Omotesando Helene Clinic's Research Paper on Long-term Safety After High-Dose Intravenous MSC Administration Published in International Academic Journal

Omotesando Helene Clinic (located in Minato-ku, Tokyo) is pleased to announce that a research paper by our doctors Takaaki Matsuoka and Nana Kobayashi, titled "Cardiovascular Event Surveillance Following High-Dose Intravenous Mesenchymal Stem Cell Therapy: A Single-Center Real-World Observational Study," has been published in the international academic journal, International Journal of Translational Medicine.

While operating as an independent medical corporation, Omotesando Helene Clinic continues its academic activities to improve the quality and safety of regenerative medicine as the Tokyo clinical hub of the HELENE BIO Group's clinical, data, and R&D network.

HELENE BIO Group is a biopharmaceutical group that organically connects clinical practice, data, cell processing, and R&D in the field of cell therapy and ATMPs (Advanced Therapy Medicinal Products). As its Tokyo hub for clinical and real-world data generation, Omotesando Helene Clinic is committed to scientifically validating daily clinical experiences and disseminating findings that contribute to the development of regenerative medicine.

This study is a real-world retrospective observational study that examined the occurrence of Major Adverse Cardiac and Cerebrovascular Events (MACCE) following high-dose intravenous MSC (mesenchymal stem cell) administration using single-center real-world clinical data.

The study analyzed the medical records of patients who received intravenous MSC therapy between January 2014 and December 2023 to investigate long-term cardiovascular and cerebrovascular safety signals.

The paper reported that in the observed population, there was no evident excess risk of major cardiovascular or cerebrovascular events following high-dose intravenous MSC administration. On the other hand, the study notes that as it was a retrospective observational study with limited event counts, further large-scale prospective studies are necessary to evaluate long-term safety in greater detail.