MiSaver® Stem Cell Treatment for Heart Attack (Acute Myocardial Infarction)

Honya Medical

Status and phase: Completed; Phase 2; Phase 1

Conditions: Myocardial Infarction

Treatments: Biological: MiSaver®

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04050163

csho19052112001

Details and patient eligibility

About

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)

Enrollment: 11 patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: Single Blind

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11 participants in 3 patient groups

Low Dose

Experimental group

Description:

Cells dosage, 0.5x10\^7 cells/kg body weight

Treatment:

Biological: MiSaver®

Intermediate Dose (aka Effective or High)

Experimental group

Description:

Cells dosage, 1.6x10\^7 cells/kg body weight

Treatment:

Biological: MiSaver®

Toxic Dose

Experimental group

Description:

Cells dosage, 5.0 x10\^7 cells/kg body weight

Treatment:

Biological: MiSaver®