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IRCT201612201031N20 IRCT 2017-01-14 Royan Institute Intramyocardial injection of transplantation of autologous bone marrow derived MNC (MonoNuclear Cell) and CD133+ cells comparison to placebo, on LVEF in MI patients The effect of intramyocardial transplantation of autologous bone marrow derived MNC (MonoNuclear Cell) and CD133+ cells comparison to placebo, on LVEF in MI patients, A Phase II/III, Multicenter, Placebo-Controlled, Randomized, Double-Blind Clinical Trial 2007-12-31 anticipated 90 Complete https://irct.ir/trial/44 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: Computer-generated randomization sequence in a 1:1:1 ratio between the CD133+, the MNC, and placebo groups. 2-3 Acute transmural myocardial infarction of anterior wall. Intervention 1: Intervention: Intramyocardial injection of 3 cc authologous bone marrow derived cell (MNC) using a 22-gauge needle. Intervention 2: Intervention: Intramyocardial injection of 3 cc authologous bone marrow derived cell (CD133) using a 22-gauge needle. Intervention 3: Intervention: Intramyocardial injection of 3 cc placebo using a 22-gauge needle.
public Hoda Madani
Eastern Hafez St, Northern Banihashem St, 45 m Resalat highway
Tehran Iran (Islamic Republic of) +98 21 2356 2458 hoda62_m@yahoo.com Royan Institute scientific Nasser Aghdami
Eastern Hafez St,Northern Banihashem St, 45 m Resalat highway
Tehran Iran (Islamic Republic of) +98 21 2356 2000 nasser.aghdami@royaninstitute.org Royan Institute Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Inclusion criteria: 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 18 years 75 years Both I21.0 Transmural infarction (acute)(of): • anterior (wall) NOS • anteroapical • anterolateral • anteroseptal Treatment - Other Treatment - Other Placebo Intervention: Intramyocardial injection of 3 cc authologous bone marrow derived cell (MNC) using a 22-gauge needle Intervention: Intramyocardial injection of 3 cc authologous bone marrow derived cell (CD133) using a 22-gauge needle Intervention: Intramyocardial injection of 3 cc placebo using a 22-gauge needle Changes in global left ventricular ejection fraction (LVEF) at rest between group. Timepoint: Base, 6 and 18 months after CABG. Method of measurement: SPECT. NYHA 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. NCT01167751 ClinicalTrials.gov Royan Institute Approved 2006-10-04 Ethics committee of Royan infertility institute Royan institute, Eastern Hafez St,Northern Banihashem St, 45 m Resalat highway Tehran Iran (Islamic Republic of)