Doctors at Omotesando Helene Clinic Publish New Study on Long-Term Safety Surveillance Following High-Dose Intravenous MSC Administration

Continuing clinical data analysis and academic publication in regenerative medicine and ATMP as the Tokyo clinical hub within Helene Bio Group

TOKYO, May 29, 2026 /PRNewswire/ -- Medical Corporation HELENE Omotesando Helene Clinic, located in Minato-ku, Tokyo, is pleased to announce that a research paper authored by its physicians, Dr. Takaaki Matsuoka and Dr. Nana Kobayashi, has been published in the international academic journal International Journal of Translational Medicine.

The paper, titled "Cardiovascular Event Surveillance Following High-Dose Intravenous Mesenchymal Stem Cell Therapy: A Single-Center Real-World Observational Study," examines the incidence of major adverse cardiac and cerebrovascular events, or MACCE, following high-dose intravenous MSC administration using real-world clinical data from a single center.

Omotesando Helene Clinic provides medical care as an independently managed Japanese medical corporation. At the same time, it is positioned as the Tokyo clinical hub within the clinical, data, and research and development network of Helene Bio Group.

Helene Bio Group is a biopharmaceutical group engaged in cell therapies and ATMP, or Advanced Therapy Medicinal Products, by integrating clinical practice, data generation, cell processing, and therapeutic development. As the Tokyo clinical and real-world data generation hub within this broader network, Omotesando Helene Clinic continues to review and analyze clinical data and share academic findings that contribute to the responsible development of regenerative medicine.

For clarity, references in this release to Omotesando Helene Clinic as a "Tokyo clinical hub within Helene Bio Group" or as part of the group's clinical and data network do not imply ownership, management control, or involvement in medical practice by any stock company or non-medical corporation. Omotesando Helene Clinic provides medical services independently as a Japanese medical corporation in accordance with applicable Japanese laws and regulations.

About the Study

This study is a single-center, retrospective, real-world observational study evaluating the incidence of major adverse cardiac and cerebrovascular events, or MACCE, following high-dose intravenous MSC administration.

The study retrospectively reviewed clinical records of patients who received intravenous MSC administration between January 2014 and December 2023, with a focus on long-term cardiovascular and cerebrovascular safety signals.

The paper reports that, within the observed cohort, high-dose intravenous MSC administration was not associated with an apparent excess risk of major adverse cardiac or cerebrovascular events. At the same time, the authors note that the study was retrospective in design and that the number of observed events was limited. Larger prospective studies will therefore be required to further characterize the long-term safety profile of MSC-based interventions.

The study was designed to evaluate safety signals and was not intended to establish therapeutic efficacy.

Paper Information

Title
Cardiovascular Event Surveillance Following High-Dose Intravenous Mesenchymal Stem Cell Therapy: A Single-Center Real-World Observational Study

Authors
Dr. Takaaki Matsuoka and Dr. Nana Kobayashi
Omotesando Helene Clinic

Journal
International Journal of Translational Medicine

Publication Date
30 March 2026

DOI
10.3390/ijtm6020015

Physician Comment

Dr. Takaaki Matsuoka commented:

"At Omotesando Helene Clinic, we place great importance not only on accumulating clinical experience, but also on carefully reviewing and analyzing the data obtained through clinical practice in order to improve the quality and safety of the medical care we provide. The publication of this paper represents one part of our ongoing commitment as a medical institution engaged in regenerative medicine.

As the Tokyo clinical hub within Helene Bio Group, we will continue to organize clinically grounded insights in a scientific manner and share academic findings that contribute to the development of regenerative medicine and the broader ATMP field."

Academic Activities at Omotesando Helene Clinic

Omotesando Helene Clinic has continued to engage in academic activities in the field of regenerative medicine, including research publications, clinical data analysis, and presentations at domestic and international conferences.

The clinic has previously shared academic work related to MSCs, cell culture technologies, exosomes, safety evaluation, and quality-of-life assessment. Through these activities, Omotesando Helene Clinic aims to continue strengthening the scientific foundation of its clinical practice and further improve the quality and safety of the care it provides to patients.

About Helene Bio Group

Helene Bio Group is a biopharmaceutical group engaged in cell therapies and ATMP by integrating clinical practice, data generation, cell processing, and therapeutic development. Through its clinical and research and development network across Japan, the United Kingdom, the United Arab Emirates, and other regions, Helene Bio Group aims to connect clinical insights with cell therapy development, quality control, standardization, and future regulatory pathways.

Omotesando Helene Clinic serves as the Tokyo clinical hub within this network, contributing clinical experience, patient follow-up, real-world data generation, and academic publication in the field of regenerative medicine.

About Medical Corporation HELENE Omotesando Helene Clinic

Medical Corporation HELENE Omotesando Helene Clinic is a medical institution located in Minami-Aoyama, Minato-ku, Tokyo, engaged in regenerative medicine. The clinic provides regenerative medicine using autologous adipose tissue-derived MSCs and continues to pursue improvements in cell processing, quality control, safety evaluation, and clinical data analysis.

The clinic remains committed to responsible academic communication and to contributing to the advancement of regenerative medicine through both clinical practice and research.

Media Contact

Medical Corporation HELENE, Omotesando Helene Clinic
Contact Person: Harry Shin
Email: [email protected] 
Tel: +81-3-6433-5409

SOURCE Medical Corporation HELENE Omotesando Helene Clinic