aGVHD

AcronymDefinition
aGVHDAcute Graft Versus Host Disease
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The successful outcome of the DSMB interim analysis using the trial's primary endpoint of Day 28 overall response is consistent with previously reported results in a pediatric Expanded Access Program (EAP) in children with steroid-refractory aGVHD.
The company plans to expand its use in adult patients with high-risk steroid-refractory aGVHD.
It is thought that both donor-derived alloreactive T cells similar to AGVHD and autoreactive T cell clones which can not be deleted as a result of thymic damage are involved (66, 67).
performed yet another study which sought to evaluate the use of ECP as second line therapy in patients with steroid-refractory aGvHD (50).
To support filing of a biologic license application to the FDA for regulatory approval, Mesoblast is conducting a 60-patient, open label Phase 3 trial using MSC-100-IV as front-line therapy in children with steroidrefractory aGvHD.
As to TRM and III-IV grade aGVHD, the incidences of patients treated with G-BM were significantly lower chance to develop aGVHD and greater chance of survival than those treated with SS-BM [Figure 2]a and b.
aGVHD of the liver develops within 2 to 10 weeks of alloHCT and occurs in approximately 40-60% of HLA-identical transplants [2,3,6,50,51].
ONTAK was well tolerated and demonstrated activity in treating steroid resistant aGVHD without an increase in relapse risk or unexpected infections.
To support filing of a biologic license application (BLA) to the FDA for regulatory approval, Mesoblast is conducting a 60-patient, open label Phase 3 trial using MSC -100-IVas front-line therapy in children with steroidrefractory aGvHD.
This large EAP data set continues to provide support for the benefit of MSC 100-IV for the treatment of aGVHD in children.