Pooled human bone marrow-derived mesenchymal stromal cells with defined trophic factors cargo promote dermal wound healing in diabetic rats by improved vascularization and dynamic recruitment of M2-like macrophages.
chronic wound healing
clinical scale production
efficacy
mesenchymal stromal cells (MSCs)
pathogen-inactivation
platelet lysate
pooling
potency
Journal
Frontiers in immunology
ISSN: 1664-3224
Titre abrégé: Front Immunol
Pays: Switzerland
ID NLM: 101560960
Informations de publication
Date de publication:
2022
2022
Historique:
received:
23
06
2022
accepted:
27
07
2022
entrez:
5
9
2022
pubmed:
6
9
2022
medline:
9
9
2022
Statut:
epublish
Résumé
Human Mesenchymal Stromal Cells (hMSCs) are a promising source for cell-based therapies. Yet, transition to phase III and IV clinical trials is remarkably slow. To mitigate donor variabilities and to obtain robust and valid clinical data, we aimed first to develop a manufacturing concept balancing large-scale production of pooled hMSCs in a minimal expansion period, and second to test them for key manufacture and efficacy indicators in the clinically highly relevant indication wound healing. Our novel clinical-scale manufacturing concept is comprised of six single donor hMSCs master cell banks that are pooled to a working cell bank from which an extrapolated number of 70,000 clinical doses of 1x10
Identifiants
pubmed: 36059533
doi: 10.3389/fimmu.2022.976511
pmc: PMC9437960
doi:
Types de publication
Journal Article
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
976511Informations de copyright
Copyright © 2022 Willer, Spohn, Morgenroth, Thielemann, Elvers-Hornung, Bugert, Delorme, Giesen, Schmitz-Rixen, Seifried, Pfarrer, Schäfer and Bieback.
Déclaration de conflit d'intérêts
BD and MG are employees of Macopharma. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest. The authors declare that this study received funding from Macopharma. The funder had the following involvement in the study: provision of funding and material; manuscript writing and review of the final manuscript. Macopharma also provided high-dose gamma irradiated pooled hPL.
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