Decidua Stroma Cells for Steroid Resistent Acute Graft-versus-host Disease After Allo-HSCT
Trial Parameters
Brief Summary
A randomized (1:1) phase II open label study of DSC compared to Investigator choice Best Available Therapy (BAT) in allogeneic hematopoietic stem cell transplant recipients with Grades II-IV steroid refractory acute graft vs. host disease in the second part of the study. Patients will receive 2 doses of DSC. Additional doses (up to 4 doses) may be given depending on response. No cross-over are planned in the second stage of the study.
Eligibility Criteria
Inclusion Criteria: 1. Adult patients (age ≥ 18 years) with steroid refractory acute GvHD grades II-IV after allo-HSCT. 2. Signed written study informed consent once SR-aGvHD is confirmed. Exclusion Criteria: 1. Presence of an active uncontrolled infection including significant bacterial, fungal, viral or parasitic infection requiring treatment. 2. Has received systemic treatment for aGvHD apart from steroids. 3. Clinical presentation resembling de novo chronic GvHD or GvHD overlap syndrome. 4. Pregnant or lactating women. 5. Significant respiratory disease. 6. Presence of severely impaired renal function 7. Any corticosteroid therapy for indications other than aGvHD 8. Previous participation in a study of any investigational treatment agent within 30 days 9. Known human immunodeficiency virus infection (HIV). 10. Patients suffering on active tuberculosis or viral hepatitis 11. Significant respiratory disease 12. Presence of severely impaired renal or liver function 13. History of prog