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Safety and Efficacy of MiSaver (CB Cells) for Acute Myocardial Infarction, Phase II

NCT07134712 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 102

Last updated 2026-03-11

No results posted yet for this study

Summary

This trial is a Phase II, multicenter clinical study. The purpose of this trial is to evaluate the safety and efficacy of MiSaver, a cellular therapy product, in patients who have experienced an acute myocardial infarction (AMI). Specifically, the study aims to assess the improvement in left ventricular function of the heart following the administration of MiSaver, as well as to determine the safety of using stem cell therapy in these patients.

This trial will employ a single-blind design (subject-blinded), meaning that the participants will not be aware of whether they are receiving MiSaver or standard treatment, while the researchers will have this information. This design helps ensure transparency and adherence to ethical standards while also providing valuable clinical insights.

By utilizing randomization, we can enhance the reliability and comparability of the study results. A portion of the participants will receive MiSaver, while the others will undergo standard treatment. This allows for a direct comparison of the two therapeutic approaches to determine their respective efficacy.

The primary objective of this trial is to evaluate the safety and efficacy of MiSaver, in the treatment of patients with acute myocardial infarction (AMI). To achieve this, we will collect comprehensive participant data, including assessments of cardiac function, records of cardiac events, and quality-of-life surveys. By analyzing these data, we aim to gain a deeper understanding of the benefits and limitations of this treatment approach.

Conditions

  • Acute Myocardial Infarction (AMI)

Interventions

BIOLOGICAL

Cord Blood Nucleated cells

MiSaver will be administered via peripheral intravenous injection. Based on dosage, the experimental group will be divided into two subgroups: 0.5 × 10⁷ or 1.6 × 10⁷ nucleated cells per kilogram of patient body weight.

Sponsors & Collaborators

  • HONYA Medical Co Ltd

    lead INDUSTRY

Principal Investigators

  • Kwo-Chang Ueng, PhD · Chung Shan Medical University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
45 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-30
Primary Completion
2027-12-31
Completion
2027-12-31

Countries

  • Australia
  • 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 NCT07134712 on ClinicalTrials.gov