Prochymal Expanded Access Treatment for Pediatric Patients Who Have Failed Steroids for Acute GVHD
|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.|
|ClinicalTrials.gov Identifier: NCT00759018|
Expanded Access Status : No longer available
First Posted : September 25, 2008
Last Update Posted : March 9, 2020
|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 hematopoietic stem cells (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|
- 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:
- Ex-vivo Cultured Adult Human Mesenchymal Stem Cells
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
|Study Director:||Mahboob Rahman||Mesoblast, Inc.|