Back to resultsA Pilot Study Using Placenta Derived Decidual Stromal Cells for Hemorrhagic Cystitis
Primary Purpose
Hemorrhagic Cystitis
Status
Completed
Phase
Phase 1
Locations
Sweden
Study Type
Interventional
Intervention
Decidual Stromal Cell therapy
Sponsored by
About this trial
This is an interventional treatment trial for Hemorrhagic Cystitis focused on measuring Stem Cell Transplantation, Decidual Stromal Cells
Eligibility Criteria
Inclusion Criteria:
- Hemorrhagic cystitis grade 2-4
Exclusion Criteria:
- Urinary urge without macroscopic hematuria or clots
Sites / Locations
- Karolinska Institutet
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Decidual Stromal Cell therapy for Hemorrhagic Cystitis
Arm Description
Outcomes
Primary Outcome Measures
Response at day 28 after onset of hemorrhagic cystitis
Disappearance of macroscopic hematuria.
Secondary Outcome Measures
Actuarial survival at one year after onset of hemorrhagic cystitis
Time to disappearance of pain or urges
Time to disappearance of microscopic hematuria
Transplant related mortality
All mortality except for relapse
Incidence of severe infections
Incidence of severe bacterial, viral or fungal infections.
Incidence of graft versus host disease
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02172963
Brief Title
A Pilot Study Using Placenta Derived Decidual Stromal Cells for Hemorrhagic Cystitis
Study Type
Interventional
2. Study Status
Record Verification Date
June 2014
Overall Recruitment Status
Completed
Study Start Date
November 2011 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska Institutet
4. Oversight
5. Study Description
Brief 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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemorrhagic Cystitis
Keywords
Stem Cell Transplantation, Decidual Stromal Cells
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Decidual Stromal Cell therapy for Hemorrhagic Cystitis
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
Decidual Stromal Cell therapy
Intervention Description
Intravenous injection with placenta derived Decidual Stromal Cells. 1-2x10^6 cells/kg.
Primary Outcome Measure Information:
Title
Response at day 28 after onset of hemorrhagic cystitis
Description
Disappearance of macroscopic hematuria.
Time Frame
28 days after inclusion
Secondary Outcome Measure Information:
Title
Actuarial survival at one year after onset of hemorrhagic cystitis
Time Frame
One year after inclusion
Title
Time to disappearance of pain or urges
Time Frame
Up to 6 months after inclusion
Title
Time to disappearance of microscopic hematuria
Time Frame
Up to 84 days after inclusion
Title
Transplant related mortality
Description
All mortality except for relapse
Time Frame
Up to one year after inclusion
Title
Incidence of severe infections
Description
Incidence of severe bacterial, viral or fungal infections.
Time Frame
Up to one year after inclusion
Title
Incidence of graft versus host disease
Time Frame
Up to one year after inclusion
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Hemorrhagic cystitis grade 2-4
Exclusion Criteria:
Urinary urge without macroscopic hematuria or clots
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Olle Ringdén, MD, PhD
Organizational Affiliation
Karolinska Institutet
Official's Role
Principal Investigator
Facility Information:
Facility Name
Karolinska Institutet
City
Stockholm
ZIP/Postal Code
14186
Country
Sweden
12. IPD Sharing Statement
Learn more about this trial
A Pilot Study Using Placenta Derived Decidual Stromal Cells for Hemorrhagic Cystitis
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