Expanded Access of Prochymal® (Ex-vivo Cultured Adult Human Mesenchymal Stem Cells) Infusion for the Treatment of Patients Who Have Failed to Respond to Steroid Treatment for Acute GVHD
- 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
- 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.