Safety and Efficacy Study of Adult Human Mesenchymal Stem Cells to Treat Acute Graft Versus Host Disease (GVHD)

• Status: Completed
• Trial end date: 2008-07-14
• Target enrollment: 0
• Participant gender: All

Summary

To establish the safety and efficacy of two dose levels of Ex-vivo Cultured Adult HumanMesenchymal Stem Cells (Prochymal) in subjects experiencing acute GVHD, Grades II-IV, post hematopoietic stem cells (HSC) transplant.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mesoblast, Inc.; Osiris Therapeutics
• Treatments: Methylprednisolone; Remestemcel-l

Criteria

Protocol 260 Inclusion Criteria:

• Subjects must be 18 to 70 years of age inclusive

• If female and of child-bearing age, subjects must be non-pregnant, not breast feeding, and use adequate contraception. Males must use adequate contraception.

• Subject must have newly diagnosed, Grade II-IV acute GVHD requiring therapy. Biopsy for confirmation of GVHD is not mandatory, but is recommended when feasible. Enrollment should not be delayed awaiting biopsy results.

• Subject must have received either full or reduced intensity myeloablative regimens followed by an allogeneic hematopoietic stem cell transplant using bone marrow, peripheral blood stem cell, or cord blood, including donor lymphocyte infusion (DLI)

• Subjects must have minimal renal and hepatic function as defined by:

• Calculated creatinine clearance (CLcr) of > 30 mL/min using the Cockroft-Gault equation

• Subject must be available for all specified assessments at the study site through study Day 28.

• Subjects must provide written informed consent and authorization for use and disclosure of protected health information (PHI).

Protocol 260 Exclusion Criteria:

• Subject has received previous treatment for Grade II-IV acute GVHD (except as noted in criterion 2).

• Subject has been treated for GVHD with methylprednisolone, > 2mg/kg/day, for more than 72 hours prior to receiving Prochymal™

• Subject has uncontrolled alcohol or substance abuse within 6 months of randomization.

• Subject has received an investigational agent (not approved by FDA for marketed use in any indication) within 30 days of randomization. Subjects may not receive an investigational agent during the 28-day study period

• 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 unstable arrhythmia

• Subject is unwilling to sign consent form for the long-term follow-up study, protocol No. 261

• Subject has a known allergy to bovine or porcine products.

• Subject had received transplant for a solid tumor disease.