Mesenchymal Stromal Cells as Treatment of Chronic Graft-versus-host Disease
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|ClinicalTrials.gov Identifier: NCT01522716|
Recruitment Status : Terminated (New requirements for study approval with the Swedish Medical Products Agency)
First Posted : February 1, 2012
Last Update Posted : November 25, 2020
|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|
|Actual 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 ]Patients are evaluated according to NIH criteria at 3, 6 and (if applicable) 9 months after initialising MSC treatment, and the score compared to baseline score.
- 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 (Adverse events, infections and relapse) [ 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|