Experts call for clear and concise regulation of exosome-based treatments

Clinics that offer exosome therapies claim they have the ability to repair and regenerate tissues and treat inflammatory and other immune-related conditions in a noninvasive way. Now, a team of bioethicists and legal scholars from Japan is sounding the alarm on the urgent need for stronger regulations surrounding these unproven interventions. Their letter appears October 24 in the journal Stem Cell Reports.

“Administering these treatments to patients without scientific evidence or a clear regulatory framework involves significant risks,” says first author Misao Fujita, a professor at Kyoto University. “Our paper highlights how the lack of regulation has led to unsafe medical practices and stresses the importance of clarifying regulations both to protect patients and foster the development of research on these products.”

Exosomes are a type of extracellular vesicle responsible for intercellular communication. Similar to unproven stem cell-based interventions, exosome therapies are promoted as treatments for a range of conditions, from hair loss to degenerative diseases to inflammation related to cardiovascular disease and other serious conditions. Some clinics offer both stem cell- and exosome-based interventions, often at a significant financial cost to patients. In the United States and the European Union, exosome treatments are regulated as biological products and require safety review before being administered to patients. To date, however, there are no therapies using exosomes that have been approved based on clinical efficacy, and these interventions can cause serious harm to the human body.

In Japan, where there is no clear regulation of these products, it is difficult to even track and report adverse events, further increasing the risk to patients, Fujita says. “There have been media reports covering patient deaths and severe complications, but there is no national system in place to accurate track or assess these incidents,” she adds. “We believe that sharing this problem and collaborating globally is the way to find solutions that are essential for ensuring patient safety.”

The authors hope their paper will reach scientists interested in the medical applications of stem cells and exosomes, as well as researchers and policymakers focused on bioethics and building regulatory frameworks. They also want to raise these issues among the healthcare professionals and industry stakeholders who are involved in offering these interventions to patients.

Moving forward, the team plans to deepen their research in this area and continue to raise public awareness among both professionals and members of the public.

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This study was funded by the Japan Society for the Promotion of Science and the Uehiro Foundation on Ethics and Education. Declarations of interest are provided in the manuscript.

Stem Cell Reports, Fujita et al. “The urgent need for clear and concise regulations on exosome-based interventions” https://www.cell.com/stem-cell-reports/fulltext/S2213-6711(24)00270-4 

Stem Cell Reports (@stemcellreports), published by Cell Press for the International Society for Stem Cell Research (@ISSCR), is a monthly open-access peer-reviewed publication communicating basic discoveries across the spectrum of stem cell research and translational and clinical studies. The journal focuses on shorter, single-point manuscripts that report original research with conceptual or practical advances that are of broad interest to scientists and clinicians across the continuum of stem cell science and application. Visit http://www.cell.com/stem-cell-reports. To receive Cell Press media alerts, please contact press@cell.com.