Ex vivo-expanded highly pure ABCB5
ABCB5
GMP manufacturing
advanced therapy medicinal product
chronic wound
mesenchymal stromal cells
venous ulcer
Journal
Cytotherapy
ISSN: 1477-2566
Titre abrégé: Cytotherapy
Pays: England
ID NLM: 100895309
Informations de publication
Date de publication:
02 2021
02 2021
Historique:
received:
14
05
2020
revised:
05
08
2020
accepted:
29
08
2020
pubmed:
5
10
2020
medline:
7
10
2021
entrez:
4
10
2020
Statut:
ppublish
Résumé
Mesenchymal stromal cells (MSCs) hold promise for the treatment of tissue damage and injury. However, MSCs comprise multiple subpopulations with diverse properties, which could explain inconsistent therapeutic outcomes seen among therapeutic attempts. Recently, the adenosine triphosphate-binding cassette transporter ABCB5 has been shown to identify a novel dermal immunomodulatory MSC subpopulation. The authors have established a validated Good Manufacturing Practice (GMP)-compliant expansion and manufacturing process by which ABCB5 As of now, 12 wounds in nine patients have been treated with 5 × 10 The authors describe here their GMP- and European Pharmacopoeia-compliant production and quality control process, report on a pre-clinical dose selection study and present the first in-human results. Together, these data substantiate the idea that ABCB5
Sections du résumé
BACKGROUND AIM
Mesenchymal stromal cells (MSCs) hold promise for the treatment of tissue damage and injury. However, MSCs comprise multiple subpopulations with diverse properties, which could explain inconsistent therapeutic outcomes seen among therapeutic attempts. Recently, the adenosine triphosphate-binding cassette transporter ABCB5 has been shown to identify a novel dermal immunomodulatory MSC subpopulation.
METHODS
The authors have established a validated Good Manufacturing Practice (GMP)-compliant expansion and manufacturing process by which ABCB5
RESULTS
As of now, 12 wounds in nine patients have been treated with 5 × 10
CONCLUSIONS
The authors describe here their GMP- and European Pharmacopoeia-compliant production and quality control process, report on a pre-clinical dose selection study and present the first in-human results. Together, these data substantiate the idea that ABCB5
Identifiants
pubmed: 33011075
pii: S1465-3249(20)30851-3
doi: 10.1016/j.jcyt.2020.08.012
pmc: PMC8310651
mid: NIHMS1714686
pii:
doi:
Substances chimiques
ABCB5 protein, human
0
ATP Binding Cassette Transporter, Subfamily B
0
Banques de données
ClinicalTrials.gov
['NCT03257098', 'NCT03267784', 'NCT03529877', 'NCT03860155']
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
165-175Subventions
Organisme : BLRD VA
ID : I01 BX000516
Pays : United States
Organisme : RRD VA
ID : I01 RX000989
Pays : United States
Organisme : NEI NIH HHS
ID : R01 EY025794
Pays : United States
Organisme : NEI NIH HHS
ID : R24 EY028767
Pays : United States
Informations de copyright
Copyright © 2020 International Society for Cell & Gene Therapy. Published by Elsevier Inc. All rights reserved.
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