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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 )
September 23, 2008
September 25, 2008
October 22, 2015
 
Prochymal Expanded Access Treatment for Pediatric Patients Who Have Failed Steroids for Acute GVHD
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.

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.

Expanded Access
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
Not Provided
 
No longer available
Contact information is only displayed when the study is recruiting subjects
Canada,   United States
 
 
NCT00759018
Mesoblast, Ltd. ( Mesoblast International Sàrl )
Mesoblast International Sàrl
Not Provided
Not Provided
Mesoblast, Ltd.
October 2015