs are available. An additional problem is that many are considering or have already loosened their regulatory standards on SCIs to gain an economic advantage in the global SCI market.

European, North American, and Southeast Asian countries, as well as Australia, are home to clinics that have purported SCIs. The unproven SCI market has an estimated value of $2.4 billion, with about 60,000 individuals who are impacted by these claims each year.

The limits of national efforts to combat unproven SCIs

Although several efforts have been made by the regulatory agencies in individual nations to combat the misinformation and illegal administration of SCIs, their effectiveness has been limited in stifling this massive market. Within the United States, several different regulatory bodies have successfully reduced the marketing of unproven SCIs.

Between 2015 and 2018, unproven SCI clinics in the United States rose from 570 to about 1,000. To curb the expansion of these unproven treatment locations, the United States Food and Drug Administration (FDA) updated its guidance on cell-based therapies to now be regulated as a drug, device, and/or biologic.

Although several SCI clinics have been successfully shut down by the FDA, this regulatory agency has limited capacity. This is largely due to the fact that approximately 70% of SCI clinics in the United States have one to three practitioners, of which about 40% are solo practices. This expansive market within the United States, therefore, limits the ability of a single agency like the FDA to tackle every single clinic that is advertising unproven SCIs.

I believe that the global spread of unproven stem cell therapies reflects critical gaps in the international system for responding to health crises, which could put the lives of thousands of patients in danger. Urgent measures are needed to enhance the global regulatory capacity to detect and respond to this eminent crisis rapidly,”

Abou-El-Enein, one of the lead authors of the Stem Cell Reports paper

Expanding the WHO’s role

As compared to national public health efforts, global health policy has a greater impact on enforcing international strategies and harmonization efforts to mitigate the problems associated with the unproven SCI market. As defined in its constitution, the WHO has the authority to establish international collaborations, assist governments in achieving public health-related goals, provide recommendations and technical guidance, and improve global health standards.

The widespread influence of the WHO on international health matters was particularly evident during the coronavirus disease 2019 (COVID-19) pandemic, as well as several other humanitarian crises. Once human genome editing became a validated technology, the WHO announced the establishment of an expert panel on human genome editing in 2018 known as the Expert Advisory Committee (EAC) on Human Genome Editing. This panel was charged with reviewing the current literature on research involving this technology, consider existing proposals on governing human genome editing and its applications, as well as solicit findings of public attitudes towards the use of this technology.

By developing a similar EAC on regenerative medicine, the WHO could standardize the regulatory definitions and practices of this scientific field, support the development of safe and effective cell-based therapies to treat patients’ unmet medical needs, and ensure the protection of participants when SCIs enter human trials. Furthermore, this type of panel would have the platform that is desperately needed to address the substantial amount of misinformation that is currently circulating throughout the world on the SCI industry.