NCT02174536

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Karolinska Institutet · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Hemorrhagic Cystitis
• Stem Cell Transplantation
• Decidual Stromal Cells

Interventions

Type	Name	Description
BIOLOGICAL	Decidual stromal cells	Decidual stromal cells (approximately 1x10\^6 cells/kg) will be infused intravenously.
BIOLOGICAL	Placebo

Timeline

• Start date: 2014-03-01
• Primary completion: 2016-12-01
• Completion: 2016-12-01
• First posted: 2014-06-25
• Last updated: 2014-06-25

Locations

1 site across 1 country: Sweden