Prochymal Expanded Access Treatment for Pediatric Patients Who Have Failed Steroids for Acute GVHD
Expanded Access of Prochymal (Ex-vivo Cultured Adult Human Mesenchymal Stem Cells) Infusion for the Treatment of Pediatric Patients Who Have Failed to Respond to Steroid Treatment for Acute GVHD
1 other identifier
expanded_access
N/A
2 countries
27
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.
Trial Health
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27 active sites
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 23, 2008
CompletedFirst Posted
Study publicly available on registry
September 25, 2008
CompletedMarch 9, 2020
March 1, 2020
September 23, 2008
March 5, 2020
Conditions
Keywords
Interventions
Patients will be treated with Prochymal® twice per week at a dose of 2 x 10\^6 hMSC/kg (actual body weight) for each of 4 consecutive weeks. Infusions will be administered at least 3 days apart.
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mesoblast, Inc.lead
Study Sites (27)
Phoenix Children's Hospital
Phoenix, Arizona, 85016, United States
Children's Hospital of Orange County
Orange, California, 92868, United States
UCSF
San Francisco, California, 94143, United States
Children's National
Washington D.C., District of Columbia, 20010, United States
Nemours Children's Clinic
Jacksonville, Florida, 32207, United States
University of Miami
Miami, Florida, 33136, United States
Childrens Memorial
Chicago, Illinois, 60614, United States
James Witcomb Riley Hosptial for Children
Indianapolis, Indiana, 46202, United States
LSU Health Science Center/Children's Hospital
New Orleans, Louisiana, 70118, United States
Wayne State University/Childrens' Hospital
Detroit, Michigan, 48201, United States
Children's Mercy Hospital
Kansas City, Missouri, 64108, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
Hackensack University Medical Center
Hackensack, New Jersey, 07601, United States
Columbia Medical Center
New York, New York, 10032, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, 10065, United States
Levine Children's Hospital
Charlotte, North Carolina, 28232, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
Doernbecher Children's Hospital (OHSU)
Portland, Oregon, 97239, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
Vanderbilt Children's Hospital
Nashville, Tennessee, 37232, United States
Texas Childrens Hospital
Houston, Texas, 77030, United States
Methodist Childrens Hospital of South Texas
San Antonio, Texas, 78229, United States
Massey Cancer Center
Richmond, Virginia, 23298, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
Alberta Children's Hospital
Calgary, Alberta, T3B 6A8, Canada
Montreal Children's Hospital
Montreal, Quebec, H3H1P3, Canada
CHU Sainte-Justine
Montreal, Quebec, H3T1C5, Canada
Related Publications (1)
Kurtzberg J, Prockop S, Chaudhury S, Horn B, Nemecek E, Prasad V, Satwani P, Teira P, Hayes J, Burke E; MSB-275 Study Group. Study 275: Updated Expanded Access Program for Remestemcel-L in Steroid-Refractory Acute Graft-versus-Host Disease in Children. Biol Blood Marrow Transplant. 2020 May;26(5):855-864. doi: 10.1016/j.bbmt.2020.01.026. Epub 2020 Feb 7.
PMID: 32044400DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Mahboob Rahman
Mesoblast, Inc.