Omotesando Helene Clinic's Research Paper on Long-term Safety After High-Dose Intravenous MSC Administration Published in International Academic Journal
Omotesando Helene Clinic announced the publication of a research paper in an international journal regarding the long-term safety of high-dose intravenous MSC administration. In an observational study using real-world clinical data from 2014 to 2023, no excess risk of major cardiovascular or cerebrovascular events was observed.
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- 📰 Published: May 25, 2026 at 21:43
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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.
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.
FAQ
表参道ヘレネクリニックが発表した研究論文の内容は何ですか？
高用量静脈内MSC（間葉系幹細胞）投与後の主要心血管・脳血管イベントの発生に関する、単施設の実臨床データを用いた後ろ向き観察研究です。
研究の結論はどうなっていますか？
観察対象集団において、高用量静脈内MSC投与後に主要心血管・脳血管イベントの明らかな過剰リスクを示す結果は認められなかったと報告されています。
対象となった期間とデータはどのようなものですか？
2014年1月から2023年12月までに静脈内MSC投与を受けた患者の診療記録を解析対象としています。
この研究の目的は何ですか？
治療効果を示すことではなく、実臨床データに基づき再生医療における長期安全性の評価に資する知見を提供することを目的としています。
掲載された学術誌名は何ですか？
国際学術誌 International Journal of Translational Medicine に掲載されました。