Evidence map›Paper›PMID 32053144›Full record

Trial reportCardiovascular research2020

The impact of patient sex on the response to intramyocardial mesenchymal stem cell administration in patients with non-ischaemic dilated cardiomyopathy.

Victoria Florea, Angela C Rieger, Makoto Natsumeda, Bryon A Tompkins, Monisha N Banerjee, Ivonne H Schulman, Courtney Premer, Aisha Khan, Krystalenia Valasaki, Bettina Heidecker and 4 more

Open access · greenAbstract readClinical Trial, Phase IClinical Trial, Phase IIComparative Study
In one paragraph

Trial report in Cardiovascular research, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed
1.8field-weighted citation impact, top 15% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

9 citing papers in PubMed, 15 citations in OpenAlex.

  1. Review
  2. Review
  3. Article
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  6. Demographic representation in clinical trials for cell-based therapy.Contemporary clinical trials communications · 2021
    Article
  7. Review
  8. Article
  9. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

14 authors at 2 institutions in 2 countries.

Victoria FloreaInterdisciplinary Stem Cell Institute, University of Miami Miller School of Medicine, Biomedical Research Building - 9th Floor 1501 NW 10th Ave, Miami, FL 33136, USA.
Angela C RiegerInterdisciplinary Stem Cell Institute, University of Miami Miller School of Medicine, Biomedical Research Building - 9th Floor 1501 NW 10th Ave, Miami, FL 33136, USA.
Makoto NatsumedaInterdisciplinary Stem Cell Institute, University of Miami Miller School of Medicine, Biomedical Research Building - 9th Floor 1501 NW 10th Ave, Miami, FL 33136, USA.
Bryon A TompkinsInterdisciplinary Stem Cell Institute, University of Miami Miller School of Medicine, Biomedical Research Building - 9th Floor 1501 NW 10th Ave, Miami, FL 33136, USA.
Monisha N BanerjeeInterdisciplinary Stem Cell Institute, University of Miami Miller School of Medicine, Biomedical Research Building - 9th Floor 1501 NW 10th Ave, Miami, FL 33136, USA.
Ivonne H SchulmanInterdisciplinary Stem Cell Institute, University of Miami Miller School of Medicine, Biomedical Research Building - 9th Floor 1501 NW 10th Ave, Miami, FL 33136, USA.
Courtney PremerInterdisciplinary Stem Cell Institute, University of Miami Miller School of Medicine, Biomedical Research Building - 9th Floor 1501 NW 10th Ave, Miami, FL 33136, USA.
Aisha KhanInterdisciplinary Stem Cell Institute, University of Miami Miller School of Medicine, Biomedical Research Building - 9th Floor 1501 NW 10th Ave, Miami, FL 33136, USA.
Krystalenia ValasakiInterdisciplinary Stem Cell Institute, University of Miami Miller School of Medicine, Biomedical Research Building - 9th Floor 1501 NW 10th Ave, Miami, FL 33136, USA.
Bettina HeideckerDepartment of Cardiology, Charite Berlin University of Medicine, Berlin, Germany.
Alejandro ManteroDepartment of Public Health Sciences, University of Miami Miller School of Medicine, Miami, FL, USA.
Wayne BalkanInterdisciplinary Stem Cell Institute, University of Miami Miller School of Medicine, Biomedical Research Building - 9th Floor 1501 NW 10th Ave, Miami, FL 33136, USA.
Raul D MitraniInterdisciplinary Stem Cell Institute, University of Miami Miller School of Medicine, Biomedical Research Building - 9th Floor 1501 NW 10th Ave, Miami, FL 33136, USA.
Joshua M HareInterdisciplinary Stem Cell Institute, University of Miami Miller School of Medicine, Biomedical Research Building - 9th Floor 1501 NW 10th Ave, Miami, FL 33136, USA.
University of Miami · USCharité - Universitätsmedizin Berlin · DE

Funding

Miami Clinical and Translational Science InstituteUL1TR002736 · NCATS · UNIVERSITY OF MIAMI SCHOOL OF MEDICINE · PI CARRASQUILLO, OLVEEN, KOBETZ, ERIN N · 2018 to 2022
$23.2M
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
Nitric Oxide and sex differences in cardiac repairR01HL137355 · NHLBI · UNIVERSITY OF MIAMI SCHOOL OF MEDICINE · PI HARE, JOSHUA M · 2017 to 2020
$1.6M
NCATS NIH HHS UL1 TR002736NHLBI NIH HHS R01 HL110737NHLBI NIH HHS R01 HL137355NHLBI NIH HHS UM1 HL113460
6 · The paper itself

Abstract

aimsSex differences impact the occurrence, presentation, prognosis, and response to therapy in heart disease. Particularly, the phenotypic presentation of patients with non-ischaemic dilated cardiomyopathy (NIDCM) differs between men and women. However, whether the response to mesenchymal stem cell (MSC) therapy is influenced by sex remains unknown. We hypothesize that males and females with NIDCM respond similarly to MSC therapy. METHODS AND

resultsMale (n = 24) and female (n = 10) patients from the POSEIDON-DCM trial who received MSCs via transendocardial injections were evaluated over 12 months. Endothelial function was measured at baseline and 3 months post-transendocardial stem cell injection (TESI). At baseline, ejection fraction (EF) was lower (P = 0.004) and end-diastolic volume (EDV; P = 0.0002) and end-systolic volume (ESV; P = 0.0002) were higher in males vs. females. In contrast, baseline demographic characteristics, Minnesota Living with Heart Failure Questionnaire (MLHFQ), and 6-min walk test (6MWT) were similar between groups. EF improved in males by 6.2 units (P = 0.04) and in females by 8.6 units (P = 0.04; males vs. females, P = 0.57). EDV and ESV were unchanged over time. The MLHFQ score, New York Heart Association (NYHA) class, endothelial progenitor cell-colony forming units, and serum tumour necrosis factor alpha improved similarly in both groups.

conclusionDespite major differences in phenotypic presentation of NIDCM in males and females, this study is the first of its kind to demonstrate that MSC therapy improves a variety of parameters in NIDCM irrespective of patient sex. These findings have important clinical and pathophysiologic implications regarding the impact of sex on responses to cell-based therapy for NIDCM.

Indexed as

Mesenchymal Stem Cell TransplantationAdultAgedBiomarkersCardiomyopathy, DilatedEndothelial Progenitor CellsExercise ToleranceFemaleFloridaFunctional StatusHealth Status DisparitiesHumansMaleMiddle AgedQuality of LifeRecovery of FunctionBiomarkersTNF protein, humanTumor Necrosis Factor-alphaCell therapyDilated cardiomyopathyHeart failureMesenchymal stem cellsSex

Identifiers

PMID32053144
PMCPMC7584465
OpenAlexW3006115657

What OpenQuestion holds

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Registered trials

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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.