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

Expanded access is no longer available for this treatment.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00759018
First Posted: September 25, 2008
Last Update Posted: October 22, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Mesoblast, Ltd. ( Mesoblast International Sàrl )
  Purpose
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.

Condition Intervention
Graft vs Host Disease Graft-Versus-Host Disease Biological: remestemcel-L

Study Type: Expanded Access     What is Expanded Access?
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Mesoblast, Ltd. ( Mesoblast International Sàrl ):

Intervention Details:
    Biological: remestemcel-L
    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.
    Other Names:
    • Prochymal®
    • Ex-vivo Cultured Adult Human Mesenchymal Stem Cells
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 hMSC/kg (actual body weight) for each of 4 consecutive weeks. Infusions will be administered at least 3 days apart.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   2 Months to 17 Years   (Child)
Sexes Eligible for Study:   All
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00759018


  Hide Study Locations
Locations
United States, Arizona
Phoenix Children's Hospital
Phoenix, Arizona, United States, 85016
United States, California
Children's Hospital of Orange County
Orange, California, United States, 92868
UCSF
San Francisco, California, United States, 94143
United States, District of Columbia
Children's National
Washington, District of Columbia, United States, 20010
United States, Florida
Nemours Children's Clinic
Jacksonville, Florida, United States, 32207
University of Miami
Miami, Florida, United States, 33136
United States, Illinois
Childrens Memorial
Chicago, Illinois, United States, 60614
United States, Indiana
James Witcomb Riley Hosptial for Children
Indianapolis, Indiana, United States, 46202
United States, Louisiana
LSU Health Science Center/Children's Hospital
New Orleans, Louisiana, United States, 70118
United States, Michigan
Wayne State University/Childrens' Hospital
Detroit, Michigan, United States, 48201
United States, Missouri
Children's Mercy Hospital
Kansas City, Missouri, United States, 64108
Washington University School of Medicine
St. Louis, Missouri, United States, 63110
United States, New Jersey
Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
United States, New York
Columbia Medical Center
New York, New York, United States, 10032
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10065
United States, North Carolina
Levine Children's Hospital
Charlotte, North Carolina, United States, 28232
Duke University Medical Center
Durham, North Carolina, United States, 27710
United States, Oregon
Doernbecher Children's Hospital (OHSU)
Portland, Oregon, United States, 97239
United States, South Carolina
Medical University of South Carolina
Charlston, South Carolina, United States, 29425
United States, Tennessee
Vanderbilt Children's Hospital
Nashville, Tennessee, United States, 37232
United States, Texas
Texas Childrens Hospital
Houston, Texas, United States, 77030
Methodist Childrens Hospital of South Texas
San Antonio, Texas, United States, 78229
United States, Virginia
Massey Cancer Center
Richmond, Virginia, United States, 23298
United States, Wisconsin
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Canada, Quebec
Montreal Children's Hospital
Montreal, Quebec, Canada, H3H1P3
CHU Sainte-Justine
Montreal, Quebec, Canada, H3T1C5
Canada
Alberta Children's Hospital
Alberta, Canada, T3B 6A8
Sponsors and Collaborators
Mesoblast International Sàrl
  More Information

Responsible Party: Mesoblast International Sàrl
ClinicalTrials.gov Identifier: NCT00759018     History of Changes
Other Study ID Numbers: 275
First Submitted: September 23, 2008
First Posted: September 25, 2008
Last Update Posted: October 22, 2015
Last Verified: October 2015

Keywords provided by Mesoblast, Ltd. ( Mesoblast International Sàrl ):
GVHD
Prochymal
Graft vs Host Disease

Additional relevant MeSH terms:
Graft vs Host Disease
Immune System Diseases