Mesenchymal Stromal Cells as Treatment of Chronic Graft-versus-host Disease
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|ClinicalTrials.gov Identifier: NCT01522716|
Recruitment Status : Unknown
Verified May 2016 by Lena von Bahr, Karolinska Institutet.
Recruitment status was: Active, not recruiting
First Posted : February 1, 2012
Last Update Posted : June 1, 2016
|Condition or disease||Intervention/treatment||Phase|
|Graft-Versus-Host Disease||Biological: Mesenchymal stromal cells||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||11 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Mesenchymal Stromal Cells as Treatment of Chronic Graft-versus-host Disease|
|Study Start Date :||August 2011|
|Actual Primary Completion Date :||March 2016|
|Estimated Study Completion Date :||March 2017|
|Experimental: Mesenchymal stromal cell treatment||
Biological: Mesenchymal stromal cells
Allogenous mesenchymal stromal cells, to be injected intravenously at a dose of 1-2 million/kg at a frequency of once a month (frequency may be changed during the study if deemed appropriate by investigators) for 6-9 months.
- Change in disease activity according to National Institute of Health criteria [ Time Frame: Baseline to 9 months ]
- Change in disease activity as measured by histological examination [ Time Frame: Baseline to 9 months ]
- Change in self-assessed disease activity and quality of life [ Time Frame: Baseline to 9 months ]
- Safety [ Time Frame: 21 months ]Frequency of complications, infections and relapse
- Freedom from steroids at 1 year after MSC treatment [ Time Frame: 1 year after finishing treatment ]Proportion of patients free from corticosteroids at 1 year after finishing MSC treatment.
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): NCT01522716
|Hematology Center, Karolinska University Hospital Huddinge|