Chronic Graft-versus-Host Disease (cGvHD) is a potentially lethal disorder. A variety of second line immunosuppressive agents have been investigated but no optimal treatment has emerged. There is therefore a need for novel treatment strategies. Mesenchymal stromal cells (MSC) exhibit immunomodulatory properties and a recent pilot study suggests a response rate of 70% in steroid- refractory patients. In the present randomized study the efficacy and safety of MSC treatment will be further studied in patients with cGvHD.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
130
Mesenchymal stem cell(MSC). Patients with newly diagnosed cGvHD: prednisone 1mg/kg + cyclosporine or tacrolimus and MSC 2×1,000,000 MSC/kg, IV twice a week for the first two weeks and weekly for the following two weeks(6 doses totally).
Xin Du
Guangzhou, Guangdong, China
RECRUITINGProportion of patients responding to treatment of cGvHD with MSC
Time frame: 90 days
Overall survival
Time frame: 2 year
Progression-free survival
Time frame: 2 year
Time without systemic immunosuppression
Time frame: 2 year
Cumulative incidents of non-relapse mortality
Time frame: 2 year
Adverse events
Time frame: 2 year
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