Evidence map›Paper›PMID 26470631›Full record

ArticleEuropean journal of heart failure2016

Cell-based therapies for cardiac repair: a meeting report on scientific observations and European regulatory viewpoints.

Martina Schüssler-Lenz, Claire Beuneu, Margarida Menezes-Ferreira, Veronika Jekerle, Jozef Bartunek, Steven Chamuleau, Patrick Celis, Pieter Doevendans, Maura O'Donovan, Jonathan Hill and 12 more

Open access · bronzeAbstract readConference Proceedings
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In one paragraph

Article in European journal of heart failure, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed
5.0field-weighted citation impact, top 5% 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

8 citing papers in PubMed, 33 citations in OpenAlex.

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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

22 authors at 15 institutions in 18 countries.

Martina Schüssler-LenzCommittee for Advanced Therapies (CAT), European Medicines Agency (EMA), Langen, Germany.
Claire BeuneuCommittee for Advanced Therapies (CAT), European Medicines Agency (EMA), Langen, Germany.
Margarida Menezes-FerreiraCommittee for Advanced Therapies (CAT), European Medicines Agency (EMA), Langen, Germany.
Veronika JekerleEuropean Medicines Agency (EMA), London, UK.
Jozef BartunekCardiovascular Center, OLV Hospital, Aalst, Belgium.
Steven ChamuleauUMC Utrecht, The Netherlands.
Patrick CelisCommittee for Advanced Therapies (CAT), European Medicines Agency (EMA), Langen, Germany.
Pieter DoevendansCommittee for Advanced Therapies (CAT), European Medicines Agency (EMA), Langen, Germany.
Maura O'DonovanCommittee for Advanced Therapies (CAT), European Medicines Agency (EMA), Langen, Germany.
Jonathan HillNHS, London, UK.
Marit HystadCommittee for Advanced Therapies (CAT), European Medicines Agency (EMA), Langen, Germany.
Stefan JovingeThe DeVos Cardiovascular Research Program, Grand Rapids, MI, USA.
Ján KyselovičCommittee for Advanced Therapies (CAT), European Medicines Agency (EMA), Langen, Germany.
Metoda Lipnik-StangeljCommittee for Advanced Therapies (CAT), European Medicines Agency (EMA), Langen, Germany.
Romaldas MaciulaitisCommittee for Advanced Therapies (CAT), European Medicines Agency (EMA), Langen, Germany.
Krishna PrasadMHRA, London, UK.
Anthony SamuelCommittee for Advanced Therapies (CAT), European Medicines Agency (EMA), Langen, Germany.
Olli TenhunenCommittee for Advanced Therapies (CAT), European Medicines Agency (EMA), Langen, Germany.
Torsten TonnDresden University, Dresden, Germany.
Giuseppe RosanoCardiovascular Working Party, European Medicines Agency (EMA).
Andreas ZeiherUniversity of Frankfurt, Frankfurt, Germany.
Paula SalmikangasCommittee for Advanced Therapies (CAT), European Medicines Agency (EMA), Langen, Germany.
European Medicines Agency · NLUniversity Medical Center Utrecht · NLComenius University Bratislava · SKFederal Agency for Nuclear Control · BEFinnish Medicines Agency Fimea · FIGoethe University Frankfurt · DEHealth and Safety Authority · IEHelen DeVos Children's Hospital · USLithuanian University of Health Sciences · LTManufacturing Technologies Association · GBOnze Lieve Vrouwziekenhuis Hospital · BESt George's, University of London · GBTU Dresden · DEUniversity of Ljubljana · SIZambia National Public Health Institute · ZM

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

In the past decade, novel cell-based products have been studied in patients with acute and chronic cardiac disease to assess whether these therapies are efficacious in improving heart function and preventing the development of end-stage heart failure. Cardiac indications studied include acute myocardial infarction (AMI), refractory angina, and chronic heart failure (CHF). Increased clinical activity, experience, and multiple challenges faced by developers have been recognized at the regulatory level. In May 2014, the Committee for Advanced Therapies (CAT) discussed in an expert meeting various cell-based medicinal products developed for cardiac repair, with a focus on non-manipulated bone marrow cells, sorted bone marrow or apheresis, and expanded cells, applied to patients with AMI or CHF. The intention was to share information, both scientific and regulatory, and to examine the challenges and opportunities in this field. These aspects were considered from the quality, and non-clinical and clinical perspectives, including current imaging techniques, with a focus on AMI and CHF. The scope of this overview is to present the European regulatory viewpoint on cell-based therapies for cardiac repair in the context of scientific observations.

Indexed as

RegenerationAnimalsCell TransplantationDisease Models, AnimalEuropeHeartHeart FailureHumansMyocardial InfarctionAdvanced therapy medicinal productsCell-based therapies for cardiac repairCommittee for Advanced TherapiesEuropean regulatory aspects

Identifiers

PMID26470631
OpenAlexW1907669044

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

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.