Prochymal Expanded Access Treatment for Pediatric Patients Who Have Failed Steroids for Acute GVHD
- Conditions
- Graft-Versus-Host DiseaseGraft vs Host Disease
- Registration Number
- NCT00759018
- Lead Sponsor
- Mesoblast, Inc.
- Brief Summary
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.
- Detailed Description
For the treatment of pediatric patients who have failed to respond to steroid treatment for acute graft-versus-host disease (GVHD). Failing steroid treatment for acute GVHD is defined as any Grade B-D (IBMTR grading) of acute GVHD that is not improving after at least 3 days of methylprednisolone (≥ 1 mg/kg/day) or equivalent.
Patients will be treated with Prochymal twice per week at a dose of 2 x 10\^6 hematopoietic stem cells (hMSC)/kg (actual body weight) for each of 4 consecutive weeks. Infusions will be administered at least 3 days apart.
Recruitment & Eligibility
- Status
- NO_LONGER_AVAILABLE
- Sex
- All
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- EXPANDED_ACCESS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (27)
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, 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
Scroll for more (17 remaining)Phoenix Children's Hospital🇺🇸Phoenix, Arizona, United States