Prochymal® Expanded Access for Adults Who Have Failed Steroid Treatment for Acute Graft Versus Host Disease (GVHD)

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 2 liters of oxygen via face mask or an estimated fractional inspired oxygen concentration (FiO2) of 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.