Meta-analysis of cell therapy trials for patients with heart failure
Sheila A Fisher1, Carolyn Doree1, Anthony Mathur1
1From the Systematic Review Group, R&D Department, NHS Blood and Transplant, Oxford, UK (S.A.F., C.D.); Nuffield Division of Clinical Laboratory Sciences, Radcliffe Department of Medicine, University of Oxford, Oxford, UK (S.A.F., C.D., E.M.-R.); Department of Clinical Pharmacology, William Harvey Research Institute, Queen Mary University of London, London, UK (A.M.); and Stem Cell Research Laboratory, R&D Department, NHS Blood and Transplant, Oxford, UK (E.M.-R.).
Insights
Autologous cell therapy shows promise for heart failure (HF) patients, reducing mortality and hospitalizations. While improving quality of life and heart function, further research is needed to confirm these benefits.
Area of Science:
- Regenerative Medicine
- Cardiology
- Clinical Trials
Background:
- Cell-based therapies offer a potential treatment for heart failure (HF) stemming from cardiomyopathy.
- The clinical effectiveness of these novel therapies warrants thorough investigation.
Purpose of the Study:
- To evaluate the existing clinical evidence regarding the safety and efficacy of cell-based therapies for heart failure.
- To synthesize findings from randomized controlled trials (RCTs) on cell therapy for HF.
Main Methods:
- A systematic review of RCTs was conducted using multiple electronic databases up to June 2014.
- Included trials compared autologous cell administration to no intervention or placebo in HF patients.
- Primary outcomes were mortality and HF-related rehospitalization; secondary outcomes included functional status, quality of life, and cardiac function.
Main Results:
- Thirty-one trials involving 1521 participants demonstrated that cell therapy significantly reduced mortality and rehospitalization in HF patients.
- Improvements were observed in performance status, exercise capacity, left ventricular ejection fraction, and quality of life.
- The therapy was associated with reduced brain natriuretic peptide levels and no increased incidence of arrhythmias, though trial bias was noted.
Conclusions:
- Autologous cell therapy presents potential benefits for patients with heart failure.
- Further robust clinical evidence is necessary to solidify the role of cell therapy in HF management.
Rationale:
Cell-based therapies are a promising intervention for the treatment of heart failure (HF) secondary to ischemic and nonischemic cardiomyopathy. However, the clinical efficacy of such new treatment requires further evaluation.
Objective:
To assess available clinical evidence on the safety and efficacy of cell-based therapies for HF.
Methods And Results:
Electronic databases (CENTRAL, DARE, NHSEED & HTA, PubMed, MEDLINE, EMBASE, CINAHL, LILACS, KoreaMed, PakMediNet, IndMed, and the Transfusion Evidence Library) were searched for relevant randomized controlled trials to June 2014. Trials of participants with HF and where the administration of any dose of autologous cells by any delivery route was compared with no intervention or placebo were eligible for inclusion. Primary outcomes were defined as mortality and rehospitalization as a result of HF. Secondary outcomes included performance status, quality of life, incidence of arrhythmias, brain natriuretic peptide levels, left ventricular ejection fraction, myocardial perfusion, and adverse events. Thirty-one independent trials (1521 participants) were included. The treatment significantly reduced the risk of mortality and rehospitalization caused by HF. There was a significant improvement in favor of stem cell treatment in performance status and exercise capacity, left ventricular ejection fraction, and quality of life. The treatment was also associated with a reduction of brain natriuretic peptide levels and no increase in the incidence of arrhythmias. However, there was considerable risk of performance, selection, and reporting bias among the included trials.
Conclusions:
This study shows evidence that autologous cell therapy may be beneficial for patients having HF, but further evidence is required.
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