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

Stem Cell Transplantation Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02174536
• Other study ID #: DSCHC002
• Status: Recruiting
• Phase: Phase 2
• First received: June 23, 2014
• Last updated: June 24, 2014
• Start date: March 2014
• Est. completion date: December 2016

Study information

• Verified date: June 2014
• Source: Karolinska Institutet
• Contact: Olle Ringdén, MD, PhD
• Phone: +46858582672
• Email: olle.ringden[@]ki.se
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Hemorrhagic cystitis grade 2-4

• Receives Misoprostol therapy

Exclusion Criteria:

• Patients with urinary urge without macroscopic hematuria or clots

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cystitis
• Decidual Stromal Cells
• Hemorrhagic Cystitis
• Stem Cell Transplantation

Intervention

Biological:
• Decidual stromal cells
Decidual stromal cells (approximately 1x10^6 cells/kg) will be infused intravenously.
• Placebo

Locations

Country	Name	City	State
Sweden	Karolinska Institutet	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Time to disappearance of pain or urges		1 month after inclusion	No
Secondary	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	No
Secondary	Transplant related mortality	All mortality except relapse	1 year after inclusion	Yes
Secondary	Incidence of severe infections	Incidence of severe bacterial, viral or fungal infections.	1 year after inclusion	Yes
Secondary	Incidence of graft versus host disease		One year after inclusion	Yes
Secondary	Overall actuarial survival		Actuarial	No