aGVHDAcute Graft Versus Host Disease
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Infusion of IL-22Ab Markedly Suppressed Donor Cell Engraftment and Prevented the Disease-Associated Depletion of Host Cells in aGVHD Mice.
HLA loci have also been reported to have impacts on acute graft-versus-host disease (aGVHD),[sup][13],[14],[15],[16],[17],[18],[19],[20],[21],[22],[23],[24] which is a major complication of allogeneic hematopoietic stem cell transplantation (allo-HSCT).
Australia-based Mesoblast's intravenous product candidate, MSC-100-IV, has been successful in a pre-specified interim futility analysis in the phase three trial of the product that was used as front-line therapy in children with steroid-resistant acute graft versus host disease (aGVHD), it was reported yesterday.
The endpoints of this study were engraftment, aGVHD and cGVHD, infectious complications, non-relapse mortality (NRM), relapse rate, disease-free survival (DFS), and overall survival (OS).
IL-17A and IL-17F Levels in Blood and Saliva and the Incidence of aGVHD. No association was found between IL17A or IL-17F levels in the blood or saliva samples and the occurrence of systemic cGVHD (data not shown).
Liver biopsy is not particularly helpful in establishing a drug-induced hepatotoxicity, but is important in excluding other causes of liver disease such as SOS, aGVHD and sepsis.
The company plans to broaden its use in adult patients with high-risk steroid-refractory aGVHD.
Several studies on myeloablative conditioning allogeneic transplantation have shown that low whole blood concentrations of CsA during the periengraftment period can strongly affect the incidence of grade 2-4 acute GVHD (aGVHD) [5, 6].
Mesoblast initiated a rolling Biologics License Application (BLA) with the United States Food and Drug Administration (FDA) for remestemcel-L in the treatment of pediatric aGVHD; in preparation for product launch, focus is on inventory and commercial team ramp up.
Mesoblast plans to file for United States FDA regulatory approval of remestemcel-L shortly for the treatment of aGVHD.
Proceeds will be primarily used towards funding the commercialization of MSC-100-IV (remestemcel-L) after this product candidate successfully met its Phase 3 trial's primary endpoint of Day 28 overall response in children with steroid refractory acute Graft versus Host Disease (aGVHD).