Protocol summary
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Study aim
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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
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Design
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Three arm parallel group randomized trial with blinded outcome assessment
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Settings and conduct
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Hospital setting equipped with cardiology units. Outcome assessment (the interpretation of echocardiographic findings) will be done by a physician blinded to group allocation.
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Participants/Inclusion and exclusion criteria
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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)
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Intervention groups
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1) 20 patients will receive 1 injection of allogenic mesenchymal cells derived from Wharton's Jelly.
2) 20 patients will receive 2 injections of allogenic mesenchymal stem cells derived from Wharton's Jelly with 1 month interval.
3) control group will receive standard treatment of PCI.
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Main outcome variables
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effects of stem cell injection(once vs twice) on echocardiographic findings.
General information
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Reason for update
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Since preclinical studies have shown that Wharton's jelly derived mesenchymal stem cells are most effective when transplanted to heart, it was decided to change the source of the cells to this tissue.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20201116049408N1
Registration date:
2020-11-20, 1399/08/30
Registration timing:
registered_while_recruiting
Last update:
2020-11-26, 1399/09/06
Update count:
1
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Registration date
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2020-11-20, 1399/08/30
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2020-08-22, 1399/06/01
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Expected recruitment end date
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2022-01-21, 1400/11/01
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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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
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Public title
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Effect of once versus twice injection of stem cell for patients with myocardial infarction
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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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
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Age
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From 20 years old to 60 years old
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Gender
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Both
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Phase
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2-3
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Groups that have been masked
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- Outcome assessor
- Data analyser
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Sample size
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Target sample size:
60
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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)
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Blinding (investigator's opinion)
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Single blinded
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Blinding description
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The person doing the echocardiography and MRI exams is unaware of the groupings.
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2020-06-20, 1399/03/31
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Ethics committee reference number
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IR.SUMS.REC.1399.406
Health conditions studied
1
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Description of health condition studied
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Acute myocardial infarction
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ICD-10 code
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121.9
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ICD-10 code description
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Acute myocardial infarction, unspecified
Primary outcomes
1
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Description
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Ejection Fraction
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Timepoint
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within 6 months of intervention
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Method of measurement
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echocardiography
Secondary outcomes
1
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Description
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hematologic variables, cardiac imaging (MRI), electrocardiogram
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Timepoint
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2 weeks , 3 months , and 6 months after intervention
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Method of measurement
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lab kit for hematologic variables
Intervention groups
1
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Description
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Intervention group: once injection of adipose tissue stem cells
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Category
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Treatment - Other
2
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Description
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Intervention group: twice injection of adipose tissue stem cells
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Category
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Treatment - Other
3
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Description
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Control group: received standard care ( for example PCI) for cardiac infarction with no further intervention.
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Category
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Placebo
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Shiraz University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available
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Title and more details about the data/document
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all collected deidentified data
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When the data will become available and for how long
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available within 1 month after publication
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To whom data/document is available
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All researchers affiliated with academic settings.
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Under which criteria data/document could be used
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no restriction applied.
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From where data/document is obtainable
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Email contact with corresponding author: attar_armin@yahoo.com
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What processes are involved for a request to access data/document
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Email contact with corresponding author
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Comments
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