IRCT201612201031N20
Completed
Phase 2
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
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Royan Institute
- Enrollment
- 90
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Not specified
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