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

Completed · Phase 3 · Has a placebo group

Conditions studied: Graft Versus Host Disease

In brief

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

Key facts

Study ID

NCT00366145

Run by

Mesoblast, Inc.

People needed

260

Starts

2006-08-17

Expected to finish

2009-05-28

Last updated by the study team

2022-02-10

Who can join

Age: 1 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Participant must be 6 months to 70 years of age, inclusive.
• Participants 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.
• Participant 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.
• Participants 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.
• Participant must have adequate renal function as defined by: Calculated Creatinine Clearance of >30 milliliters per minute (mL/min) using the Cockcroft-Gault equation.
• For pediatric participants: Schwartz equation: (Participant population: infants over 1 week old through adolescence (<18 years old).
• Participants who are women of childbearing potential must be non-pregnant, not breast-feeding, and use adequate contraception. Male participants must use adequate contraception.
• Participant must have a minimum Karnofsky Performance Level of at least 30 at the time of study entry.
• Participant (or legal representative where appropriate) must be capable of providing written informed consent.

You may not qualify if…

• Participant has started treatment with second line therapy >24 hours prior to randomization.
• Participant has received agents other than steroids for primary treatment of acute GVHD.
• Participant is participating in the CTN Protocol 0302.
• Participant has any underlying or current medical or psychiatric condition that, in the opinion of the Investigator, would interfere with the evaluation of the participant including uncontrolled infection, heart failure, pulmonary hypertension, etc.
• Participant may not receive any other investigational agents (not approved by the FDA) concurrently during study participation or within 30 days of randomization.
• Participant has a known allergy to bovine or porcine products.
• Participant has received a transplant for a solid tumor disease.

Where it is running

• Arizona Cancer Center — Tucson, Arizona, United States
• City of Hope — Duarte, California, United States
• Univeristy of California San Francisco — San Francisco, California, United States
• Yale New Haven Hospital — New Haven, Connecticut, United States
• University of Miami — Miami, Florida, United States
• All Children's Hospital — St. Petersburg, Florida, United States
• Emory University — Atlanta, Georgia, United States
• Northside Hospital — Atlanta, Georgia, United States
• Northwestern Center for Clinical Research — Chicago, Illinois, United States
• Rush University Medical Center — Chicago, Illinois, United States
• University of Illinois - Chicago — Chicago, Illinois, United States
• Indiana Blood and Bone Marrow Transplant Center — Beech Grove, Indiana, United States
• Univeristy of Iowa Hospitals and Clinics — Iowa City, Iowa, United States
• University of Kansas Medical Center — Kansas City, Kansas, United States
• University of Louisville — Louisville, Kentucky, United States
• Louisiana State University — Shreveport, Louisiana, United States
• University of Maryland/Greenbaum — Baltimore, Maryland, United States
• Tufts-New England Medical Center — Boston, Massachusetts, United States
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
• Dana-Farber Cancer Institute — Boston, Massachusetts, United States
• Karmanos/Wayne State University — Detroit, Michigan, United States
• Mayo Clinic Rochester — Rochester, Minnesota, United States
• Univeristy of Mississippi Medical Center — Jackson, Mississippi, United States
• University of Nebraska — Omaha, Nebraska, United States
• University of Alabama at Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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