MiSaver® Stem Cell Treatment for Heart Attack (Acute Myocardial Infarction)
NCT ID: NCT04050163
Last Updated: 2024-03-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
11 participants
INTERVENTIONAL
2021-01-26
2023-05-04
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
SINGLE
Study Groups
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Low Dose
Cells dosage, 0.5x10\^7 cells/kg body weight
MiSaver®
Intravenous administration of MiSaver® Stem Cell via peripheral vein access.
Intermediate Dose (aka Effective or High)
Cells dosage, 1.6x10\^7 cells/kg body weight
MiSaver®
Intravenous administration of MiSaver® Stem Cell via peripheral vein access.
Toxic Dose
Cells dosage, 5.0 x10\^7 cells/kg body weight
MiSaver®
Intravenous administration of MiSaver® Stem Cell via peripheral vein access.
Interventions
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MiSaver®
Intravenous administration of MiSaver® Stem Cell via peripheral vein access.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
20 Years
80 Years
ALL
No
Sponsors
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Chung Shan Medical University
OTHER
Honya Medical Inc
INDUSTRY
Responsible Party
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Locations
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Chung Shan Medical University Hospital
Taichung, Taichung City, Taiwan
HONYA Medical Inc
Tainan City, , Taiwan
Countries
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Other Identifiers
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csho19052112001
Identifier Type: -
Identifier Source: org_study_id
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