A Pilot Study Using Placenta Derived Decidual Stromal Cells for Hemorrhagic Cystitis

Hemorrhagic Cystitis Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02172963
• Other study ID #: DSCHC001
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: June 18, 2014
• Last updated: June 23, 2014
• Start date: November 2011
• Est. completion date: December 2013

Study information

• Verified date: June 2014
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the safety and efficacy using placenta derived decidual stromal cell therapy for hemorrhagic cystitis after allogeneic hematopoietic cell transplantation. It is hypothesized that the decidual stromal cell therapy is safe to infuse and that they have a positive clinical effect.

Description:

Patients with grade 2-4 hemorrhagic cystitis will receive decidual stromal cell therapy at approximately 1-2x10^6 cells/kg once or at weekly intervals dependent on clinical effect.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Hemorrhagic cystitis grade 2-4

Exclusion Criteria:

• Urinary urge without macroscopic hematuria or clots

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cystitis
• Hemorrhagic Cystitis

Intervention

Biological:
• Decidual Stromal Cell therapy
Intravenous injection with placenta derived Decidual Stromal Cells. 1-2x10^6 cells/kg.

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	Response at day 28 after onset of hemorrhagic cystitis	Disappearance of macroscopic hematuria.	28 days after inclusion	No
Secondary	Actuarial survival at one year after onset of hemorrhagic cystitis		One year after inclusion	No
Secondary	Time to disappearance of pain or urges		Up to 6 months after inclusion	No
Secondary	Time to disappearance of microscopic hematuria		Up to 84 days after inclusion	No
Secondary	Transplant related mortality	All mortality except for relapse	Up to one year after inclusion	No
Secondary	Incidence of severe infections	Incidence of severe bacterial, viral or fungal infections.	Up to one year after inclusion	Yes
Secondary	Incidence of graft versus host disease		Up to one year after inclusion	Yes