Efficacy and Safety of Adult Human Mesenchymal Stem Cells to Treat Steroid Refractory Acute Graft Versus Host Disease

• Status: Completed
• Trial end date: 2009-05-28
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the efficacy and gather additional safety of Prochymal in subjects who have failed to respond to steroid treatment of Grades B-D acute GVHD.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mesoblast, Inc.
• Treatments: Remestemcel-l

Criteria

Inclusion Criteria:

• Subjects must be 6 months to 70 years of age, inclusive

• Subjects who have failed to respond to steroid treatment:

Failure to respond to steroid treatment is defined as any grade B-D (IBMTR grading) of acute GVHD that shows:

No improvement after 3 days and a duration of no greater than 2 weeks while receiving treatment with Methylprednisolone (greater than or equal to 1 mg/kg/day) or equivalent.

• Subjects must be treated within 4 days of randomization . In urgent situations 2nd line therapy may be started 24 hours prior to randomization , and Prochymal must be initiated within the following 3 days.

• Subjects who have received an increase in their steroid dose treatment prior to randomization will be eligible for enrollment. An increase in steroid dose will not be considered as second line therapy.

• Subjects must have adequate renal function as defined by: Calculated Creatinine Clearance of >30 mL/min using the Cockcroft-Gault equation

• For pediatric patients: Schwartz equation: (Patient population: infants over 1 week old through adolescence (<18 years old)

• Subjects who are women of childbearing potential, must be non-pregnant, not breast-feeding, and use adequate contraception. Male subjects must use adequate contraception

• Subject must have a minimum Karnofsky Performance Level of at least 30 at the time of study entry

• Subject (or legal representative where appropriate) must be capable of providing written informed consent.

Exclusion Criteria:

• Subject has started treatment with second line therapy >24 hours prior to randomization.

• Subject has received agents other than steroids for primary treatment of acute GVHD

• Subject is participating in the CTN Protocol 0302

• 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 including uncontrolled infection, heart failure, pulmonary hypertension, etc.

• Subjects may not receive any other investigational agents (not approved by the FDA) concurrently during study participation or within 30 days of randomization.

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

• Subject has received a transplant for a solid tumor disease.