A Double Blind Randomized Study Using Placenta Derived Decidual Stromal Cells for Hemorrhagic Cystitis

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Conditions
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Hemorrhagic Cystitis, Stem Cell Transplantation, Decidual Stromal Cells

Intervention / Treatment
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* Biological: Decidual stromal cells
* Biological: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Hemorrhagic cystitis grade 2-4 Receives Misoprostol therapy Exclusion Criteria: Patients with urinary urge without macroscopic hematuria or clots
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Decidual Stromal cell therapy<br>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. | Biological: Decidual stromal cells<br>* Decidual stromal cells (approximately 1x10^6 cells/kg) will be infused intravenously.<br>|
| Placebo Comparator: Placebo<br>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). | Biological: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. | 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 |