Safety and Efficacy of Prochymal for the Salvage of Treatment-Refractory Acute GVHD Patients
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This study is designed to evaluate the safety and efficacy of Prochymal(TM) (Ex-vivo Cultured Adult Human Mesenchymal Stem Cells) in subjects experiencing treatment-refractory acute GVHD, Grades III-IV, that is refractory to standard first line therapies and at least one second-line therapy.
Condition or disease
Graft Versus Host Disease
Drug: Prochymal (TM)
Allogeneic hematopoetic stem cell transplantation (HCT) is used in the treatment of a variety of hematological, myeloproliferative and lymphoproliferative disorders, and malignancies involving solid tumors. Patients receiving HCT can develop a life threatening condition called graft versus host disease (GVHD). GVHD occurs when donor T cells from the donor bone marrow recognize host cells as "foreign" and initiate an inflammatory immunological response. The standard of care for treatment of acute GVHD consists of intravenous delivery of methylprednisolone starting on day 1 and continuation of either cyclosporine or tacrolimus. This regimen of steroids and immunosuppressive drugs may relieve symptoms of GVHD, but some patients are refractory to current standard of care treatment. For treatment-refractory patients with grades III-IV GVHD mortality is approximately 80%. A therapy that could effectively suppress the immunological response from GVHD and help repair the damaged tissue could significantly decrease the mortality rate from this disease.
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Ages Eligible for Study:
6 Months to 70 Years (Child, Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Subjects must be 6 months to 70 years of age inclusive.
If female and of childbearing age, subjects must be non-pregnant, not breast-feeding, and use adequate contraception. Male subjects must use adequate contraception.
Subjects must have Grade III-IV acute GVHD that has failed to respond to standard first and at least one second-line therapy. Biopsy for confirmation of both skin and gastrointestinal GVHD is not mandatory, but is recommended when feasible. Enrollment should not be delayed awaiting biopsy results.
Subjects must have minimal renal function as defined by:Calculated CrCl of > 30 mL/min using the Cockroft Gault equation.
Subject must provide written informed consent and authorization for use and disclosure of PHI.
Subject has uncontrolled alcohol or substance abuse within 6 months of treatment.
Subject has any underlying or current medical or psychiatric condition that, in the opinion of the Investigator, would interfere with the evaluation of the subject (e.g., uncontrolled infection, right heart failure, pulmonary hypertension, etc.).
Subject has a clinically significant, unstable arrhythmia.
Subject has a known allergy to bovine or porcine products.
Subject is unwilling to sign consent form for the long-term follow-up study, protocol No. 271