Pioneering Clinical Trial Demonstrates Safety and Functional Improvement of Intravenous Allogeneic Stem Cell Therapy in Acute Myocardial Infarction

Myocardial infarction (heart attack) remains one of the leading causes of death globally. With Taiwan entering an aging society, cardiovascular disease has become a growing focus of medical attention. While current pharmacological and interventional treatments have advanced significantly, restoring cardiac function after a heart attack continues to be a major challenge. Honya Medical Co., Ltd. (hereafter "Honya Medical"), a company specializing in the development of stem cell-based therapies, has developed an innovative new product — MiSaver — to overcome the limitations of conventional treatments.

Major Clinical Trial Results

In a Phase IIa clinical trial evaluating the safety and efficacy of MiSaver — a stem cell therapy using nucleated cells from umbilical cord blood — patients with acute myocardial infarction received the treatment via peripheral intravenous injection. The trial demonstrated significant improvement in left ventricular function. Conducted by Dr. Kwo-Chang Ueng and his team at Chung Shan Medical University Hospital, the study used an open-label, dose-escalation design. The treatment group included 10 male patients (average age: 56.5), while the control group included 20 patients. Follow-up lasted up to 12 months.

The results were encouraging: no unexpected adverse events were reported in the MiSaver group during the 12-month follow-up, and no signs of graft rejection were observed, confirming the high safety profile of cord blood stem cell therapy.

In terms of efficacy, patients treated with MiSaver showed a marked improvement in left ventricular ejection fraction (LVEF) — a key indicator of heart function — increasing from an average of 41.7% before treatment to 53.4% at 12 months. This outcome brings new hope for restoring cardiac function after a heart attack.

Innovative Mechanism and Therapeutic Advantages

MiSaver’s therapeutic mechanism harnesses the unique biological properties of stem cells—including their high proliferative and differentiation potential, low immunogenicity, and strong regenerative capacity. These characteristics contribute to promoting myocardial microvascular proliferation, enhancing blood perfusion, and supporting the restoration of cardiac function.

Unlike autologous therapies, MiSaver eliminates the need for harvesting cells from the patient, allowing for administration within the critical 2–5 day window following myocardial infarction. This streamlined approach improves timeliness, enhances clinical convenience, and may significantly increase the overall effectiveness of treatment

Key Insights and Future Outlook

The research team observed a potential link between obesity and treatment efficacy. Notably, the only patient who showed suboptimal improvement was also the youngest in the group and had morbid obesity. This observation suggests that lifestyle-related factors may influence recovery, highlighting the need to consider such variables in future trial designs and patient selection—offering valuable insights for precision medicine.

Honya Medical stated:

“This study not only confirms the safety and preliminary efficacy of MiSaver in treating acute myocardial infarction, but also paves the way for a new approach to cardiovascular disease management. The low immunogenicity and exceptional regenerative potential of MiSaver stem cells make them an ideal candidate for cardiac regenerative medicine.”

Encouraged by these results, the company is now preparing for a larger phase IIb/III clinical trial to further validate MiSaver’s therapeutic effectiveness. Approvals have already been secured from three leading academic medical centers for the next phase of clinical testing.

Industry Significance and Societal Impact

The results of this retrospective phase IIa clinical trial were published in the international journal Journal of Health Care Communications, drawing attention from the global academic community. With large-scale trials on the horizon, MiSaver is poised to become a major advancement in the treatment of myocardial infarction, offering new hope to cardiovascular patients worldwide. This not only provides an innovative treatment option but also underscores Taiwan’s competitive edge in the global biotech industry.

About Honya Medical Co., Ltd.

Honya Medical is a Taiwan-based stem cell pharmaceutical company dedicated to developing and commercializing innovative cell therapy products. The company focuses on translating advanced stem cell technologies into clinically meaningful therapies. Honya operates under international GMP standards for product development and manufacturing, with a strong emphasis on cell-based solutions for cardiovascular diseases.