Hemorrhagic Cystitis
Conditions
Keywords
Stem Cell Transplantation, Decidual Stromal Cells
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.
Interventions
BIOLOGICALDecidual Stromal Cell therapy
Intravenous injection with placenta derived Decidual Stromal Cells. 1-2x10\^6 cells/kg.
Sponsors
Karolinska Institutet
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Hemorrhagic cystitis grade 2-4
Exclusion criteria
* Urinary urge without macroscopic hematuria or clots
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Response at day 28 after onset of hemorrhagic cystitis | 28 days after inclusion | Disappearance of macroscopic hematuria. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of graft versus host disease | Up to one year after inclusion | — |
| Actuarial survival at one year after onset of hemorrhagic cystitis | One year after inclusion | — |
| Incidence of severe infections | Up to one year after inclusion | Incidence of severe bacterial, viral or fungal infections. |
| Time to disappearance of microscopic hematuria | Up to 84 days after inclusion | — |
| 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 | — |
Countries
Sweden
Outcome results
None listed