MiSaver® Stem Cell Treatment for Acute Myocardial Infarction - Trial NCT06353958
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.
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Study Focus
Sponsor & Location
Honya Medical Inc
Timeline & Enrollment
N/A
Jan 01, 2023
Dec 31, 2023
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
Data Source
ClinicalTrials.gov
NCT06353958
Non-Device Trial