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
Objectives: improvement of left ventricular function in STEMI patients after intramyocardial injections of 2 types of autologous bone marrow derived cells into the infarcted myocardium compared to a placebo group during CABG.
Design: A Phase II/III, Multicenter, Placebo-Controlled, Randomized, Double-Blind Clinical Trial
Methods: 90 patients with first anterior STEMI (10 days - 3 months), 18-75 years, both gender and CABG candidate selected for randomization in 3 groups [CD133+, the MNC (MonoNuclear Cell), and placebo] and intramyocardial injection during CABG. They underwent real or sham aspiration. They followed at 6 and 18 months after surgery by SPECT and clinical assessments.
The primary endpoint was assessed by changes in global left ventricular ejection fraction (LVEF) at rest by gated SPECT.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201612201031N20
Registration date:2017-01-14, 1395/10/25
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-01-14, 1395/10/25
Registrant information
Name
Nasser Aghdami
Name of organization / entity
Royan Institute
Country
Iran (Islamic Republic of)
Phone
+98 21 2356 2000
Email address
nasser.aghdami@royaninstitute.org
Recruitment status
Recruitment complete
Funding source
Department of Regenerative Biomedicine, Cell Science Research Center, Royan Institute for Stem Cell Biology and Technology
Expected recruitment start date
2007-12-31, 1386/10/10
Expected recruitment end date
2012-06-30, 1391/04/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
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
Public title
Intramyocardial injection of transplantation of autologous bone marrow derived MNC (MonoNuclear Cell) and CD133+ cells comparison to placebo, on LVEF in MI patients
Purpose
Treatment
Inclusion/Exclusion 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
Age
From 18 years old to 75 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Computer-generated randomization sequence in a 1:1:1 ratio between the CD133+, the MNC, and placebo groups
Secondary Ids
1
Registry name
ClinicalTrials.gov
Secondary trial Id
NCT01167751
Registration date
2010-07-19, 1389/04/28
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Royan infertility institute
Street address
Royan institute, Eastern Hafez St,Northern Banihashem St, 45 m Resalat highway
City
Tehran
Postal code
Approval date
2006-10-04, 1385/07/12
Ethics committee reference number
پ-85-106
Health conditions studied
1
Description of health condition studied
Acute transmural myocardial infarction of anterior wall