Effect of once versus twice injection of stem cell for patients with myocardial infarctio

Phase 2

Recruiting

• Conditions: Acute myocardial infarction.; Acute myocardial infarction, unspecified; 121.9

• Registration Number: IRCT20201116049408N1
• Lead Sponsor: Shiraz University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 30 November 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

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 )

Exclusion Criteria

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

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Ejection Fraction. Timepoint: within 6 months of intervention. Method of measurement: echocardiography.

Secondary Outcome Measures

Name	Time	Method
Hematologic variables, cardiac imaging (MRI), electrocardiogram. Timepoint: 2 weeks , 3 months , and 6 months after intervention. Method of measurement: lab kit for hematologic variables.