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 : October 22, 2015
|First Submitted Date||September 23, 2008|
|First Posted Date||September 25, 2008|
|Last Update Posted Date||October 22, 2015|
|Brief Title||Prochymal Expanded Access Treatment for Pediatric Patients Who Have Failed Steroids for Acute GVHD|
|Brief Summary||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.
|Study Type||Expanded Access|
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.
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Expanded Access Status||No longer available|
|Contacts||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries||Canada, United States|
|Removed Location Countries|
|Responsible Party||Mesoblast, Ltd. ( Mesoblast International Sàrl )|
|Study Sponsor||Mesoblast International Sàrl|
|PRS Account||Mesoblast, Ltd.|
|Verification Date||October 2015|