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

Phase 2

• Conditions: Stem Cell Transplantation; Hemorrhagic Cystitis; Decidual Stromal Cells
• Interventions: Biological: Decidual stromal cells; Biological: Placebo

• Registration Number: NCT02174536
• Lead Sponsor: Karolinska Institutet

Brief Summary

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

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.

Study Timeline

• Study Start: 2014-03
• Status Verified: 2014-06
• Study First Submitted: 2014-06-23
• Study First Submitted QC: 2014-06-24
• Last Update Submitted: 2014-06-24
• Study First Posted: 2014-06-25
• Last Update Posted: 2014-06-25
• Primary Completion: 2016-12
• Study Completion: 2016-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Hemorrhagic cystitis grade 2-4
• Receives Misoprostol therapy

Exclusion Criteria

• Patients with urinary urge without macroscopic hematuria or clots

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Decidual Stromal cell therapy	Decidual stromal cells	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	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).

Primary Outcome Measures

Name	Time	Method
Days to disappearence of macroscopic hematuria or clots	1 month after inclusion	Each day, patients fill out a form were they state whether they have macroscopic hematuria or not.

Secondary Outcome Measures

Name	Time	Method
Time to disappearance of pain or urges	1 month after inclusion
Time to disappearance of microscopic hematuria	1 month after inclusion	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.
Transplant related mortality	1 year after inclusion	All mortality except relapse
Incidence of severe infections	1 year after inclusion	Incidence of severe bacterial, viral or fungal infections.
Incidence of graft versus host disease	One year after inclusion
Overall actuarial survival	Actuarial

Trial Locations

Locations (1)

Karolinska Institutet; 🇸🇪 Stockholm, Sweden