Evidence map›Paper›PMID 28526045›Full record

ArticleJournal of translational medicine2017

Standardization of platelet releasate products for clinical applications in cell therapy: a mathematical approach.

Francesco Agostini, Jerry Polesel, Monica Battiston, Elisabetta Lombardi, Stefania Zanolin, Alessandro Da Ponte, Giuseppe Astori, Cristina Durante, Mario Mazzucato

Abstract read
In one paragraph

Article in Journal of translational medicine, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 16 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
16citing papers in PubMed, 1 pooled it
–field-weighted citation impact
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

16 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
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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.

Francesco AgostiniStem Cell Unit, CRO Aviano National Cancer Institute, Aviano, PN, Italy.
Jerry PoleselUnit of Cancer Epidemiology, CRO Aviano National Cancer Institute, Aviano, PN, Italy.
Monica BattistonStem Cell Unit, CRO Aviano National Cancer Institute, Aviano, PN, Italy.
Elisabetta LombardiStem Cell Unit, CRO Aviano National Cancer Institute, Aviano, PN, Italy.
Stefania ZanolinStem Cell Unit, CRO Aviano National Cancer Institute, Aviano, PN, Italy.
Alessandro Da PonteStem Cell Unit, CRO Aviano National Cancer Institute, Aviano, PN, Italy.
Giuseppe AstoriAdvanced Cellular Therapy Laboratory, Department of Cellular Therapy and Hematology, San Bortolo Hospital, Vicenza, Italy.
Cristina DuranteStem Cell Unit, CRO Aviano National Cancer Institute, Aviano, PN, Italy.
Mario MazzucatoStem Cell Unit, CRO Aviano National Cancer Institute, Aviano, PN, Italy. mmazzucato@cro.it.ORCID 0000-0001-8319-053X

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundStandardized animal-free components are required for manufacturing cell-based medicinal products. Human platelet concentrates are sources of growth factors for cell expansion but such products are characterized by undesired variability. Pooling together single-donor products improves consistency, but the minimal pool sample size was never determined.

methodsSupernatant rich in growth factors (SRGF) derived from n = 44 single-donor platelet-apheresis was obtained by CaCl

resultsGrowth factor concentrations in single-donor SRGF were characterized by high variability (mean (pg/ml)-CV); VEGF: 950-81.4; FGF-b: 27-74.6; PDGF-AA: 7883-28.8; PDGF-AB: 107834-32.5; PDGF-BB: 11142-48.4; Endostatin: 305034-16.2; Angiostatin: 197284-32.9; TGF-β1: 68382-53.7; IGF-I: 70876-38.3; EGF: 2411-30.2). In silico performed analysis suggested that pooling n = 16 single-donor SRGF reduced CV below 20%. Concentrations measured in 10 pools of n = 16 single SRGF were not different from mean values measured in single SRGF, but the CV was reduced to or below the threshold. Separate SRGF pools failed to differently affect ASC growth rate (slope pool A = 0.6; R DISCUSSION: Results deriving from our algorithm and from validation utilizing real SRGF pools demonstrated that pooling n = 16 single-donor SRGF products can ameliorate variability of final growth factor concentrations. Different pools of n = 16 single donor SRGF displayed consitent capability to modulate growth and differentiation potential of expanded ASC. Increasing the pool size should not further improve product composition.

Indexed as

AlgorithmsBlood PlateletsCell- and Tissue-Based TherapyClinical Trials as TopicFemaleHumansIntercellular Signaling Peptides and ProteinsMiddle AgedPlatelet-Rich PlasmaReference StandardsIntercellular Signaling Peptides and ProteinsASC ex vivo expansionCell therapyGood manufacturing practiceGrowth factors from human plateletsMathematical algorithmReleasate standardization

Identifiers

PMID28526045
PMCPMC5437585

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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.