Trial | NCT04050163  Report issue

Title

MiSaver® Stem Cell Treatment for Heart Attack (Acute Myocardial Infarction)
Safety and Preliminary Efficacy Study of Intravenous Administration of MiSaver® (Myocardial Infarction Saver) After Acute Myocardial Infarction, a Phase I/IIa Clinical Trial.

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    11
The objective of the present study is to establish the safety and efficacy of MiSaver® Stem Cell Treatment After a Heart Attack (Acute Myocardial Infarction)
Study Started
Jan 26
2021
Primary Completion
May 04
2023
Study Completion
May 04
2023
Last Update
Oct 10
2023

Biological MiSaver®

Intravenous administration of MiSaver® Stem Cell via peripheral vein access.

  • Other names: stem cells

Low Dose Experimental

Cells dosage, 1/vial for every 20kg body weight.

Intermediate Dose Experimental

Cells dosage, 1/vial for every 10kg body weight.

Toxic Dose Experimental

Cells dosage, 2.5/vial for every 10kg body weight.

Criteria 

Inclusion Criteria:

Patients aged 20~80
Acute Myocardial Infarction 1 to 10 days
Cardiac enzyme CK-MB or Troponin > 2X of high-end normal value
ST-elevation on EKG (STEMI)
Presence of regional wall motion abnormality
Left ventricular ejection fraction (LVEF) of ≤40%
Hemodynamically stable past 24 hour
Participants with adequate pulmonary function
Peripheral artery oxygen saturation ≥97%
Karnofsky performance status scores of ≥60.

Exclusion Criteria:

Age <20 or >80
Pregnant or breast feeding
Positive adventitious infections (such as HIV, hepatitis )
Revascularization via coronary artery bypass surgery is required
Coronary revascularization procedures is anticipated during the 6-month study period
Severe aortic or mitral valve narrowing
Evidence of life-threatening arrhythmia on baseline electrocardiogram (ECG)
Short of breath unable to receive PCI examination or treatment
Malignant tumor
Hematopoietic dysplasia
Severe organ disease
With less than 1 year of life expectancy
Chronic kidney disease with CCr<20ml/min
Kidney disease on renal dialysis
No Results Posted