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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Decidual Stromal cell therapy | Active Comparator | Decidual stromal cell therapy (approximately 1x10^6 cells/kg) for hemorrhagic cystitis in addition to Misoprostol therapy (0,2mg, 3 times/day) on two occasions at weekly intervals. |
|
| Placebo | Placebo Comparator | Receives placebo (masked i.v. infusion, same amount as an infusion of decidual stromal cells) in addition to Misoprostol therapy (0,2mg, 3 times/day). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Decidual stromal cells | Biological | Decidual stromal cells (approximately 1x10^6 cells/kg) will be infused intravenously. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Days to disappearence of macroscopic hematuria or clots | Each day, patients fill out a form were they state whether they have macroscopic hematuria or not. | 1 month after inclusion |
| Measure | Description | Time Frame |
|---|---|---|
| Time to disappearance of pain or urges | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Olle Ringdén, MD, PhD | Contact | +46858582672 | olle.ringden@ki.se | |
| Helen Kaipe, PhD | Contact | +46700901052 | helen.kaipe@ki.se |
| Name | Affiliation | Role |
|---|---|---|
| Olle Ringdén, MD, PhD | Karolinska Institutet | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Karolinska Institutet | Recruiting | Stockholm | Stockholm County | 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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| Placebo | Biological |
|
| 1 month after inclusion |
| Transplant related mortality | All mortality except relapse | 1 year after inclusion |
| Incidence of severe infections | Incidence of severe bacterial, viral or fungal infections. | 1 year after inclusion |
| Incidence of graft versus host disease | One year after inclusion |
| Overall actuarial survival | Actuarial |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |