The aim of the study is to evaluate the safety and efficacy of mesenchymal stromal cells as treatment for steroid-refractory chronic graft-versus-host disease.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
11
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.
Hematology Center, Karolinska University Hospital Huddinge
Stockholm, Sweden
Change in disease activity according to National Institute of Health criteria
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.
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 (Adverse events, infections and relapse)
Frequency of complications, infections and relapse
Time frame: 21 months
Freedom from steroids at 1 year after MSC treatment
Proportion of patients free from corticosteroids at 1 year after finishing MSC treatment.
Time frame: 1 year after finishing treatment
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