Clinics providing exosome therapies assert that they can mend and regenerate tissues, as well as address inflammatory and other immune-related ailments through noninvasive methods. However, a group of bioethicists and legal scholars from Japan is warning about the critical need for stricter regulations concerning these unverified treatments. Their concerns were published on October 24 in the journal Stem Cell Reports.
Clinics specializing in exosome therapies assert that they have the capability to repair and rejuvenate tissues and manage inflammatory and immune-related issues without invasive procedures. Nevertheless, a consortium of bioethicists and legal experts from Japan is raising alarms regarding the pressing requirement for enhanced regulations on these unsubstantiated interventions. Their letter was published on October 24 in Stem Cell Reports.
“Administering these treatments to patients without empirical evidence or an established regulatory framework carries significant risks,” stated Misao Fujita, the lead author and a professor at Kyoto University. “Our article emphasizes that the absence of regulation has resulted in unsafe medical practices and highlights the need to establish clear regulations to safeguard patients while promoting research in these areas.”
Exosomes are a kind of extracellular vesicle that plays a crucial role in cell communication. Like many unproven treatments associated with stem cells, exosome therapies are marketed for various ailments, including hair loss, degenerative diseases, and inflammation related to heart disease and other serious health issues. Some clinics provide both stem cell and exosome treatments, often at a steep cost for patients. In the United States and the European Union, exosome treatments are categorized as biological products and must undergo safety evaluations before being offered to patients. Nonetheless, no exosome therapies have currently received approval based on clinical effectiveness, and these procedures can potentially cause serious harm to individuals.
In Japan, the absence of definitive regulations for these products has made tracking and reporting adverse events challenging, which increases patient risks, according to Fujita. “There have been reports in the media regarding patient fatalities and severe complications, yet there is no national system for accurately monitoring or assessing these events,” she explained. “We believe that addressing these issues collaboratively on a global scale is vital for identifying solutions that ensure patient safety.”
The authors aspire for their findings to resonate with scientists interested in the medicinal uses of stem cells and exosomes, as well as researchers and policymakers engaged in bioethics and the development of regulatory frameworks. They also aim to bring this matter to the forefront for healthcare professionals and industry figures who are involved in providing these treatments.
Looking ahead, the team intends to enhance their research in this field and persist in raising public consciousness among both professionals and the general population.
