The purpose of this study is to evaluate the safety and efficacy using placenta derived decidual stromal cell therapy for hemorrhagic cystitis after allogeneic hematopoietic cell transplantation. It is hypothesized that the decidual stromal cell therapy is safe to infuse and that they have a positive clinical effect.
Patients with grade 2-4 hemorrhagic cystitis will receive decidual stromal cell therapy at approximately 1-2x10\^6 cells/kg once or at weekly intervals dependent on clinical effect.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
12
Intravenous injection with placenta derived Decidual Stromal Cells. 1-2x10\^6 cells/kg.
Karolinska Institutet
Stockholm, Sweden
Response at day 28 after onset of hemorrhagic cystitis
Disappearance of macroscopic hematuria.
Time frame: 28 days after inclusion
Actuarial survival at one year after onset of hemorrhagic cystitis
Time frame: One year after inclusion
Time to disappearance of pain or urges
Time frame: Up to 6 months after inclusion
Time to disappearance of microscopic hematuria
Time frame: Up to 84 days after inclusion
Transplant related mortality
All mortality except for relapse
Time frame: Up to one year after inclusion
Incidence of severe infections
Incidence of severe bacterial, viral or fungal infections.
Time frame: Up to one year after inclusion
Incidence of graft versus host disease
Time frame: Up to one year after inclusion
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