Intramyocardial injection of transplantation of autologous bone marrow derived MNC (MonoNuclear Cell) and CD133+ cells comparison to placebo, on LVEF in MI patients
- Conditions
- Acute transmural myocardial infarction of anterior wall.Transmural infarction (acute)(of): • anterior (wall) NOS • anteroapical • anterolateral • anteroseptal
- Registration Number
- IRCT201612201031N20
- Lead Sponsor
- Royan Institute
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 90
18-75 years; First ST elevation myocardial infarction (STEMI) 10 days - 3 months; Post-acute myocardial infarction (AMI) left ventricular ejection fraction (LVEF) as assessed by echocardiography: 20%-45%; Target lesion must be located in the left anterior descending (LAD) section; Coronary artery bypass graft (CABG) candidate; At least 4 akinetic segments (assessed by stress echocardiography).
Exclusion criteria:
History of prior AMI; Active infection; History of recurrent infection; Positive test for syphilis (RPR); Hepatitis B and C (HBsAg, anti-HBc, anti-HCV); HIV or HTLV-1; Documented terminal illness or malignancy; Documented autoimmune disease; Pulmonary edema; Urgent or emergency CABG; Systolic blood pressure <80 mmHg; 4000 > leukocytes (µL) >15000; AST >100 IU/L or ALT >100 IU/L; Hemoglobin <10 g/dL; Platelets <100,000/µL; INR >1.8
Not provided
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Changes in global left ventricular ejection fraction (LVEF) at rest between group. Timepoint: Base, 6 and 18 months after CABG. Method of measurement: SPECT.
- Secondary Outcome Measures
Name Time Method YHA classification. Timepoint: base and 18 month after CABG. Method of measurement: Standard classification of NYHA.;Perfusion defect score (PDS). Timepoint: Base, 6 and 18 months after CABG. Method of measurement: SPECT.;Non-viable (NV) segments. Timepoint: Base, 6 and 18 months after CABG. Method of measurement: SPECT.;Decrease systolic wall thickening (Dec. Thickening) of the myocardium. Timepoint: Base, 6 and 18 months after CABG. Method of measurement: SPECT.;Wall motion score (WMS). Timepoint: Base, 6 and 18 months after CABG. Method of measurement: SPECT.;Adverse events assessment (included death, reinfarction, implantable cardioverter defibrillator (ICD) placement, infection, and arrhythmia). Timepoint: Base, 6 and 18 months after CABG. Method of measurement: Physician assessment.