Status:
COMPLETED
MiSaver® Stem Cell Treatment for Heart Attack (Acute Myocardial Infarction)
Lead Sponsor:
Honya Medical Inc
Collaborating Sponsors:
Chung Shan Medical University
Conditions:
Myocardial Infarction
Eligibility:
All Genders
20-80 years
Phase:
PHASE1
PHASE2
Brief Summary
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)
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 26 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 4 2023
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT04050163
Start Date
January 26 2021
End Date
May 4 2023
Last Update
March 29 2024
Active Locations (2)
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1
Chung Shan Medical University Hospital
Taichung, Taichung City, Taiwan, 402
2
HONYA Medical Inc
Tainan, Taiwan, 74147