Cell therapy and left ventricular restoration for ischemic cardiomyopathy: long-term results of a perspective, randomized study.

INTRODUCTION: Aim of this study is to verify the potential advantages and benefits of bone-marrow derived autologous stem cells implantation associated to surgical left ventricular restoration(SVR),to report a new modality of cell delivery to myocardium ,and to identify possible side effects of this procedure.

METHODS: Between March,2007 and March,2013,30 patients affected by ischemic dilative cardiomyopathy who received a SVR operation were enrolled in the study.The population was divided in two groups:16 patients were randomly assigned to receive Stem Cells Therapy in addition to SVR(groupA),14 patients received a placebo(group B).The two groups were homogeneous in respect of age, gender, pre-operative NYHA class, mitral incompetence and left ventricular sizes and volumes.The patients were evaluated by Echo and Pet- Scan before surgery and at 6 months follow-up, and by Echo at subsequent follow-up.

RESULTS: Overall 30 days-in hospital mortality was 0 for the entire cohort.At last follow-up ejection fraction increased from 25,3% before surgery to 36,3% in group A,and from 31,8% to 45,6% in group B.Reduction of LVEDD was 6% in group A,9% in group B.ESLVV and EDLVD decreased more significantly in patients receiving stem cells(55% vs.35%).Late cardiac mortality at 9 years follow-up was similar in the two groups of patients.No early or late adverse reaction nor cases of infections were observed.

CONCLUSIONS: Patients affected by ischemic cardiomyopathy have a favourable outcome after SVR.A higher reduction of LVEDV and LVESV assessed by CT-Scan evaluation in patients receiving cell therapy, when compared to control group, encourages the evolution and refinement of myocardial regenerative therapy added to SVR.