Comparing the effects of once versus twice intracoronary injection of allogenic adipose tissue derived mesenchymal stem cell in improving ejection fraction of patients with post myocardial infarction moderate to severe reduced ejection fraction
Comparing the effects of once versus twice intracoronary injection of allogenic adipose tissue derived mesenchymal stem cell in improving ejection fraction of patients with post myocardial infarction moderate to severe reduced ejection fraction
Design
Three arm parallel group randomized trial with blinded outcome assessment
Settings and conduct
Hospital setting equipped with cardiology units. Outcome assessment (the interpretation of echocardiographic findings) will be done by a physician blinded to group allocation.
Participants/Inclusion and exclusion criteria
Inclusion:
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
History of prior anterior myocardial infarction
Patients with regional wall motion abnormalities in the non-infarct region
prior CABG
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 disease (e.g.Lupus, Multiple Sclerosis)
Intervention groups
1) 20 patients will receive 1 injection of allogenic mesenchymal cells derived from fat tissue.
2) 20 patients will receive 2 injections of allogenic mesenchymal stem cells derived from fat tissue with 1 month interval.
3) control group will receive standard treatment of PCI.
Main outcome variables
effects of stem cell injection(once vs twice) on echocardiographic findings.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201116049408N1
Registration date:2020-11-20, 1399/08/30
Registration timing:registered_while_recruiting
Last update:2020-11-20, 1399/08/30
Update count:1
Registration date
2020-11-20, 1399/08/30
Registrant information
Name
Armin Attar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3628 3353
Email address
attar_armin@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-08-22, 1399/06/01
Expected recruitment end date
2021-01-20, 1399/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effects of once versus twice intracoronary injection of allogenic adipose tissue derived mesenchymal stem cell in improving ejection fraction of patients with post myocardial infarction moderate to severe reduced ejection fraction
Public title
Effect of once versus twice injection of stem cell for patients with myocardial infarction
Purpose
Treatment
Inclusion/Exclusion 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:
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
Age
From 20 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
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 (investigator's opinion)
Single blinded
Blinding description
Outcome measure of this study (like echo findings) would be recorded and evaluated by an investigator who is blinded to allocation of study groups.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shiraz university of Medical Sciences
Street address
Zand avenue
City
shiraz
Province
Fars
Postal code
34786-71946
Approval date
2020-06-20, 1399/03/31
Ethics committee reference number
IR.SUMS.REC.1399.406
Health conditions studied
1
Description of health condition studied
Acute myocardial infarction
ICD-10 code
121.9
ICD-10 code description
Acute myocardial infarction, unspecified
Primary outcomes
1
Description
comparison of once versus twice injection of stem cells from adipose tissue on echo findings from patients with AMI