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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02172963
Other study ID # DSCHC001
Secondary ID
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


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
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