Evidence map›Paper›PMID 27207011›Full record

ArticleJournal of translational medicine2016

Clinical-scale expansion of mesenchymal stromal cells: a large banking experience.

Chantal Lechanteur, Alexandra Briquet, Olivier Giet, Olivier Delloye, Etienne Baudoux, Yves Beguin

Open access · goldAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Journal of translational medicine, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 75 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
75citing papers in PubMed, 1 pooled it
10.7field-weighted citation impact, top 1% 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

75 citing papers in PubMed, 1 synthesis or guideline pooled it, 160 citations in OpenAlex.

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15 more citing papers are in PubMed but not listed here.

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

6 authors at 1 institution in 1 country.

Chantal LechanteurDepartment of Hematology, Laboratory of Cell and Gene Therapy, CHU of Liège and University of Liège, CHU Sart-Tilman, 4000, Liège, Belgium. c.lechanteur@chu.ulg.ac.be.
Alexandra BriquetDepartment of Hematology, Laboratory of Cell and Gene Therapy, CHU of Liège and University of Liège, CHU Sart-Tilman, 4000, Liège, Belgium.
Olivier GietDepartment of Hematology, Laboratory of Cell and Gene Therapy, CHU of Liège and University of Liège, CHU Sart-Tilman, 4000, Liège, Belgium.
Olivier DelloyeDepartment of Hematology, Laboratory of Cell and Gene Therapy, CHU of Liège and University of Liège, CHU Sart-Tilman, 4000, Liège, Belgium.
Etienne BaudouxDepartment of Hematology, Laboratory of Cell and Gene Therapy, CHU of Liège and University of Liège, CHU Sart-Tilman, 4000, Liège, Belgium.
Yves BeguinDepartment of Hematology, Laboratory of Cell and Gene Therapy, CHU of Liège and University of Liège, CHU Sart-Tilman, 4000, Liège, Belgium.
University of Liège · BE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundMesenchymal stromal cells (MSC) are largely investigated in clinical trials aiming to control inappropriate immune reactions (GVHD, Crohn's disease, solid organ transplantation). As the percentage of MSC precursors in bone marrow is very low, these must be expanded in vitro to obtain therapeutic cell doses. We describe here the constitution of an allogeneic human third-party MSC bank from screened healthy volunteer donors in compliance with quality specifications and ISCT-release criteria and report follow-up of different aspects of this activity since 2007.

methods68 clinical-grade large-scale MSC cultures were completed and analyzed. The whole process was described, including volunteer donor screening, bone marrow collection, mononuclear cell isolation and expansion over 4 weeks, harvesting, cryopreservation, release, administration and quality controls of the cells (including microbiology, phenotype, and potency assays).

resultsFrom 59 validated donors, 68 cultures were completed (mean of final yields: 886 × 10(6) cells/culture) and a total of 464 MSC aliquots have been produced and stored in liquid nitrogen (mean of 132.8 × 10(6) cells/bag). Each MSC batch underwent extensive testing to verify its conformity with EBMT and ISCT release criteria and was individually validated. As of June 1 2015, 314 bags have been released and infused to patients included in 6 different clinical protocols. All thawed MSC units satisfied to release criteria and no infusion-related toxicity was reported.

conclusionIn conclusion, despite low passage cultures, we have been able to create an allogeneic "off-the-shelf" MSC bank with a large number of frozen aliquots and report here an efficient clinical-grade MSC banking activity in place for more than 7 years. Our challenge now is to produce MSC in compliance with good manufacturing practices (GMP) as, in the meantime, MSC have become considered as advanced therapy medicinal products (ATMP). Another significant challenge remains the development of relevant potency assay.

Indexed as

Tissue BanksCell Culture TechniquesCell ProliferationCells, CulturedCell SurvivalCryopreservationGuideline AdherenceHumansImmunosuppression TherapyMesenchymal Stem CellsQuality ControlReproducibility of ResultsBankingClinical-gradeGMPMesenchymal stem cellsMSC

Identifiers

PMID27207011
PMCPMC4875672
OpenAlexW2395292627

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.