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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

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20201116049408N1
Enrollment
60
Registered
2020-11-20
Start date
2020-08-22
Completion date
Unknown
Last updated
2020-11-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute myocardial infarction. Acute myocardial infarction, unspecified

Interventions

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: recei

Sponsors

Shiraz University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
20 Years to 60 Years

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
Ejection Fraction. Timepoint: within 6 months of intervention. Method of measurement: echocardiography.

Secondary

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

Countries

Iran (Islamic Republic of)

Contacts

Public ContactAhmad monabati

Shiraz University of Medical Sciences

monabatia@sums.ac.ir+98 71 3612 8258

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 18, 2026