MiSaver® Stem Cell Treatment for Acute Myocardial Infarction

Honya Medical

Status

Completed

Conditions

Acute Myocardial Infarction

Treatments

Drug: MiSaver

Study type

Observational

Funder types

Other

Industry

Identifiers

NCT06353958

MiSaver PIIa

Details and patient eligibility

About

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.

Full description

Cardiovascular diseases, particularly acute myocardial infarction (AMI), persist as significant health concerns despite advancements in pharmaceutical and interventional treatments. Herein,investigators 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 (0.5x10^7 and 1.6x10^7 cells/kg, 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.

Enrollment

30 patients

Sex

All

Ages

41 to 85 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patients aged between 20 and 80 years
Diagnosed with AMI within 7 days
Elevated cardiac enzymes (Creatine Kinase-MB or troponin) greater than 2 times the upper limit of normal
Presence of regional wall motion abnormality
LVEF ≤ 45% on echocardiography
Hemodynamically stable
Not requiring inotropic support
Systolic blood pressure below 80mm Hg for less than 1 hour
Resting heart rate above 100 beats/min for less than 1 hour in the past 24 hours
Peripheral artery oxygen saturation of ≥97%

Exclusion criteria

Pregnancy or breastfeeding
Positive adventitious infections (such as HIV, hepatitis)
Need for coronary artery bypass surgery or anticipated further revascularization procedures during the 6-month study period
Severe aortic or mitral valve narrowing
Evidence of life-threatening arrhythmia on baseline electrocardiogram (ECG)
Inability to receive PCI examination or treatment (including New York Heart Association (NYHA) Fc.IV) due to shortness of breath
Malignant tumor
Hematopoietic dysplasia
Other severe organ disease
Less than 1 year of life expectancy
Chronic kidney disease with estimated Glomerular Filtration Rate (eGFR)<20 and/or on renal dialysis