Study 275: Updated Expanded Access Program for Remestemcel-L in Steroid-Refractory Acute Graft-versus-Host Disease in Children.
Acute graft-versus-host disease
Allogeneic hematopoietic cell transplantation
Compassionate use
Mesenchymal stromal cell
Remestemcel-L
Steroid
Journal
Biology of blood and marrow transplantation : journal of the American Society for Blood and Marrow Transplantation
ISSN: 1523-6536
Titre abrégé: Biol Blood Marrow Transplant
Pays: United States
ID NLM: 9600628
Informations de publication
Date de publication:
05 2020
05 2020
Historique:
received:
20
11
2019
revised:
30
01
2020
accepted:
31
01
2020
pubmed:
12
2
2020
medline:
24
6
2021
entrez:
12
2
2020
Statut:
ppublish
Résumé
Clinical outcomes in children with steroid-refractory acute graft-versus-host disease (SR-aGVHD) are generally poor, with a high mortality rate and limited therapeutic options. Here we report our updated investigational experience with mesenchymal stromal cell (MSC) therapy with remestemcel-L in a multicenter expanded access protocol (ClinicalTrials.gov identifier NCT00759018) in 241 children with aGVHD who failed to respond to steroids with or without other secondary and tertiary immunosuppressive therapies. A total of 241 children with grade B-D SR-aGVHD were enrolled at 50 sites in 8 countries and received 8 biweekly i.v. infusions of human MSCs, 2 × 10
Identifiants
pubmed: 32044400
pii: S1083-8791(20)30059-8
doi: 10.1016/j.bbmt.2020.01.026
pmc: PMC8292970
mid: NIHMS1721330
pii:
doi:
Substances chimiques
Steroids
0
Banques de données
ClinicalTrials.gov
['NCT00759018']
Types de publication
Journal Article
Multicenter Study
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
855-864Subventions
Organisme : NCI NIH HHS
ID : P30 CA008748
Pays : United States
Informations de copyright
Copyright © 2020 American Society for Transplantation and Cellular Therapy. Published by Elsevier Inc. All rights reserved.
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