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

Karolinska Institute

Status and phase: Unknown; Phase 2

Conditions: Stem Cell Transplantation; Hemorrhagic Cystitis; Decidual Stromal Cells

Treatments: Biological: Placebo; Biological: Decidual stromal cells

Study type: Interventional

Funder types: Other

Identifiers

NCT02174536

DSCHC002

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Hemorrhagic cystitis grade 2-4
• Receives Misoprostol therapy

Exclusion criteria

• Patients with urinary urge without macroscopic hematuria or clots

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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20 participants in 2 patient groups, including a placebo group

Decidual Stromal cell therapy

Active Comparator group

Description:

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.

Treatment:

Biological: Decidual stromal cells

Placebo

Placebo Comparator group

Description:

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).

Treatment:

Biological: Placebo