A prospective double blind randomized study comparing placenta derived decidual stromal cells with placebo for hemorrhagic cystitis after allogeneic hematopoietic cell transplantation. It is hypothesized that the decidual stromal cell therapy will be superior to placebo.
Patients with grade 2-4 hemorrhagic cystitis will be randomized to receive either decidual stromal cell therapy at approximately 1x106 cells/kg or placebo on two occasions at weekly intervals. Patients not responsive within 2 weeks will receive decidual stromal cells at approximately 1x106 cells/kg openly.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
20
Decidual stromal cells (approximately 1x10\^6 cells/kg) will be infused intravenously.
Karolinska Institutet
Stockholm, Stockholm County, Sweden
RECRUITINGDays to disappearence of macroscopic hematuria or clots
Each day, patients fill out a form were they state whether they have macroscopic hematuria or not.
Time frame: 1 month after inclusion
Time to disappearance of pain or urges
Time frame: 1 month after inclusion
Time to disappearance of microscopic hematuria
Each day patients, with the help of a urinary test stick, fill out a form were they state whether they have microscopic hematuria or not.
Time frame: 1 month after inclusion
Transplant related mortality
All mortality except relapse
Time frame: 1 year after inclusion
Incidence of severe infections
Incidence of severe bacterial, viral or fungal infections.
Time frame: 1 year after inclusion
Incidence of graft versus host disease
Time frame: One year after inclusion
Overall actuarial survival
Time frame: Actuarial
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