Efficacy and Safety of Prochymal® Infusion in Combination With Corticosteroids for the Treatment of Newly Diagnosed Acute Graft Versus Host Disease (GVHD)

Inclusion Criteria

• •Participants must be 18 years to 70 years of age, inclusive
• •Participants must have received an allogeneic hematopoietic stem cell transplant using either bone marrow, peripheral blood stem cells or cord blood or administered a donor leukocyte infusion.
• •Participants must have newly diagnosed Grades B-D acute GVHD. Biopsy confirmation of GVHD is strongly recommended but not required. Randomization should not be delayed awaiting biopsy or pathology results.
• •Participants must be randomized and treated with corticosteroid (1-2 mg/kg/d methylprednisolone, or equivalent) and Prochymal®/placebo within 72 hours of onset of acute GVHD.
• •Participants must have adequate renal function as defined by: Calculated Creatinine Clearance of \>30 mL/min using the Cockcroft-Gault equation
• •Participants who are women of childbearing potential, must be non-pregnant, not breast-feeding, and use adequate contraception. Male participants must use adequate contraception
• •Participant must have a minimum Karnofsky Performance Level of at least 30 at the time of study entry
• •Participant (or legal representative where appropriate) must be capable of providing written informed consent.