Evidence map›Paper›PMID 24444305›Full record

ArticleJournal of cellular and molecular medicine2014

Serum and supplement optimization for EU GMP-compliance in cardiospheres cell culture.

Isotta Chimenti, Roberto Gaetani, Elvira Forte, Francesco Angelini, Elena De Falco, Giuseppe Biondi Zoccai, Elisa Messina, Giacomo Frati, Alessandro Giacomello

Open access · goldAbstract read
In one paragraph

Article in Journal of cellular and molecular medicine, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 27 papers.

0numbers the graph read from it
0cells of the map it votes in
27citing papers in PubMed
2.1field-weighted citation impact, top 13% 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

27 citing papers in PubMed, 45 citations in OpenAlex.

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  13. Current challenges in three-dimensional bioprinting heart tissues for cardiac surgery.European journal of cardio-thoracic surgery : official journal of the European Association for Cardio-thoracic Surgery · 2020
    Review
  14. Article
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  16. Stem Cell Spheroids and Ex Vivo Niche Modeling: Rationalization and Scaling-Up.Journal of cardiovascular translational research · 2017
    Review
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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

9 authors at 3 institutions in 1 country.

Isotta ChimentiDepartment of Medical Surgical Sciences and Biotechnology, "Sapienza" University of Rome, Latina, Italy.
Roberto Gaetani
Elvira Forte
Francesco Angelini
Elena De Falco
Giuseppe Biondi Zoccai
Elisa Messina
Giacomo Frati
Alessandro Giacomello
Istituto Pasteur · ITSapienza University of Rome · ITIstituto Neurologico Mediterraneo · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Cardiac progenitor cells (CPCs) isolated as cardiospheres (CSs) and CS-derived cells (CDCs) are a promising tool for cardiac cell therapy in heart failure patients, having CDCs already been used in a phase I/II clinical trial. Culture standardization according to Good Manufacturing Practices (GMPs) is a mandatory step for clinical translation. One of the main issues raised is the use of xenogenic additives (e.g. FBS, foetal bovine serum) in cell culture media, which carries the risk of contamination with infectious viral/prion agents, and the possible induction of immunizing effects in the final recipient. In this study, B27 supplement and sera requirements to comply with European GMPs were investigated in CSs and CDCs cultures, in terms of process yield/efficiency and final cell product gene expression levels, as well as phenotype. B27- free CS cultures produced a significantly reduced yield and a 10-fold drop in c-kit expression levels versus B27+ media. Moreover, autologous human serum (aHS) and two different commercially available GMP AB HSs were compared with standard research-grade FBS. CPCs from all HSs explants had reduced growth rate, assumed a senescent-like morphology with time in culture, and/or displayed a significant shift towards the endothelial phenotype. Among three different GMP gamma-irradiated FBSs (giFBSs) tested, two provided unsatisfactory cell yields, while one performed optimally, in terms of CPCs yield/phenotype. In conclusion, the use of HSs for the isolation and expansion of CSs/CDCs has to be excluded because of altered proliferation and/or commitment, while media supplemented with B27 and the selected giFBS allows successful EU GMP-complying CPCs culture.

Indexed as

Cell Culture TechniquesAnimalsCattleCulture MediaGene Expression Regulation, DevelopmentalHumansProto-Oncogene Proteins c-kitSerumStem CellsCulture MediaProto-Oncogene Proteins c-kitadult stem cellscardiac cell therapycardiospheresGood Manufacturing Practice compliancehuman sera

Identifiers

PMID24444305
PMCPMC4000114
OpenAlexW1967934065

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.