Efficacy and Safety of Stem Cell Therapy in Advanced Heart Failure Patients: A Systematic Review with a Meta-analysis of Recent Trials Between 2017 and 2019.

Joseph S Jayaraj,Tooba Kashif,Aisha Qaseem,Sanjiv Bakshi,Vineeth K Reddy,Nida Fathima,Rajesh N Janapala,Norina Usman

doi:10.7759/cureus.5585

Abstract

ObjectiveThe effects of stem cell therapy in patients with advanced heart failure is an ongoing debate. This study aimed to assess the effectiveness and safety of stem cell therapy plus the standard of care as compared to the placebo plus the standard of care in advanced heart failure patients.MethodsA comprehensive keyword search of PubMed between 2017 and 2019 was performed to extract trials conducted with stem cell therapy controlled with placebo in advanced heart failure. We included randomized controlled trials (RCTs) with data on safety and efficacy in patients with advanced heart failure after stem cell transplantation.ResultsSix RCTs, consisting of 569 patients, were selected. Three-hundred sixty-seven (367) out of 369 participants from the eligible four out of six RCTs were included for efficacy analysis, as we lost two patients from the final analysis due to early death. Five-hundred twenty-six (526) out of 527 participants from the eligible five out of six RCTs were included for safety analysis, as we lost one patient from the final analysis for not being able to receive the intervention. Stem cell transplantation significantly improved left ventricular ejection fraction (LVEF) by 4.58% (95% CI: 3.73-5.43%; p = 0.00001), improved left ventricular end-systolic volume (LVESV) by -5.18 ml (95% CI: -9.74 to -0.63 ml; p =0.03), and there was no difference in the risk of all-cause mortality (OR 0.97; 95% CI: 0.52 to 1.78%; p = 0.91). The above results correlate with the previous meta-analysis data conducted in 2016.ConclusionsThis meta-analysis provided the cumulative efficacy and safety results of stem cell transplantation in advanced heart failure based on recent RCTs. The above results suggest that stem cell therapy was associated with a moderate improvement in LVEF, and the safety analysis indicates no increased risk of mortality in patients with advanced heart failure. This meta-analysis recommends conducting more RCTs comparing stem cell transplantation and placebo with a larger patient population and longer follow-up.

Highlights

Clinical vignette "A 68- year old male presented to the hospital with chest pain in September 2008 and he underwent an Electrocardiogram (EKG) which showed a finding of ST-Elevation Myocardial Infarction (STEMI) and later the finding got confirmed by positive cardiac biomarkers, and diagnosed with Myocardial Infarction (MI)
Stem cell transplantation significantly improved left ventricular ejection fraction (LVEF) by 4.58%, improved left ventricular end-systolic volume (LVESV) by -5.18 ml, and there was no difference in the risk of all-cause mortality
The above results correlate with the previous metaanalysis data conducted in 2016. This meta-analysis provided the cumulative efficacy and safety results of stem cell transplantation in advanced heart failure based on recent randomized controlled trials (RCTs)

Summary

Introduction

Clinical vignette "A 68- year old male presented to the hospital with chest pain in September 2008 and he underwent an Electrocardiogram (EKG) which showed a finding of ST-Elevation Myocardial Infarction (STEMI) and later the finding got confirmed by positive cardiac biomarkers, and diagnosed with Myocardial Infarction (MI). Following which the patient was admitted and treated according to the standard of care available in the hospital. Cardiology/American Heart Association (ACC/AHA) guidelines, following thrombolysis, the patient developed complications of ventricular fibrillation, heart failure, and pulmonary infection. The patient underwent an alternate intervention with allogeneic umbilical Cord Blood Mononuclear Cells (CB-MNC's). The High N-Terminal Prohormone of Brain Natriuretic Peptide (NT-proBNP) levels after nine months of MI normalized after CB-MNC treatment; the Patients activity improved significantly after CB-MNC treatment, and during the follow-up period the patient was able to walk 400m in a 6 min walk test. After treatment with CB-MNC's, LVEF improvement and scar size reduction was noticed, but there was a negative correlation with results of 6 min walk test and NT-proBNP levels after six months of therapy" [1]

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Discussion

Conclusion