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document
Combined delivery approach of bone marrow mononuclear stem cells early and late after myocardial infarction : the MYSTAR prospective , randomized study . BACKGROUND Combined intracoronary and intramyocardial administration might improve outcomes for bone-marrow-derived stem cell therapy for acute myocardial infarction ( AMI ) . We compared the safety and feasibility of early and late delivery of stem cells with combined therapy approaches . METHODS Patients with left ventricular ejection fraction less than 45 % after AMI were randomly assigned stem cell delivery via intramyocardial injection and intracoronary infusion 3-6 weeks or 3-4 months after AMI . Primary end points were changes in infarct size and left ventricular ejection fraction 3 months after therapy . RESULTS A total of 60 patients were treated . The mean changes in infarct size at 3 months were -3.5 +/- 5.1 % ( 95 % CI -5.5 % to -1.5 % , P = 0.001 ) in the early group and -3.9 +/- 5.6 % ( 95 % CI -6.1 % to -1.6 % , P = 0.002 ) in the late group , and changes in ejection fraction were 3.5 +/- 5.6 % ( 95 % CI 1.3-5.6 % , P = 0.003 ) and 3.4 +/- 7.0 % ( 95 % CI 0.7-6.1 % , P = 0.017 ) , respectively . At 9-12 months after AMI , ejection fraction remained significantly higher than at baseline in both groups . In the early and late groups , a mean of 200.3 +/- 68.7 x 10 ( 6 ) and 194.8 +/- 60.4 x 10 ( 6 ) stem cells , respectively , were delivered to the myocardium , and 1.30 +/- 0.68 x 10 ( 9 ) and 1.29 +/- 0.41 x 10 ( 9 ) cells , respectively , were delivered into the artery . A high number of cells was required for significant improvements in the primary end points . CONCLUSIONS Combined cardiac stem cell delivery induces a moderate but significant improvement in myocardial infarct size and left ventricular function .
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Intervention_Physical
Combined delivery approach
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Intervention_Physical
bone marrow mononuclear stem cells early
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Intervention_Physical
bone-marrow-derived stem cell therapy
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Intervention_Physical
stem cells
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Intervention_Surgical
stem cell delivery
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Intervention_Surgical
intramyocardial injection
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Intervention_Surgical
intracoronary infusion 3-6 weeks or 3-4 months after AMI
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Intervention_Surgical
cardiac stem cell delivery
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Outcome_Other
safety and feasibility
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Outcome_Physical
changes in infarct size
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Outcome_Other
and
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Outcome_Physical
left ventricular ejection fraction 3 months after therapy
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Outcome_Physical
mean changes in infarct size at 3 months
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Outcome_Physical
changes in ejection fraction
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Outcome_Physical
ejection fraction
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Outcome_Physical
stem cells
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Outcome_Physical
number of cells
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Outcome_Physical
myocardial infarct size
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Outcome_Other
and
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Outcome_Physical
left ventricular function
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Participant_Condition
myocardial infarction
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Participant_Condition
left ventricular ejection fraction less than 45 % after AMI
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Participant_Sample-size
60