Evidence map›Paper›PMID 27856497›Full record

Trial reportCirculation research2017

Intravenous Allogeneic Mesenchymal Stem Cells for Nonischemic Cardiomyopathy: Safety and Efficacy Results of a Phase II-A Randomized Trial.

Javed Butler, Stephen E Epstein, Stephen J Greene, Arshed A Quyyumi, Sergey Sikora, Raymond J Kim, Allen S Anderson, Jane E Wilcox, Nikolai I Tankovich, Michael J Lipinski and 5 more

Registry-linked trialAbstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Circulation research, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02467387 (A Phase IIa Randomized Study to Assess the Safety, Tolerability, and Preliminary Efficacy of a Single Intravenous Dose of Ischemia-tolerant Allogeneic Mesenchymal Bone Marrow Cells to Subjects With Non-ischemic Heart Failure), which is not on this map. Cited by 104 papers, 7 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
104citing papers in PubMed, 7 pooled it
17.3field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02467387 phase2completednot on this map

A Phase IIa Randomized Study to Assess the Safety, Tolerability, and Preliminary Efficacy of a Single Intravenous Dose of Ischemia-tolerant Allogeneic Mesenchymal Bone Marrow Cells to Subjects With Non-ischemic Heart Failure

TypeinterventionalSponsorCardioCell LLCRan2014 to 2017Enrolled23ConditionsNon-Ischemic Heart FailureArmsAllogeneic Mesenchymal Bone Marrow Cells (aMBMC), Lactated Ringer's Solution
3 · Its place in the literature

Who cites it

104 citing papers in PubMed, 7 syntheses or guidelines pooled it, 180 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Pooled it
  5. Pooled it
  6. Stem cell therapy for dilated cardiomyopathy.The Cochrane database of systematic reviews · 2021
    Pooled it
  7. Pooled it
  8. Trial
  9. Trial
  10. Trial
  11. Review
  12. Mesenchymal stem cells for recurrent miscarriage.Journal of translational medicine · 2026
    Review
  13. Article
  14. Review
  15. Article
  16. Review
  17. Review
  18. Observational
  19. Article
  20. Article

44 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

15 authors at 6 institutions in 1 country.

Javed ButlerFrom the Division of Cardiology, Department of Medicine, Stony Brook University, NY (J.B., H.A.S.); MedStar Heart and Vascular Institute, MedStar Washington Hospital Center, Washington, DC (S.E.E., M.J.L.); Division of Cardiology, Department of Medicine, Duke University Medical Center, Durham, NC (S.J.G., R.J.K.); Division of Cardiology, Department of Medicine, Emory University, Atlanta, GA (A.A.Q., R.T.C.); CardioCell LLC, San Diego, CA (S.S.); Division of Cardiology, Department of Medicine, Northwestern University Feinberg School of Medicine, Chicago, IL (A.S.A., J.E.W.); Stemedica Cell Technologies Inc, San Diego, CA (N.I.T.); Department of Biostatistics and Bioinformatics, Emory University, Atlanta, GA (Y.-A.K.); Division of Cardiology, Department of Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia (K.B.M.); and Center for Cardiovascular Innovation, Northwestern University Feinberg School of Medicine, Chicago, IL (M.G.). javed.butler@stonybrookmedicine.edu.
Stephen E EpsteinFrom the Division of Cardiology, Department of Medicine, Stony Brook University, NY (J.B., H.A.S.); MedStar Heart and Vascular Institute, MedStar Washington Hospital Center, Washington, DC (S.E.E., M.J.L.); Division of Cardiology, Department of Medicine, Duke University Medical Center, Durham, NC (S.J.G., R.J.K.); Division of Cardiology, Department of Medicine, Emory University, Atlanta, GA (A.A.Q., R.T.C.); CardioCell LLC, San Diego, CA (S.S.); Division of Cardiology, Department of Medicine, Northwestern University Feinberg School of Medicine, Chicago, IL (A.S.A., J.E.W.); Stemedica Cell Technologies Inc, San Diego, CA (N.I.T.); Department of Biostatistics and Bioinformatics, Emory University, Atlanta, GA (Y.-A.K.); Division of Cardiology, Department of Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia (K.B.M.); and Center for Cardiovascular Innovation, Northwestern University Feinberg School of Medicine, Chicago, IL (M.G.).
Stephen J GreeneFrom the Division of Cardiology, Department of Medicine, Stony Brook University, NY (J.B., H.A.S.); MedStar Heart and Vascular Institute, MedStar Washington Hospital Center, Washington, DC (S.E.E., M.J.L.); Division of Cardiology, Department of Medicine, Duke University Medical Center, Durham, NC (S.J.G., R.J.K.); Division of Cardiology, Department of Medicine, Emory University, Atlanta, GA (A.A.Q., R.T.C.); CardioCell LLC, San Diego, CA (S.S.); Division of Cardiology, Department of Medicine, Northwestern University Feinberg School of Medicine, Chicago, IL (A.S.A., J.E.W.); Stemedica Cell Technologies Inc, San Diego, CA (N.I.T.); Department of Biostatistics and Bioinformatics, Emory University, Atlanta, GA (Y.-A.K.); Division of Cardiology, Department of Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia (K.B.M.); and Center for Cardiovascular Innovation, Northwestern University Feinberg School of Medicine, Chicago, IL (M.G.).
Arshed A QuyyumiFrom the Division of Cardiology, Department of Medicine, Stony Brook University, NY (J.B., H.A.S.); MedStar Heart and Vascular Institute, MedStar Washington Hospital Center, Washington, DC (S.E.E., M.J.L.); Division of Cardiology, Department of Medicine, Duke University Medical Center, Durham, NC (S.J.G., R.J.K.); Division of Cardiology, Department of Medicine, Emory University, Atlanta, GA (A.A.Q., R.T.C.); CardioCell LLC, San Diego, CA (S.S.); Division of Cardiology, Department of Medicine, Northwestern University Feinberg School of Medicine, Chicago, IL (A.S.A., J.E.W.); Stemedica Cell Technologies Inc, San Diego, CA (N.I.T.); Department of Biostatistics and Bioinformatics, Emory University, Atlanta, GA (Y.-A.K.); Division of Cardiology, Department of Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia (K.B.M.); and Center for Cardiovascular Innovation, Northwestern University Feinberg School of Medicine, Chicago, IL (M.G.).
Sergey SikoraFrom the Division of Cardiology, Department of Medicine, Stony Brook University, NY (J.B., H.A.S.); MedStar Heart and Vascular Institute, MedStar Washington Hospital Center, Washington, DC (S.E.E., M.J.L.); Division of Cardiology, Department of Medicine, Duke University Medical Center, Durham, NC (S.J.G., R.J.K.); Division of Cardiology, Department of Medicine, Emory University, Atlanta, GA (A.A.Q., R.T.C.); CardioCell LLC, San Diego, CA (S.S.); Division of Cardiology, Department of Medicine, Northwestern University Feinberg School of Medicine, Chicago, IL (A.S.A., J.E.W.); Stemedica Cell Technologies Inc, San Diego, CA (N.I.T.); Department of Biostatistics and Bioinformatics, Emory University, Atlanta, GA (Y.-A.K.); Division of Cardiology, Department of Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia (K.B.M.); and Center for Cardiovascular Innovation, Northwestern University Feinberg School of Medicine, Chicago, IL (M.G.).
Raymond J KimFrom the Division of Cardiology, Department of Medicine, Stony Brook University, NY (J.B., H.A.S.); MedStar Heart and Vascular Institute, MedStar Washington Hospital Center, Washington, DC (S.E.E., M.J.L.); Division of Cardiology, Department of Medicine, Duke University Medical Center, Durham, NC (S.J.G., R.J.K.); Division of Cardiology, Department of Medicine, Emory University, Atlanta, GA (A.A.Q., R.T.C.); CardioCell LLC, San Diego, CA (S.S.); Division of Cardiology, Department of Medicine, Northwestern University Feinberg School of Medicine, Chicago, IL (A.S.A., J.E.W.); Stemedica Cell Technologies Inc, San Diego, CA (N.I.T.); Department of Biostatistics and Bioinformatics, Emory University, Atlanta, GA (Y.-A.K.); Division of Cardiology, Department of Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia (K.B.M.); and Center for Cardiovascular Innovation, Northwestern University Feinberg School of Medicine, Chicago, IL (M.G.).
Allen S AndersonFrom the Division of Cardiology, Department of Medicine, Stony Brook University, NY (J.B., H.A.S.); MedStar Heart and Vascular Institute, MedStar Washington Hospital Center, Washington, DC (S.E.E., M.J.L.); Division of Cardiology, Department of Medicine, Duke University Medical Center, Durham, NC (S.J.G., R.J.K.); Division of Cardiology, Department of Medicine, Emory University, Atlanta, GA (A.A.Q., R.T.C.); CardioCell LLC, San Diego, CA (S.S.); Division of Cardiology, Department of Medicine, Northwestern University Feinberg School of Medicine, Chicago, IL (A.S.A., J.E.W.); Stemedica Cell Technologies Inc, San Diego, CA (N.I.T.); Department of Biostatistics and Bioinformatics, Emory University, Atlanta, GA (Y.-A.K.); Division of Cardiology, Department of Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia (K.B.M.); and Center for Cardiovascular Innovation, Northwestern University Feinberg School of Medicine, Chicago, IL (M.G.).
Jane E WilcoxFrom the Division of Cardiology, Department of Medicine, Stony Brook University, NY (J.B., H.A.S.); MedStar Heart and Vascular Institute, MedStar Washington Hospital Center, Washington, DC (S.E.E., M.J.L.); Division of Cardiology, Department of Medicine, Duke University Medical Center, Durham, NC (S.J.G., R.J.K.); Division of Cardiology, Department of Medicine, Emory University, Atlanta, GA (A.A.Q., R.T.C.); CardioCell LLC, San Diego, CA (S.S.); Division of Cardiology, Department of Medicine, Northwestern University Feinberg School of Medicine, Chicago, IL (A.S.A., J.E.W.); Stemedica Cell Technologies Inc, San Diego, CA (N.I.T.); Department of Biostatistics and Bioinformatics, Emory University, Atlanta, GA (Y.-A.K.); Division of Cardiology, Department of Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia (K.B.M.); and Center for Cardiovascular Innovation, Northwestern University Feinberg School of Medicine, Chicago, IL (M.G.).
Nikolai I TankovichFrom the Division of Cardiology, Department of Medicine, Stony Brook University, NY (J.B., H.A.S.); MedStar Heart and Vascular Institute, MedStar Washington Hospital Center, Washington, DC (S.E.E., M.J.L.); Division of Cardiology, Department of Medicine, Duke University Medical Center, Durham, NC (S.J.G., R.J.K.); Division of Cardiology, Department of Medicine, Emory University, Atlanta, GA (A.A.Q., R.T.C.); CardioCell LLC, San Diego, CA (S.S.); Division of Cardiology, Department of Medicine, Northwestern University Feinberg School of Medicine, Chicago, IL (A.S.A., J.E.W.); Stemedica Cell Technologies Inc, San Diego, CA (N.I.T.); Department of Biostatistics and Bioinformatics, Emory University, Atlanta, GA (Y.-A.K.); Division of Cardiology, Department of Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia (K.B.M.); and Center for Cardiovascular Innovation, Northwestern University Feinberg School of Medicine, Chicago, IL (M.G.).
Michael J LipinskiFrom the Division of Cardiology, Department of Medicine, Stony Brook University, NY (J.B., H.A.S.); MedStar Heart and Vascular Institute, MedStar Washington Hospital Center, Washington, DC (S.E.E., M.J.L.); Division of Cardiology, Department of Medicine, Duke University Medical Center, Durham, NC (S.J.G., R.J.K.); Division of Cardiology, Department of Medicine, Emory University, Atlanta, GA (A.A.Q., R.T.C.); CardioCell LLC, San Diego, CA (S.S.); Division of Cardiology, Department of Medicine, Northwestern University Feinberg School of Medicine, Chicago, IL (A.S.A., J.E.W.); Stemedica Cell Technologies Inc, San Diego, CA (N.I.T.); Department of Biostatistics and Bioinformatics, Emory University, Atlanta, GA (Y.-A.K.); Division of Cardiology, Department of Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia (K.B.M.); and Center for Cardiovascular Innovation, Northwestern University Feinberg School of Medicine, Chicago, IL (M.G.).
Yi-An KoFrom the Division of Cardiology, Department of Medicine, Stony Brook University, NY (J.B., H.A.S.); MedStar Heart and Vascular Institute, MedStar Washington Hospital Center, Washington, DC (S.E.E., M.J.L.); Division of Cardiology, Department of Medicine, Duke University Medical Center, Durham, NC (S.J.G., R.J.K.); Division of Cardiology, Department of Medicine, Emory University, Atlanta, GA (A.A.Q., R.T.C.); CardioCell LLC, San Diego, CA (S.S.); Division of Cardiology, Department of Medicine, Northwestern University Feinberg School of Medicine, Chicago, IL (A.S.A., J.E.W.); Stemedica Cell Technologies Inc, San Diego, CA (N.I.T.); Department of Biostatistics and Bioinformatics, Emory University, Atlanta, GA (Y.-A.K.); Division of Cardiology, Department of Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia (K.B.M.); and Center for Cardiovascular Innovation, Northwestern University Feinberg School of Medicine, Chicago, IL (M.G.).
Kenneth B MarguliesFrom the Division of Cardiology, Department of Medicine, Stony Brook University, NY (J.B., H.A.S.); MedStar Heart and Vascular Institute, MedStar Washington Hospital Center, Washington, DC (S.E.E., M.J.L.); Division of Cardiology, Department of Medicine, Duke University Medical Center, Durham, NC (S.J.G., R.J.K.); Division of Cardiology, Department of Medicine, Emory University, Atlanta, GA (A.A.Q., R.T.C.); CardioCell LLC, San Diego, CA (S.S.); Division of Cardiology, Department of Medicine, Northwestern University Feinberg School of Medicine, Chicago, IL (A.S.A., J.E.W.); Stemedica Cell Technologies Inc, San Diego, CA (N.I.T.); Department of Biostatistics and Bioinformatics, Emory University, Atlanta, GA (Y.-A.K.); Division of Cardiology, Department of Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia (K.B.M.); and Center for Cardiovascular Innovation, Northwestern University Feinberg School of Medicine, Chicago, IL (M.G.).
Robert T ColeFrom the Division of Cardiology, Department of Medicine, Stony Brook University, NY (J.B., H.A.S.); MedStar Heart and Vascular Institute, MedStar Washington Hospital Center, Washington, DC (S.E.E., M.J.L.); Division of Cardiology, Department of Medicine, Duke University Medical Center, Durham, NC (S.J.G., R.J.K.); Division of Cardiology, Department of Medicine, Emory University, Atlanta, GA (A.A.Q., R.T.C.); CardioCell LLC, San Diego, CA (S.S.); Division of Cardiology, Department of Medicine, Northwestern University Feinberg School of Medicine, Chicago, IL (A.S.A., J.E.W.); Stemedica Cell Technologies Inc, San Diego, CA (N.I.T.); Department of Biostatistics and Bioinformatics, Emory University, Atlanta, GA (Y.-A.K.); Division of Cardiology, Department of Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia (K.B.M.); and Center for Cardiovascular Innovation, Northwestern University Feinberg School of Medicine, Chicago, IL (M.G.).
Hal A SkopickiFrom the Division of Cardiology, Department of Medicine, Stony Brook University, NY (J.B., H.A.S.); MedStar Heart and Vascular Institute, MedStar Washington Hospital Center, Washington, DC (S.E.E., M.J.L.); Division of Cardiology, Department of Medicine, Duke University Medical Center, Durham, NC (S.J.G., R.J.K.); Division of Cardiology, Department of Medicine, Emory University, Atlanta, GA (A.A.Q., R.T.C.); CardioCell LLC, San Diego, CA (S.S.); Division of Cardiology, Department of Medicine, Northwestern University Feinberg School of Medicine, Chicago, IL (A.S.A., J.E.W.); Stemedica Cell Technologies Inc, San Diego, CA (N.I.T.); Department of Biostatistics and Bioinformatics, Emory University, Atlanta, GA (Y.-A.K.); Division of Cardiology, Department of Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia (K.B.M.); and Center for Cardiovascular Innovation, Northwestern University Feinberg School of Medicine, Chicago, IL (M.G.).
Mihai GheorghiadeFrom the Division of Cardiology, Department of Medicine, Stony Brook University, NY (J.B., H.A.S.); MedStar Heart and Vascular Institute, MedStar Washington Hospital Center, Washington, DC (S.E.E., M.J.L.); Division of Cardiology, Department of Medicine, Duke University Medical Center, Durham, NC (S.J.G., R.J.K.); Division of Cardiology, Department of Medicine, Emory University, Atlanta, GA (A.A.Q., R.T.C.); CardioCell LLC, San Diego, CA (S.S.); Division of Cardiology, Department of Medicine, Northwestern University Feinberg School of Medicine, Chicago, IL (A.S.A., J.E.W.); Stemedica Cell Technologies Inc, San Diego, CA (N.I.T.); Department of Biostatistics and Bioinformatics, Emory University, Atlanta, GA (Y.-A.K.); Division of Cardiology, Department of Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia (K.B.M.); and Center for Cardiovascular Innovation, Northwestern University Feinberg School of Medicine, Chicago, IL (M.G.).
Emory University · USStony Brook University · USMedStar Heart & Vascular Institute · USUniversity of Pennsylvania · USMedStar Washington Hospital Center · USNorthwestern University · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

rationalePotential 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.

objectiveTo assess the safety and preliminary efficacy of intravenously administered ischemia-tolerant MSCs (itMSCs) in patients with nonischemic cardiomyopathy. METHODS AND

resultsThis 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 (1.5×10

conclusionsIn 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. CLINICAL

trial registrationURL: http://www.clinicaltrials.gov. Unique identifier: NCT02467387.

Indexed as

Health StatusAdultCardiomyopathiesCross-Over StudiesFemaleHumansInfusions, IntravenousMaleMesenchymal Stem Cell TransplantationMiddle AgedPilot ProjectsRecovery of FunctionSingle-Blind MethodTransplantation, HomologousTreatment Outcomecardiomyopathyclinical trialheart failurenonischemicstem cellsviable myocardium

Identifiers

PMID27856497
OpenAlexW2556624660

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.