Intravenous Allogeneic Mesenchymal Stem Cells for Nonischemic Cardiomyopathy: Safety and Efficacy Results of a Phase II-A Randomized Trial. (Record no. 2234)

MARC details
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fixed length control field 04131nam a22005777a 4500
008 - FIXED-LENGTH DATA ELEMENTS--GENERAL INFORMATION
fixed length control field 170428s20172017 xxu||||| |||| 00| 0 eng d
022 ## - INTERNATIONAL STANDARD SERIAL NUMBER
International Standard Serial Number 0009-7330
040 ## - CATALOGING SOURCE
Original cataloging agency Ovid MEDLINE(R)
099 ## - LOCAL FREE-TEXT CALL NUMBER (OCLC)
PMID 27856497
245 ## - TITLE STATEMENT
Title Intravenous Allogeneic Mesenchymal Stem Cells for Nonischemic Cardiomyopathy: Safety and Efficacy Results of a Phase II-A Randomized Trial.
251 ## - Source
Source Circulation Research. 120(2):332-340, 2017 Jan 20
252 ## - Abbreviated Source
Abbreviated source Circ Res. 120(2):332-340, 2017 Jan 20
253 ## - Journal Name
Journal name Circulation research
260 ## - PUBLICATION, DISTRIBUTION, ETC.
Year 2017
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Manufacturer FY2017
260 ## - PUBLICATION, DISTRIBUTION, ETC.
Manufacturer FY2017
266 ## - Date added to catalog
Date added to catalog 2017-04-28
501 ## - WITH NOTE
Local holdings Available online from MWHC library: 1953 - present
520 ## - SUMMARY, ETC.
Abstract CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT02467387.
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Abstract CONCLUSIONS: In this pilot study of patients with nonischemic cardiomyopathy, itMSC therapy was safe, caused immunomodulatory effects, and was associated with improvements in health status and functional capacity.
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Abstract Copyright 2016 American Heart Association, Inc.
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Abstract METHODS AND RESULTS: This was a single-blind, placebo-controlled, crossover, randomized phase II-a trial of nonischemic cardiomyopathy patients with left ventricular ejection fraction <40% and absent hyperenhancement on cardiac magnetic resonance imaging. Patients were randomized to intravenously administered itMSCs (1.5x10<sup>6</sup> cells/kg) or placebo; at 90 days, each group received the alternative treatment. Overall, 22 patients were randomized to itMSC (n=10) and placebo (n=12) at baseline. After crossover, data were available for 22 itMSC patients. No major differences in death, hospitalization, or serious adverse events were noted between the 2 treatments. Change from baseline in left ventricular ejection fraction and ventricular volumes was not significantly different between therapies. Compared with placebo, itMSC therapy increased 6-minute walk distance (+36.47 m, 95% confidence interval 5.98-66.97; P=0.02) and improved Kansas City Cardiomyopathy clinical summary (+5.22, 95% confidence interval 0.70-9.74; P=0.02) and functional status scores (+5.65, 95% confidence interval -0.11 to 11.41; P=0.06). The data demonstrated MSC-induced immunomodulatory effects, the magnitude of which correlated with improvement in left ventricular ejection fraction.
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Abstract OBJECTIVE: To assess the safety and preliminary efficacy of intravenously administered ischemia-tolerant MSCs (itMSCs) in patients with nonischemic cardiomyopathy.
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Abstract RATIONALE: Potential benefits of mesenchymal stem cell (MSC) therapy in heart failure may be related to paracrine properties and systemic effects, including anti-inflammatory activities. If this hypothesis is valid, intravenous administration of MSCs should improve outcomes in heart failure, an entity in which excessive chronic inflammation may play a pivotal role.
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Language note English
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Topical term or geographic name entry element *Cardiomyopathies/di [Diagnosis]
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Topical term or geographic name entry element *Cardiomyopathies/th [Therapy]
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element *Health Status
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Topical term or geographic name entry element *Mesenchymal Stem Cell Transplantation/mt [Methods]
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element Adult
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element Cardiomyopathies/bl [Blood]
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Topical term or geographic name entry element Cross-Over Studies
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Topical term or geographic name entry element Female
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Topical term or geographic name entry element Humans
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element Infusions, Intravenous
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element Male
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element Middle Aged
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Topical term or geographic name entry element Pilot Projects
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Topical term or geographic name entry element Recovery of Function/ph [Physiology]
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element Single-Blind Method
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Topical term or geographic name entry element Transplantation, Homologous/mt [Methods]
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element Treatment Outcome
651 ## - SUBJECT ADDED ENTRY--GEOGRAPHIC NAME
Institution MedStar Health Research Institute
651 ## - SUBJECT ADDED ENTRY--GEOGRAPHIC NAME
Institution MedStar Heart & Vascular Institute
657 ## - INDEX TERM--FUNCTION
Medline publication type Journal Article
700 ## - ADDED ENTRY--PERSONAL NAME
Local Authors Epstein, Stephen E
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Local Authors Lipinski, Michael J
790 ## - Authors
All authors Anderson AS, Butler J, Cole RT, Epstein SE, Gheorghiade M, Greene SJ, Kim RJ, Ko YA, Lipinski MJ, Margulies KB, Quyyumi AA, Sikora S, Skopicki HA, Tankovich NI, Wilcox JE
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DOI <a href="https://dx.doi.org/10.1161/CIRCRESAHA.116.309717">https://dx.doi.org/10.1161/CIRCRESAHA.116.309717</a>
Public note https://dx.doi.org/10.1161/CIRCRESAHA.116.309717
942 ## - ADDED ENTRY ELEMENTS (KOHA)
Koha item type Journal Article
Item type description Article
Holdings
Withdrawn status Lost status Damaged status Not for loan Collection Home library Current library Date acquired Total Checkouts Full call number Barcode Date last seen Price effective from Koha item type
          MedStar Authors Catalog MedStar Authors Catalog 04/28/2017   27856497 27856497 04/28/2017 04/28/2017 Journal Article

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