Evidence map›Paper›PMID 37629136›Full record

ArticleInternational journal of molecular sciences2023

Quality Control Optimization for Minimizing Security Risks Associated with Mesenchymal Stromal Cell-Based Product Development.

Carmen Lúcia Kuniyoshi Rebelatto, Lidiane Maria Boldrini-Leite, Debora Regina Daga, Daniela Boscaro Marsaro, Isadora May Vaz, Valderez Ravaglio Jamur, Alessandra Melo de Aguiar, Thalita Bastida Vieira, Bianca Polak Furman, Cecília Oliveira Aguiar and 1 more

Open access · goldAbstract read
In one paragraph

Article in International journal of molecular sciences, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 18 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
18citing papers in PubMed, 1 pooled it
4.9field-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

18 citing papers in PubMed, 1 synthesis or guideline pooled it, 17 citations in OpenAlex.

  1. Pooled it
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  14. Biomedical Application of MSCs in Corneal Regeneration and Repair.International journal of molecular sciences · 2025
    Review
  15. Mesenchymal stromal cells forFrontiers in microbiology · 2025
    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

11 authors at 2 institutions in 1 country.

Carmen Lúcia Kuniyoshi RebelattoCore for Cell Technology, School of Medicine, Pontifícia Universidade Católica do Paraná, Curitiba 80215-901, Brazil.ORCID 0000-0003-1407-0416
Lidiane Maria Boldrini-LeiteCore for Cell Technology, School of Medicine, Pontifícia Universidade Católica do Paraná, Curitiba 80215-901, Brazil.
Debora Regina DagaCore for Cell Technology, School of Medicine, Pontifícia Universidade Católica do Paraná, Curitiba 80215-901, Brazil.
Daniela Boscaro MarsaroCore for Cell Technology, School of Medicine, Pontifícia Universidade Católica do Paraná, Curitiba 80215-901, Brazil.
Isadora May VazCore for Cell Technology, School of Medicine, Pontifícia Universidade Católica do Paraná, Curitiba 80215-901, Brazil.
Valderez Ravaglio JamurCore for Cell Technology, School of Medicine, Pontifícia Universidade Católica do Paraná, Curitiba 80215-901, Brazil.
Alessandra Melo de AguiarLaboratory of Basic Biology of Stem Cells, Carlos Chagas Institute-Fiocruz-Paraná, Curitiba 81350-010, Brazil.ORCID 0000-0002-6167-8478
Thalita Bastida VieiraCore for Cell Technology, School of Medicine, Pontifícia Universidade Católica do Paraná, Curitiba 80215-901, Brazil.ORCID 0000-0001-8831-2911
Bianca Polak FurmanCore for Cell Technology, School of Medicine, Pontifícia Universidade Católica do Paraná, Curitiba 80215-901, Brazil.ORCID 0009-0007-2585-9531
Cecília Oliveira AguiarCore for Cell Technology, School of Medicine, Pontifícia Universidade Católica do Paraná, Curitiba 80215-901, Brazil.
Paulo Roberto Slud BrofmanCore for Cell Technology, School of Medicine, Pontifícia Universidade Católica do Paraná, Curitiba 80215-901, Brazil.ORCID 0000-0001-6401-782X
Pontifícia Universidade Católica do Paraná · BRFundação Carlos Chagas · BR

Funding

National Council for Scientific and Technological Development 403624/2020-7
6 · The paper itself

Abstract

Mesenchymal stromal cells (MSCs) have been considered a therapeutic strategy in regenerative medicine because of their regenerative and immunomodulatory properties. The translation of MSC-based products has some challenges, such as regulatory and scientific issues. Quality control should be standardized and optimized to guarantee the reproducibility, safety, and efficacy of MSC-based products to be administered to patients. The aim of this study was to develop MSC-based products for use in clinical practice. Quality control assays include cell characterization, cell viability, immunogenicity, and cell differentiation; safety tests such as procoagulant tissue factor (TF), microbiological, mycoplasma, endotoxin, genomic stability, and tumorigenicity tests; and potency tests. The results confirm that the cells express MSC markers; an average cell viability of 96.9%; a low expression of HLA-DR and costimulatory molecules; differentiation potential; a high expression of TF/CD142; an absence of pathogenic microorganisms; negative endotoxins; an absence of chromosomal abnormalities; an absence of genotoxicity and tumorigenicity; and T-lymphocyte proliferation inhibition potential. This study shows the relevance of standardizing the manufacturing process and quality controls to reduce variability due to the heterogeneity between donors. The results might also be useful for the implementation and optimization of new analytical techniques and automated methods to improve safety, which are the major concerns related to MSC-based therapy.

Indexed as

Biological AssayMesenchymal Stem CellsCarcinogenicity TestsEndotoxinsHumansQuality ControlReproducibility of ResultsEndotoxinsadvanced therapy medicinal productgood manufacturing practiceumbilical cord

Identifiers

PMID37629136
PMCPMC10455270
OpenAlexW4386029041

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.