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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


N/A
2 Months
17 Years
Open (Enrolling)
Both
Graft vs Host Disease, Graft-Versus-Host Disease

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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

UCSFSan Francisco, California  941430324
Memorial Sloan-Kettering Cancer CenterNew York, New York  10021
Washington University School of MedicineSaint Louis, Missouri  63110
Medical University of South CarolinaCharleston, South Carolina  29425-0721
Medical College of WisconsinMilwaukee, Wisconsin  53226
Massey Cancer CenterRichmond, Virginia  23298-0037
Hackensack University Medical CenterHackensack, New Jersey  07601
Children's Hospital of Orange CountyOrange, California  92668
Children's Mercy HospitalKansas City, Missouri  64108
Nemours Children's ClinicJacksonville, Florida  32207
Phoenix Children's HospitalPhoenix, Arizona  85016-7710
Vanderbilt Children's HospitalNashville, Tennessee  37232-6310
Duke University Medical CenterDurham, North Carolina  27710
University of MiamiMiami, Florida  33136
Texas Childrens HospitalHouston, Texas  77030
Levine Children's HospitalCharlotte, North Carolina  28204
Children's NationalWashington, District of Columbia  20010
Childrens MemorialChicago, Illinois  60614
James Witcomb Riley Hosptial for ChildrenIndianapolis, Indiana  46202
LSU Health Science Center/Children's HospitalNew Orleans, Louisiana  70118
Wayne State University/Childrens' HospitalDetroit, Michigan  48201
Columbia Medical CenterNew York, New York  10032
Doernbecher Children's Hospital (OHSU)Portland, Oregon  97239
Methodist Childrens Hospital of South TexasSan Antonio, Texas  78229