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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Decidual Stromal Cell therapy for Hemorrhagic Cystitis | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Decidual Stromal Cell therapy | Biological | Intravenous injection with placenta derived Decidual Stromal Cells. 1-2x10^6 cells/kg. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Response at day 28 after onset of hemorrhagic cystitis | Disappearance of macroscopic hematuria. | 28 days after inclusion |
| Measure | Description | Time Frame |
|---|---|---|
| Actuarial survival at one year after onset of hemorrhagic cystitis | One year after inclusion | |
| Time to disappearance of pain or urges | Up to 6 months after inclusion | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Olle Ringdén, MD, PhD | Karolinska Institutet | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Karolinska Institutet | Stockholm | 14186 | Sweden |
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| ID | Term |
|---|---|
| D000096722 | Cystitis, Hemorrhagic |
| ID | Term |
|---|---|
| D003556 | Cystitis |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| Time to disappearance of microscopic hematuria |
| Up to 84 days after inclusion |
| Transplant related mortality | All mortality except for relapse | Up to one year after inclusion |
| Incidence of severe infections | Incidence of severe bacterial, viral or fungal infections. | Up to one year after inclusion |
| Incidence of graft versus host disease | Up to one year after inclusion |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |