Prochymal Expanded Access Treatment for Pediatric Patients Who Have Failed Steroids for Acute GVHD

NO_LONGER_AVAILABLE

Conditions studied: Graft vs Host Disease, Graft-Versus-Host Disease

In brief

This protocol allows for the treatment of pediatric patients, male and female, between the ages of 2 months and 17 years. Patients must have failed steroid treatment for Grade B-D acute GVHD.

Key facts

Study ID

NCT00759018

Run by

Mesoblast, Inc.

Last updated by the study team

2020-03-09

Who can join

Age: 0 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients must sign an informed consent form (ICF) before any protocol-related procedures, including any pre-treatment procedures, are performed.
• Since patients being treated with Prochymal® under this protocol are under 18, a parental signature of informed consent will be required.
• Patients must be 2 months to 17 years of age, inclusive.
• Patients must have failed to respond to steroid treatment for Grades B-D acute GVHD • Failure to respond to steroid treatment for acute GVHD is defined as any Grade B-D acute GVHD that is not improving after at least 3 days of methylprednisolone (≥1 milligram per kilogram per day [mg/kg/day]) or equivalent.

You may not qualify if…

• Patient must not have a known allergy to bovine or porcine products.
• Patient must not have received a transplant for a solid tumor disease.
• Patients must not have evidence of a pulmonary infiltrate or diffuse alveolar hemorrhage and must be unlikely to require more than 2 liters (L) of oxygen via face mask or an estimated fraction of inspired oxygen (FiO2) of 28% via other delivery methods in order to sustain an O2 saturation of 92% during the next 3 days.

Where it is running

• Phoenix Children's Hospital — Phoenix, Arizona, United States
• Children's Hospital of Orange County — Orange, California, United States
• UCSF — San Francisco, California, United States
• Children's National — Washington D.C., District of Columbia, United States
• Nemours Children's Clinic — Jacksonville, Florida, United States
• University of Miami — Miami, Florida, United States
• Childrens Memorial — Chicago, Illinois, United States
• James Witcomb Riley Hosptial for Children — Indianapolis, Indiana, United States
• LSU Health Science Center/Children's Hospital — New Orleans, Louisiana, United States
• Wayne State University/Childrens' Hospital — Detroit, Michigan, United States
• Children's Mercy Hospital — Kansas City, Missouri, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• Hackensack University Medical Center — Hackensack, New Jersey, United States
• Columbia Medical Center — New York, New York, United States
• Memorial Sloan-Kettering Cancer Center — New York, New York, United States
• Levine Children's Hospital — Charlotte, North Carolina, United States
• Duke University Medical Center — Durham, North Carolina, United States
• Doernbecher Children's Hospital (OHSU) — Portland, Oregon, United States
• Medical University of South Carolina — Charleston, South Carolina, United States
• Vanderbilt Children's Hospital — Nashville, Tennessee, United States
• Texas Childrens Hospital — Houston, Texas, United States
• Methodist Childrens Hospital of South Texas — San Antonio, Texas, United States
• Massey Cancer Center — Richmond, Virginia, United States
• Medical College of Wisconsin — Milwaukee, Wisconsin, United States
• Alberta Children's Hospital — Calgary, Alberta, Canada

Full record on ClinicalTrials.gov

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