Abstract
Severe acute graft vs. host disease (GVHD) unresponsive to steroid and other immunosuppressive therapy typically leads to poor outcomes and high mortality. Case reports of human mesenchymal stem cells (MSCs) used for the rescue of pediatric patients with severe GVHD resistant to multiple second line agents has generated interest in the therapy because of its potential efficacy and encouraging safety profile. In this study we evaluate the risk/benefit profile of MSCs (Prochymal®) administered under an FDA Expanded Access Program (Protocol 275) as a rescue agent for treatment resistant GVHD in pediatric patients.
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