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
2 Months
17 Years
Both
Graft vs Host Disease, Graft-Versus-Host Disease
Trial Information
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
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 hMSC/kg (actual
body weight) for each of 4 consecutive weeks. Infusions will be administered at least 3
days apart.
Inclusion Criteria:
- Patients must be 2 months to 17 years of age, inclusive
- Patients who have failed to respond to steroid treatment for Grades B-D acute GVHD
- Patient must not have a known allergy to bovine or porcine products
- Patient must not have received a transplant for a solid tumor disease.
- Patient must not have evidence of a pulmonary infiltrate or diffuse alveolar
hemorrhage and is likely to require more than 2L of oxygen via face mask or an
estimated FiO2 of 28% via other delivery methods in order to sustain an O2 saturation
of 92% during the next 3 days.
Type of Study:
Expanded Access
Study Design:
N/A
Authority:
United States: Food and Drug Administration
Study ID:
275
NCT ID:
NCT00759018
Start Date:
Completion Date:
Related Keywords:
- Graft Vs Host Disease
- Graft-Versus-Host Disease
- GVHD
- Prochymal
- Graft vs Host Disease
- Graft vs Host Disease
Name | Location |
|---|---|
| UCSF | San Francisco, California 941430324 |
| Memorial Sloan-Kettering Cancer Center | New York, New York 10021 |
| Washington University School of Medicine | Saint Louis, Missouri 63110 |
| Medical University of South Carolina | Charleston, South Carolina 29425-0721 |
| Medical College of Wisconsin | Milwaukee, Wisconsin 53226 |
| Massey Cancer Center | Richmond, Virginia 23298-0037 |
| Hackensack University Medical Center | Hackensack, New Jersey 07601 |
| Children's Hospital of Orange County | Orange, California 92668 |
| Children's Mercy Hospital | Kansas City, Missouri 64108 |
| Nemours Children's Clinic | Jacksonville, Florida 32207 |
| Phoenix Children's Hospital | Phoenix, Arizona 85016-7710 |
| Vanderbilt Children's Hospital | Nashville, Tennessee 37232-6310 |
| Duke University Medical Center | Durham, North Carolina 27710 |
| University of Miami | Miami, Florida 33136 |
| Texas Childrens Hospital | Houston, Texas 77030 |
| Levine Children's Hospital | Charlotte, North Carolina 28204 |
| Children's National | Washington, District of Columbia 20010 |
| Childrens Memorial | Chicago, Illinois 60614 |
| James Witcomb Riley Hosptial for Children | Indianapolis, Indiana 46202 |
| LSU Health Science Center/Children's Hospital | New Orleans, Louisiana 70118 |
| Wayne State University/Childrens' Hospital | Detroit, Michigan 48201 |
| Columbia Medical Center | New York, New York 10032 |
| Doernbecher Children's Hospital (OHSU) | Portland, Oregon 97239 |
| Methodist Childrens Hospital of South Texas | San Antonio, Texas 78229 |
