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MiSaver® Stem Cell Treatment for Acute Myocardial Infarction

NCT06353958 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 30

Last updated 2024-10-04

No results posted yet for this study

Summary

Despite advancements in treatments, cardiovascular diseases, especially acute myocardial infarction (AMI), remain significant health concerns. This study hypothesized that stem cells could improve left ventricular function post-AMI. An open-label trial was initiated to assess the safety and feasibility of intravenous infusion of ABO blood group-matched allogeneic umbilical cord blood stem cells (USC) prefabricated into MiSaver (Myocardial Infarction Saver) in AMI patients.

Primary Endpoint:

The primary endpoint focused on safety and adverse events over a 12-month observational period. Results showed the treatment was well-tolerated with no AEs attributed to the study product.

Secondary Outcomes:

Secondary outcomes evaluated changes in left ventricular ejection fraction (LVEF) from baseline to 12 months post-treatment. A retrospective study compared eligible controls with low and middle dosage groups.

Conditions

  • Acute Myocardial Infarction

Interventions

DRUG

MiSaver

MiSaver vials was thawed using a thermostat-controlled mini bath, drawn into a 20ml syringe, and diluted with normal saline and intravenous infused following standard operating procedures, consecutively, until reasching the dosage. Patients were premedicated with intravenous antihistamines (such as diphenhydramine) and corticosteroids (such as hydrocortisone) 30-60 minutes before the stem cell infusion. Any unused solution was discarded, and the total volume of injected solution was adjusted to accommodate the total daily fluid volume administered.

Sponsors & Collaborators

  • Chung Shan Medical University

    collaborator OTHER

  • Honya Medical Inc

    lead INDUSTRY

Eligibility

Min Age
41 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-01
Primary Completion
2023-12-31
Completion
2023-12-31

Countries

  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06353958 on ClinicalTrials.gov