MedStar Authors catalog › Details for: Rationale and design of a randomized controlled trial of allogeneic mesenchymal stem cells in patients with nonischemic cardiomyopathy.
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Rationale and design of a randomized controlled trial of allogeneic mesenchymal stem cells in patients with nonischemic cardiomyopathy.

by Epstein, Stephen E.
Citation: Journal of Cardiovascular Medicine. 18(4):283-290, 2017 Apr.Journal: Journal of cardiovascular medicine (Hagerstown, Md.).Published: 2017ISSN: 1558-2027.Full author list: Greene SJ; Epstein SE; Kim RJ; Quyyumi AA; Cole RT; Anderson AS; Wilcox JE; Skopicki HA; Sikora S; Verkh L; Tankovich NI; Gheorghiade M; Butler J.UI/PMID: 26479144.Subject(s): Cardiomyopathies/dg [Diagnostic Imaging] | Cardiomyopathies/pp [Physiopathology] | *Cardiomyopathies/su [Surgery] | Clinical Protocols | Cross-Over Studies | Echocardiography | Heart Failure/dg [Diagnostic Imaging] | Heart Failure/pp [Physiopathology] | *Heart Failure/su [Surgery] | Humans | Magnetic Resonance Imaging, Cine | Mesenchymal Stem Cell Transplantation/ae [Adverse Effects] | *Mesenchymal Stem Cell Transplantation | Myocardium/pa [Pathology] | Pilot Projects | Recovery of Function | Research Design | Single-Blind Method | Stroke Volume | Time Factors | Treatment Outcome | United States | Ventricular Function, Left | Ventricular RemodelingInstitution(s): MedStar Health Research InstituteActivity type: Journal Article.Medline article type(s): Journal ArticleOnline resources: Click here to access online Digital Object Identifier: https://dx.doi.org/10.2459/JCM.0000000000000303 (Click here) Abbreviated citation: J Cardiovasc Med (Hagerstown). 18(4):283-290, 2017 Apr.Local Holdings: Available online through MWHC library: 2006 - present.Abstract: AIMS: This article describes an ongoing study investigating the safety and efficacy of ischemia-tolerant mesenchymal stem cell (MSC) therapy in patients with nonischemic heart failure and dysfunctional viable myocardium without scarring. This study will follow principles of the previously described mechanistic translational-phase concept whereby the effect of the study agent on laboratory and imaging markers of cardiac structure and function will be tested in a small homogenous cohort with the goal to enhance the understanding of the effect of interventions on cardiac remodeling and performance.Abstract: STUDY DESIGN: This single-blind, placebo-controlled, crossover, multicenter, randomized study will assess the safety, tolerability, and preliminary efficacy of a single intravenous (i.v.) dose of allogeneic ischemia-tolerant MSCs in individuals with heart failure of nonischemic cause, ejection fraction 40% or less, and dysfunctional viable myocardium who have been receiving guideline-directed medical therapy. Eligible patients will have no evidence of baseline replacement scarring on delayed-enhancement cardiac magnetic resonance (CMR). Approximately 20 patients will be randomized in a 1 : 1 ratio to receive an i.v. infusion of ischemia-tolerant MSCs or placebo. At 90 days, the two groups will undergo crossover and received the alternative treatment. The primary endpoint is safety, as evaluated through at least 1-year post-MSC infusion. Additional efficacy endpoints will include measures of cardiac structure and function, as evaluated by serial cine-CMR and transthoracic echocardiography at 90 and 180 days post-initial infusion.Abstract: CONCLUSION: This pilot study will explore the safety and effects on cardiac structure and function of i.v. injection of ischemia-tolerant MSCs in a small homogenous cohort of nonischemic heart failure patients with reduced ejection fraction and absent replacement scarring on CMR. This study also represents a prospective mechanistic translational-phase study using baseline and serial CMR imaging in heart failure patients and serves as a potential model for design of future heart failure trials (ClinicalTrials.gov identifier: NCT02467387).

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