A Pilot Study Using Placenta Derived Decidual Stromal Cells for Hemorrhagic Cystitis
Phase 1
Completed
- Conditions
- Hemorrhagic Cystitis
- Registration Number
- NCT02172963
- Lead Sponsor
- Karolinska Institutet
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 12
Inclusion Criteria
- Hemorrhagic cystitis grade 2-4
Exclusion Criteria
- Urinary urge without macroscopic hematuria or clots
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Response at day 28 after onset of hemorrhagic cystitis 28 days after inclusion Disappearance of macroscopic hematuria.
- Secondary Outcome Measures
Name Time Method Transplant related mortality Up to one year after inclusion All mortality except for relapse
Time to disappearance of pain or urges Up to 6 months after inclusion Actuarial survival at one year after onset of hemorrhagic cystitis One year after inclusion Time to disappearance of microscopic hematuria Up to 84 days after inclusion Incidence of severe infections Up to one year after inclusion Incidence of severe bacterial, viral or fungal infections.
Incidence of graft versus host disease Up to one year after inclusion
Trial Locations
- Locations (1)
Karolinska Institutet
🇸🇪Stockholm, Sweden
Karolinska Institutet🇸🇪Stockholm, Sweden