Evidence map›Paper›PMID 30355298›Full record

ArticleJournal of translational medicine2018

Stability enhancement of clinical grade multipotent mesenchymal stromal cell-based products.

Clémentine Mirabel, Eduard Puente-Massaguer, Anna Del Mazo-Barbara, Blanca Reyes, Philip Morton, Francesc Gòdia, Joaquim Vives

Abstract read
In one paragraph

Article in Journal of translational medicine, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 20 papers.

0numbers the graph read from it
0cells of the map it votes in
20citing papers in PubMed
–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

20 citing papers in PubMed.

  1. Review
  2. Article
  3. Article
  4. Article
  5. Article
  6. Review
  7. Illustrative Potency Assay Examples from Approved Therapies.Advances in experimental medicine and biology · 2023
    Article
  8. Review
  9. Review
  10. Article
  11. Article
  12. Review
  13. Article
  14. Review
  15. Article
  16. Article
  17. Article
  18. Article
  19. Review
  20. Article
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

7 authors.

Clémentine MirabelServei de Teràpia Cellular, Banc de Sang i Teixits, Edifici Dr. Frederic Duran i Jordà, Passeig Taulat, 116, 08005, Barcelona, Spain.
Eduard Puente-MassaguerDepartament d'Enginyeria Química, Biològica i Ambiental Escola d'Enginyeria, Universitat Autònoma de Barcelona, 08193, Bellaterra, Cerdanyola del Vallès, Spain.
Anna Del Mazo-BarbaraServei de Teràpia Cellular, Banc de Sang i Teixits, Edifici Dr. Frederic Duran i Jordà, Passeig Taulat, 116, 08005, Barcelona, Spain.
Blanca ReyesServei de Teràpia Cellular, Banc de Sang i Teixits, Edifici Dr. Frederic Duran i Jordà, Passeig Taulat, 116, 08005, Barcelona, Spain.
Philip MortonAlbumedix Ltd, 59 Castle Boulevard, Nottingham, NG7 1FD, UK.
Francesc GòdiaDepartament d'Enginyeria Química, Biològica i Ambiental Escola d'Enginyeria, Universitat Autònoma de Barcelona, 08193, Bellaterra, Cerdanyola del Vallès, Spain. Francesc.Godia@uab.cat.
Joaquim VivesServei de Teràpia Cellular, Banc de Sang i Teixits, Edifici Dr. Frederic Duran i Jordà, Passeig Taulat, 116, 08005, Barcelona, Spain. jvives@bst.cat.ORCID 0000-0001-9719-5235

Funding

Agència de Gestió d'Ajuts Universitaris i de Recerca 2017SGR898Generalitat de Catalunya 2017SGR719Instituto de Salud Carlos III RD16/0011/0028
6 · The paper itself

Abstract

backgroundSuccessful delivery of cell-based therapeutics into patients is compromised by their short shelf-life upon release from production facilities due to the living nature of the active component that rapidly loses viability, and therefore its properties. In this context, the use of appropriate additives may contribute to the stabilisation of the cellular component within specifications for a longer time until administration.

resultsIn the present study, we evaluated the effect of different formulations on the stability of viability, identity, and potency of clinical grade multipotent mesenchymal stromal cells in suspension, both electrolyte solution and protein content were found to impact on their shelf-life. Particularly cryopreservation of cells in a Plasmalyte 148 supplemented with 2% (w/v) AlbIX (a yeast-derived recombinant albumin) and 10% (v/v) dimethyl sulfoxide, and final formulation post-thawing in Plasmalyte 148 supplemented with 2% (w/v) AlbIX enabling prolonged stability from 24 h up to 72 h in optimal conditions. Further investigation on the mechanisms of action involved revealed a delay of apoptosis progression into late stage when AlbIX was present.

conclusionsThe use of optimal formulations for each cell type of interest is crucial to extend the shelf life of cell-based pharmaceuticals and contribute to solve logistical challenges. We demonstrated that the use of Plasmalyte 148 supplemented with 2% (w/v) AlbIX resulted in superior stability of multipotent mesenchymal stromal cells without affecting their identity and multipotency.

Indexed as

ApoptosisBone Marrow CellsCell SurvivalCryopreservationCryoprotective AgentsElectrolytesHumansMesenchymal Stem CellsMultipotent Stem CellsPhenotypeSerum Albumin, HumanSolutionsStromal CellsCryoprotective AgentsElectrolytesSerum Albumin, HumanSolutionsApoptosisCell cultureCellular therapyLogisticsMultipotent mesenchymal stromal cellPotency assayQuality complianceStability assessment

Identifiers

PMID30355298
PMCPMC6201632

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.