Prochymal Expanded Access Treatment for Pediatric Patients Who Have Failed Steroids for Acute GVHD
|ClinicalTrials.gov Identifier: NCT00759018|
Recruitment Status : No longer available
First Posted : September 25, 2008
Last Update Posted : October 22, 2015
|Condition or disease||Intervention/treatment|
|Graft vs Host Disease Graft-Versus-Host Disease||Biological: remestemcel-L|
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.
|Study Type :||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|
- Ex-vivo Cultured Adult Human Mesenchymal Stem Cells
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00759018
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