Evidence map›Paper›PMID 28880460›Full record

ArticleStem cells translational medicine2017

Cryopreserved Off-the-Shelf Allogeneic Adipose-Derived Stromal Cells for Therapy in Patients with Ischemic Heart Disease and Heart Failure-A Safety Study.

Jens Kastrup, Mandana Haack-Sørensen, Morten Juhl, Rebekka Harary Søndergaard, Bjarke Follin, Lisbeth Drozd Lund, Ellen Mønsted Johansen, Abbas Ali Qayyum, Anders Bruun Mathiasen, Erik Jørgensen and 4 more

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase I
PubMed Full text at PMC Publisher
In one paragraph

Article in Stem cells translational medicine, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03797092 (Stem Cell Therapy in Non-IschEmic Non-treatable Dilated CardiomyopathiEs II), which is not on this map. Cited by 74 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
74citing papers in PubMed, 4 pooled it
5.4field-weighted citation impact, top 4% 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.

NCT03797092 phase1 / phase2unknown statusnot on this mapstarted 2019, after this paper: background citation

Stem Cell Therapy in Non-IschEmic Non-treatable Dilated CardiomyopathiEs II: a Pilot Study

TypeinterventionalSponsorJKastrupRan2019 to 2021Enrolled30ConditionsNon-ischemic Dilated CardiomyopathyArmsAllogeneic adipose-derived stromal cells (CSCC_ASC), Control group
3 · Its place in the literature

Who cites it

74 citing papers in PubMed, 4 syntheses or guidelines pooled it, 121 citations in OpenAlex.

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

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 3 institutions in 1 country.

Jens KastrupDepartment of Cardiology, Rigshospitalet, University of Copenhagen, Denmark.ORCID 0000-0002-3668-5393
Mandana Haack-SørensenCardiology Stem Cell Centre, Rigshospitalet, University of Copenhagen, Denmark.
Morten JuhlCardiology Stem Cell Centre, Rigshospitalet, University of Copenhagen, Denmark.
Rebekka Harary SøndergaardCardiology Stem Cell Centre, Rigshospitalet, University of Copenhagen, Denmark.
Bjarke FollinCardiology Stem Cell Centre, Rigshospitalet, University of Copenhagen, Denmark.
Lisbeth Drozd LundCardiology Stem Cell Centre, Rigshospitalet, University of Copenhagen, Denmark.
Ellen Mønsted JohansenDepartment of Cardiology, Rigshospitalet, University of Copenhagen, Denmark.
Abbas Ali QayyumDepartment of Cardiology, Rigshospitalet, University of Copenhagen, Denmark.
Anders Bruun MathiasenDepartment of Cardiology, Rigshospitalet, University of Copenhagen, Denmark.
Erik JørgensenDepartment of Cardiology, Rigshospitalet, University of Copenhagen, Denmark.
Steffen HelqvistDepartment of Cardiology, Rigshospitalet, University of Copenhagen, Denmark.
Jens Jørgen ElbergDepartment of Plastic Surgery, Breast Surgery & Burns, Rigshospitalet, University of Copenhagen, Denmark.
Helle BruunsgaardDepartment of Clinical Immunology, Rigshospitalet, University of Copenhagen, Denmark.
Annette EkblondCardiology Stem Cell Centre, Rigshospitalet, University of Copenhagen, Denmark.
University of Copenhagen · DKRigshospitalet · DKCopenhagen University Hospital · DK

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The present first-in-human clinical trial evaluated the safety and feasibility of a newly developed and cryopreserved Cardiology Stem Cell Centre adipose-derived stromal cell (CSCC_ASC) product from healthy donors for intramyocardial injection in ten patients with ischemic heart disease and ischemic heart failure (IHF). Batches of CSCC_ASC were isolated from three healthy donors by liposuction from abdominal adipose tissue. Adipose mesenchymal stromal cells were culture expanded in bioreactors without the use of animal constituents, cryopreserved, and stored in vials in nitrogen dry-storage containers until use. Direct injection of CSCC_ASC into the myocardium did not cause any complications or serious adverse events related to either treatment or cell administration in a 6-month follow-up period. Four out of ten heart failure patients developed donor-specific de novo human leukocyte antigen (HLA) class I antibodies, and two out of ten patients had donor-specific HLA antibodies already at baseline. There were no clinical symptoms or changes in inflammatory parameters in the follow-up period that indicated an ongoing immune response. There was a tendency toward improvement in cardiac function after CSCC_ASC treatment at 6-month follow-up: left ventricular end systolic volume decreased and left ventricular ejection fraction increased. In addition, exercise capacity increased. These changes were independent of the presence or absence of HLA antibodies. It is concluded that the newly developed cryopreserved product CSCC_ASC from healthy donors was a safe and feasible treatment. We observed a tendency toward efficacy in patients with IHF. These findings have to be confirmed in larger placebo controlled clinical trials. Stem Cells Translational Medicine 2017;6:1963-1971.

Indexed as

Adipose TissueAdultAgedCryopreservationFemaleHeart FailureHumansMaleMesenchymal Stem CellsMesenchymal Stem Cell TransplantationMiddle AgedMyocardial IschemiaTransplantation, HomologousAdipose stem cellsCardiacCellular therapyClinical trialMesenchymal stem cellsSomatic cell therapyStromal cellsTissue regeneration

Identifiers

PMID28880460
PMCPMC6430047
OpenAlexW2751753120

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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.