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

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02174536

Enrollment

Registered

2014-06-25

Start date

2014-03-31

Completion date

2016-12-31

Last updated

2014-06-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Decidual Stromal Cells, Hemorrhagic Cystitis, Stem Cell Transplantation

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.

Interventions

BIOLOGICALDecidual stromal cells

Decidual stromal cells (approximately 1x10\^6 cells/kg) will be infused intravenously.

BIOLOGICALPlacebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion criteria

* Hemorrhagic cystitis grade 2-4 * Receives Misoprostol therapy

Exclusion criteria

* Patients with urinary urge without macroscopic hematuria or clots

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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
Time to disappearance of pain or urges	1 month after inclusion	—
Incidence of graft versus host disease	One year after inclusion	—
Overall actuarial survival	Actuarial	—
Incidence of severe infections	1 year after inclusion	Incidence of severe bacterial, viral or fungal infections.

Countries

Sweden

Contacts

Primary ContactOlle Ringdén, MD, PhD

olle.ringden@ki.se+46858582672

Backup ContactHelen Kaipe, PhD

helen.kaipe@ki.se+46700901052

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026