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NCT06353958Completed

MiSaver® Stem Cell Treatment for Acute Myocardial Infarction

A Retrospective Phase IIa Study of Intravenous Allogeneic Non-HLA-Matched, Unrelated Donor Stem Cell, MiSaver (Myocardial Infarction Saver), Infusion for Recent Acute Myocardial Infarction
Honya Medical IncClinicalTrials.govdrug
Verified
Study focus
Disease/Condition
Acute Myocardial Infarction
Drug/Device/Intervention
MiSaver
Study type
Observational
Intervention type
drug
Sponsor & location
Primary sponsor
Honya Medical Inc
Location
Taichung, Taiwan
Timeline & enrollment
Phase
N/A
Start date
Jan 01, 2023
End date
Dec 31, 2023
Enrollment
30 participants
Primary outcome

Safety and adverse events events

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.

ICD-10 classifications
Acute myocardial infarctionAcute myocardial infarction, unspecifiedAcute subendocardial myocardial infarctionCertain current complications following acute myocardial infarctionOther current complications following acute myocardial infarction
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06353958
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT06353958 through Pure Global AI's free database. This phase not specified trial is sponsored by Honya Medical Inc and is currently Completed. The study focuses on Acute Myocardial Infarction. Target enrollment is 30 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.