Trial Information

Summary: A Phase III, Randomized, Double Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Prochymal (Ex-Vivo Cultured Adult Human Mesenchymal Stem Cells) Infusion for the Treatment of Steroid-Refractory Acute GVHD (Protocol #280)

You have/Your child has been asked to participate in this research study because you have/your child has a diagnosis of acute (sudden and severe) graft versus host disease (GVHD) involving the intestines and/or skin and/or liver that has failed to respond to steroids after receiving an allogeneic donor (donated by another person) stem cell (immature cells that can become cells) transplant (ASCT) or donor leukocyte (white blood cell) infusion (DLI). The purpose of this study is to compare the experimental drug Prochymal to placebo (inactive substance) in terms of effectiveness and safety. Your/your child’s participation on this study is expected to last about 6 months, including 8 weeks of receiving Prochymal or placebo and follow-up afterwards.

Patient Inclusion/Exclusion Criteria:

- See http://clinicaltrials.coh.org for additional information.

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Trial listings updated: July 7, 2008 at 2:41:11 PM