Ignite Creation Date:
2024-05-06 @ 8:22 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06353958
Status:
COMPLETED
Last Update Posted:
2024-04-09
First Post:
2024-03-27
Brief Title:
MiSaver Stem Cell Treatment for Acute Myocardial Infarction
Sponsor:
Honya Medical Inc
Organization:
Honya Medical Inc
Study Overview
Official Title:
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
Status:
COMPLETED
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MiSaver
Brief 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
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
Detailed Description:
Cardiovascular diseases particularly acute myocardial infarction AMI persist as significant health concerns despite advancements in pharmaceutical and interventional treatments Hereininvestigators hypothesized stem cells could enhance left ventricular functional outcomes in patients recently afflicted by acute myocardial infarction AMI To investigate this hypothesis investigators initiated an open-label dose-escalating trial to evaluate the safety and feasibility of intravenous infusion of ABO matched allogeneic umbilical cord blood stem cells USC prefabricated into our study product MiSaver Myocardial Infarction Functional Saver in patients following recent AMI Participants were enrolled in cohorts of five each receiving low or middle dosages 05x107 and 16x107 cellskg respectively with infusions administered 2-5 days post-AMI onset
Study details for low and middle dose please see study NCT04050163
Retrospective participants meeting similar inclusion criteria of recent AMI and LVEF 45 were identified from the study site Twenty eligible participants were selected as controls and compared for analysis with the low and middle dosage groups
Study details for low and middle dose please see study NCT04050163
Retrospective participants meeting similar inclusion criteria of recent AMI and LVEF 45 were identified from the study site Twenty eligible participants were selected as controls and compared for analysis with the low and middle dosage groups
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None