The need for regulatory measures regarding exosome therapy

In a newly published paper, Professor Misao Fujita (CiRA and ASHBi, Kyoto University), Senior Assistant Professor Taichi Hatta (Shizuoka Graduate University of Public Health), Dr. Tsunakuni Ikka (National Cancer Center Japan), and Lawyer Tatsuo Onishi (MLIP Law Office) have pointed out the necessity of clarifying regulations for medical interventions using exosomes.

In Japan, despite the lack of established scientific evidence, exosomes, and similar substances are already being provided as therapy. Additionally, due to the lack of proper tracking, adverse events cannot be accurately monitored. The publication of this paper is expected to raise awareness about the need for regulation regarding exosomes and promote the development of regulatory measures to ensure patient safety and facilitate research and development.

The research was published online in the international scientific journal “Stem Cell Reports” on October 24, 2024 (UTC).

For more detail, please refer CiRA website