Evidence map›Paper›PMID 27856208›Full record

Trial reportJournal of the American College of Cardiology2017

Randomized Comparison of Allogeneic Versus Autologous Mesenchymal Stem Cells for Nonischemic Dilated Cardiomyopathy: POSEIDON-DCM Trial.

Joshua M Hare, Darcy L DiFede, Angela C Rieger, Victoria Florea, Ana M Landin, Jill El-Khorazaty, Aisha Khan, Muzammil Mushtaq, Maureen H Lowery, John J Byrnes and 22 more

2 registry-linked trialsOpen access · hybridAbstract readComparative StudyRandomized Controlled Trial
In one paragraph

Trial report in Journal of the American College of Cardiology, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 197 papers, 7 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
197citing papers in PubMed, 7 pooled it
39.5field-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.

NCT01392625 phase1 / phase2completednot on this map

A Phase I/II, Randomized Pilot Study of the Comparative Safety and Efficacy of Transendocardial Injection of Autologous Mesenchymal Stem Cells Versus Allogeneic Mesenchymal Stem Cells in Patients With Non-ischemic Dilated Cardiomyopathy.

TypeinterventionalSponsorJoshua M HareRan2011 to 2017Enrolled37ConditionsNon-ischemic Dilated CardiomyopathyArmsAutologous hMSCs, Allogeneic hMSCs
NCT03514537 nasuspendednot on this mapstarted 2018, after this paper: background citation

Use of Autologous Stem/Stromal Cellular Stromal Vascular Fraction (cSVF) In Cases Of Frailty and Aging Processes Using Autologous Stem-Stromal Cell Infusion in Patients With Aging Frailty And Wellness

TypeinterventionalSponsorHealeon Medical IncRan2018 to 2028Enrolled200ConditionsFrail Elderly Syndrome, Aging, Degenerative DiseaseArmsMicrocannula harvest adipose stromal tissues, Centricyte 1000, Sterile Normal Saline IV Deployment of cSVF, Liberase, Saline Solution
3 · Its place in the literature

Who cites it

197 citing papers in PubMed, 7 syntheses or guidelines pooled it, 343 citations in OpenAlex.

  1. Pooled it
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  4. Stem cell therapy for dilated cardiomyopathy.The Cochrane database of systematic reviews · 2021
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  14. CD34Stem cells translational medicine · 2018
    Trial
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  17. Allogeneic Human Mesenchymal Stem Cell Infusions for Aging Frailty.The journals of gerontology. Series A, Biological sciences and medical sciences · 2017
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137 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

32 authors at 2 institutions in 1 country.

Joshua M HareInterdisciplinary Stem Cell Institute, University of Miami Miller School of Medicine, Miami, Florida; Department of Medicine, University of Miami Miller School of Medicine, Miami, Florida. Electronic address: JHare@med.miami.edu.
Darcy L DiFedeInterdisciplinary Stem Cell Institute, University of Miami Miller School of Medicine, Miami, Florida.
Angela C RiegerInterdisciplinary Stem Cell Institute, University of Miami Miller School of Medicine, Miami, Florida.
Victoria FloreaInterdisciplinary Stem Cell Institute, University of Miami Miller School of Medicine, Miami, Florida.
Ana M LandinInterdisciplinary Stem Cell Institute, University of Miami Miller School of Medicine, Miami, Florida.
Jill El-KhorazatyThe Emmes Corporation, Rockville, Maryland.
Aisha KhanInterdisciplinary Stem Cell Institute, University of Miami Miller School of Medicine, Miami, Florida.
Muzammil MushtaqDepartment of Medicine, University of Miami Miller School of Medicine, Miami, Florida.
Maureen H LoweryDepartment of Medicine, University of Miami Miller School of Medicine, Miami, Florida.
John J ByrnesDepartment of Medicine, University of Miami Miller School of Medicine, Miami, Florida.
Robert C HendelDepartment of Medicine, University of Miami Miller School of Medicine, Miami, Florida.
Mauricio G CohenDepartment of Medicine, University of Miami Miller School of Medicine, Miami, Florida.
Carlos E AlfonsoDepartment of Medicine, University of Miami Miller School of Medicine, Miami, Florida.
Krystalenia ValasakiInterdisciplinary Stem Cell Institute, University of Miami Miller School of Medicine, Miami, Florida.
Marietsy V PujolInterdisciplinary Stem Cell Institute, University of Miami Miller School of Medicine, Miami, Florida.
Samuel GolpanianDepartment of Surgery, University of Miami Miller School of Medicine, Miami, Florida.
Eduard GhersinDepartment of Radiology, University of Miami Miller School of Medicine, Miami, Florida.
Joel E FishmanDepartment of Radiology, University of Miami Miller School of Medicine, Miami, Florida.
Pradip PattanyDepartment of Radiology, University of Miami Miller School of Medicine, Miami, Florida.
Samirah A GomesInterdisciplinary Stem Cell Institute, University of Miami Miller School of Medicine, Miami, Florida.
Cindy DelgadoInterdisciplinary Stem Cell Institute, University of Miami Miller School of Medicine, Miami, Florida.
Roberto MikiDepartment of Medicine, University of Miami Miller School of Medicine, Miami, Florida.
Fouad AbuzeidInterdisciplinary Stem Cell Institute, University of Miami Miller School of Medicine, Miami, Florida.
Mayra Vidro-CasianoInterdisciplinary Stem Cell Institute, University of Miami Miller School of Medicine, Miami, Florida.
Courtney PremerInterdisciplinary Stem Cell Institute, University of Miami Miller School of Medicine, Miami, Florida.
Audrey MedinaInterdisciplinary Stem Cell Institute, University of Miami Miller School of Medicine, Miami, Florida.
Valeria PorrasInterdisciplinary Stem Cell Institute, University of Miami Miller School of Medicine, Miami, Florida.
Konstantinos E HatzistergosInterdisciplinary Stem Cell Institute, University of Miami Miller School of Medicine, Miami, Florida.
Erica AndersonThe Emmes Corporation, Rockville, Maryland.
Adam MendizabalThe Emmes Corporation, Rockville, Maryland.
Raul MitraniDepartment of Medicine, University of Miami Miller School of Medicine, Miami, Florida.
Alan W HeldmanDepartment of Medicine, University of Miami Miller School of Medicine, Miami, Florida.
University of Miami · USEmmes (United States) · US

Funding

Cell Based Therapy for Non-Ischemic Dilated CardiomyopathyUM1HL113460 · NHLBI · UNIVERSITY OF MIAMI SCHOOL OF MEDICINE · PI HARE, JOSHUA M · 2012 to 2018
$4.3M
Stem Cells for Dilated CardiomyopathyR01HL110737 · NHLBI · UNIVERSITY OF MIAMI SCHOOL OF MEDICINE · PI HARE, JOSHUA M · 2011 to 2015
$3.2M
NHLBI NIH HHS R01 HL110737NHLBI NIH HHS UM1 HL113460
6 · The paper itself

Abstract

backgroundAlthough human mesenchymal stem cells (hMSCs) have been tested in ischemic cardiomyopathy, few studies exist in chronic nonischemic dilated cardiomyopathy (NIDCM).

objectivesThe authors conducted a randomized comparison of safety and efficacy of autologous (auto) versus allogeneic (allo) bone marrow-derived hMSCs in NIDCM.

methodsThirty-seven patients were randomized to either allo- or auto-hMSCs in a 1:1 ratio. Patients were recruited between December 2011 and July 2015 at the University of Miami Hospital. Patients received hMSCs (100 million) by transendocardial stem cell injection in 10 left ventricular sites. Treated patients were evaluated at baseline, 30 days, and 3-, 6-, and 12-months for safety (serious adverse events [SAE]), and efficacy endpoints: ejection fraction, Minnesota Living with Heart Failure Questionnaire, 6-min walk test, major adverse cardiac events, and immune biomarkers.

resultsThere were no 30-day treatment-emergent SAEs. Twelve-month SAE incidence was 28.2% with allo-hMSCs versus 63.5% with auto-hMSCs (p = 0.1004 for the comparison). One allo-hMSC patient developed an elevated (>80) donor-specific calculated panel reactive antibody level. The ejection fraction increased in allo-hMSC patients by 8.0 percentage points (p = 0.004) compared with 5.4 with auto-hMSCs (p = 0.116; allo vs. auto p = 0.4887). The 6-min walk test increased with allo-hMSCs by 37.0 m (p = 0.04), but not auto-hMSCs at 7.3 m (p = 0.71; auto vs. allo p = 0.0168). MLHFQ score decreased in allo-hMSC (p = 0.0022) and auto-hMSC patients (p = 0.463; auto vs. allo p = 0.172). The major adverse cardiac event rate was lower, too, in the allo group (p = 0.0186 vs. auto). Tumor necrosis factor-α decreased (p = 0.0001 for each), to a greater extent with allo-hMSCs versus auto-hMSCs at 6 months (p = 0.05).

conclusionsThese findings demonstrated safety and clinically meaningful efficacy of allo-hMSC versus auto-hMSC in NIDCM patients. Pivotal trials of allo-hMSCs are warranted based on these results. (Percutaneous Stem Cell Injection Delivery Effects on Neomyogenesis in Dilated Cardiomyopathy [PoseidonDCM]; NCT01392625).

Indexed as

Cardiomyopathy, DilatedFemaleHumansMaleMesenchymal Stem Cell TransplantationMiddle AgedSafetyTransplantation, AutologousTransplantation, HomologousTreatment OutcomeTumor Necrosis Factor-alphaTumor Necrosis Factor-alphaendothelial functionheart failureidiopathic dilated cardiomyopathyimmune biomarkerstem cell therapy

Identifiers

PMID27856208
PMCPMC5291766
OpenAlexW2549128727

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.