Evidence map›Paper›PMID 34073206›Full record

ArticleCells2021

MSC Manufacturing for Academic Clinical Trials: From a Clinical-Grade to a Full GMP-Compliant Process.

Chantal Lechanteur, Alexandra Briquet, Virginie Bettonville, Etienne Baudoux, Yves Beguin

Abstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Cells, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 42 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
42citing 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

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

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  7. [Research advances in mesenchymal stem cell therapy for graft-versus-host disease].Zhonghua xue ye xue za zhi = Zhonghua xueyexue zazhi · 2026
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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

5 authors.

Chantal LechanteurLaboratory of Cell and Gene Therapy, Department of Hematology, CHU of Liège, 4000 Liège, Belgium.
Alexandra BriquetLaboratory of Cell and Gene Therapy, Department of Hematology, CHU of Liège, 4000 Liège, Belgium.
Virginie BettonvilleLaboratory of Cell and Gene Therapy, Department of Hematology, CHU of Liège, 4000 Liège, Belgium.
Etienne BaudouxLaboratory of Cell and Gene Therapy, Department of Hematology, CHU of Liège, 4000 Liège, Belgium.ORCID 0000-0002-1730-8357
Yves BeguinLaboratory of Cell and Gene Therapy, Department of Hematology, CHU of Liège, 4000 Liège, Belgium.ORCID 0000-0003-4650-7520

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Following European regulation 1394/2007, mesenchymal stromal cell (MSCs) have become an advanced therapy medicinal product (ATMP) that must be produced following the good manufacturing practice (GMP) standards. We describe the upgrade of our existing clinical-grade MSC manufacturing process to obtain GMP certification. Staff organization, premises/equipment qualification and monitoring, raw materials management, starting materials, technical manufacturing processes, quality controls, and the release, thawing and infusion were substantially reorganized. Numerous studies have been carried out to validate cultures and demonstrate the short-term stability of fresh or thawed products, as well their stability during long-term storage. Detailed results of media simulation tests, validation runs and early MSC batches are presented. We also report the validation of a new variant of the process aiming to prepare fresh MSCs for the treatment of specific lesions of Crohn's disease by local injection. In conclusion, we have successfully ensured the adaptation of our clinical-grade MSC production process to the GMP requirements. The GMP manufacturing of MSC products is feasible in the academic setting for a limited number of batches with a significant cost increase, but moving to large-scale production necessary for phase III trials would require the involvement of industrial partners.

Indexed as

Cell Culture TechniquesCell DifferentiationCell ProliferationCell SurvivalClinical Trials as TopicCulture MediaHumansMesenchymal Stem CellsQuality ControlCulture MediaATMP manufacturingcell therapyGMPmesenchymal stromal cellsMSC

Identifiers

PMID34073206
PMCPMC8227789

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.