Prochymal® Expanded Access for Adults Who Have Failed Steroid Treatment for Acute GVHD

Inclusion Criteria:

• Patients must be 18 years to 70 years of age, inclusive.
• Biopsy confirmation of GVHD is strongly recommended, to exclude patients presenting with diarrhea or abnormal liver function tests caused by infection.
• Patients must have failed to respond to steroid treatment (methylprednisolone [≥1mg/kg/day] or equivalent) for Grades C-D acute GVHD.
• Prochymal must be administered not longer than 14 days after the initiation of systemic steroid therapy for acute GVHD.
• Prochymal must be administered either before or at the same time any additional GVHD therapy is administered
• Patients must have an adequate renal function as defined by Cockroft-Gault equation:Calculated creatinine clearance (CrCl) > 30mL/min
• Patients who are women of childbearing potential, must be non-pregnant, not breast-feeding, and use adequate contraception. Male patients must use adequate contraception.

Exclusion Criteria:

• Patient has stage 3 or 4 liver GVHD, bilirubin >6 mg/dl.
• Patient has stage 4 GI-GVHD.
• Patient has any underlying or current medical condition that would interfere with the evaluation of the patient including uncontrolled infection, sepsis, organ failure, etc or any medical condition that has a high probability of causing death in less than 30 days.
• Patient may not receive any other investigational agent (not approved by the FDA for any indication) concurrently for the duration of the protocol.
• Patient has evidence of a pulmonary infiltrate or diffuse alveolar hemorrhage and must not be likely to require more than 2L of oxygen via face mask or an estimated FiO2of 28% via other delivery methods in order to sustain an O2 saturation of 92% during the next 3 days.
• Patient has a known allergy to bovine or porcine products
• Patient has a medical history of a solid tumor disease.