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IRCT20201116049408N1 IRCT 2020-11-20 Shiraz University of Medical Sciences Effect of once versus twice injection of stem cell for patients with myocardial infarction Comparing the effects of once versus twice intracoronary injection of allogenic Wharton's jelly derived mesenchymal stem cell in improving ejection fraction of patients with post myocardial infarction moderate to severe reduced ejection fraction 2020-08-22 anticipated 60 Complete https://irct.ir/trial/52357 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization was done based on permuted balanced block method. Patients after inclusion and giving informed consent, were allocated to blocks of 6 using table of random numbers. Allocation concealment was adequate (the person who executed the allocation sequence was different from the person who recruited participants and had no direct contact with patients), Blinding description: The person doing the echocardiography and MRI exams is unaware of the groupings. 2-3 Acute myocardial infarction. Intervention 1: Intervention group: once injection of adipose tissue stem cells. Intervention 2: Intervention group: twice injection of adipose tissue stem cells. Intervention 3: Control group: received standard care ( for example PCI) for cardiac infarction with no further intervention. Yes - There is a plan to make this available What will be shared: all collected deidentified data When: available within 1 month after publication To whom: All researchers affiliated with academic settings. Conditions: no restriction applied. Where to obtain: Email contact with corresponding author: attar_armin@yahoo.com How to obtain: Email contact with corresponding author Comments:
public Ahmad monabati
zand avenue
Shiraz Iran (Islamic Republic of) 34786-71946 +98 71 3612 8258 monabatia@sums.ac.ir Shiraz University of Medical Sciences scientific Ahmad monabati
zand avenue
Shiraz Iran (Islamic Republic of) 34786-71946 +98 71 3612 8258 monabatia@sums.ac.ir Shiraz University of Medical Sciences Iran (Islamic Republic of) Ages20- 60 Years Genders: Both First MI within 3 to 5 days Post AMI LVEF less than 40% as assessed by echocardiography Negative pregnancy test ( in women with childbearing potential ) 20 years 60 years Both History of prior anterior myocardial infarction Patients with regional wall motion abnormalities in the non-infarct region prior CABG Patients with significant valve disease; defined as stenosis or regurgitation graded as greater than moderate (2+) Patients with another etiology of LV dysfunction (known/suspected non ischemic cardiomyopathy, previous anthracycline therapy, known ethanol abuse (greater than 6 oz. ethanol/day on a regular basis). Poor echocardiography window Active infection or history of recurrent infection or positive test for syphilis (RPR), hepatitis B and C (HBsAg, Anti-HCV), HIV and HTLV-1 Documental Terminal illness or malignancy Previous bone marrow transplant Autoimmune diseases 121.9 Acute myocardial infarction, unspecified Treatment - Other Treatment - Other Placebo Intervention group: once injection of adipose tissue stem cells Intervention group: twice injection of adipose tissue stem cells Control group: received standard care ( for example PCI) for cardiac infarction with no further intervention. Ejection Fraction. Timepoint: within 6 months of intervention. Method of measurement: echocardiography. Hematologic variables, cardiac imaging (MRI), electrocardiogram. Timepoint: 2 weeks , 3 months , and 6 months after intervention. Method of measurement: lab kit for hematologic variables. Shiraz University of Medical Sciences Approved 2020-06-20 Ethics committee of Shiraz university of Medical Sciences Zand avenue shiraz Fars Iran (Islamic Republic of)