A Double Blind Randomized Study Using Placenta Derived Decidual Stromal Cells for Hemorrhagic Cystitis
1 other identifier
interventional
20
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Mar 2014
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2014
CompletedFirst Submitted
Initial submission to the registry
June 23, 2014
CompletedFirst Posted
Study publicly available on registry
June 25, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2016
CompletedJune 25, 2014
June 1, 2014
2.8 years
June 23, 2014
June 24, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (6)
Time to disappearance of pain or urges
1 month after inclusion
Time to disappearance of microscopic hematuria
1 month after inclusion
Transplant related mortality
1 year after inclusion
Incidence of severe infections
1 year after inclusion
Incidence of graft versus host disease
One year after inclusion
- +1 more secondary outcomes
Study Arms (2)
Decidual Stromal cell therapy
ACTIVE COMPARATORDecidual stromal cell therapy (approximately 1x10\^6 cells/kg) for hemorrhagic cystitis in addition to Misoprostol therapy (0,2mg, 3 times/day) on two occasions at weekly intervals.
Placebo
PLACEBO COMPARATORReceives placebo (masked i.v. infusion, same amount as an infusion of decidual stromal cells) in addition to Misoprostol therapy (0,2mg, 3 times/day).
Interventions
Decidual stromal cells (approximately 1x10\^6 cells/kg) will be infused intravenously.
Eligibility Criteria
You may qualify if:
- Hemorrhagic cystitis grade 2-4
- Receives Misoprostol therapy
You may not qualify if:
- Patients with urinary urge without macroscopic hematuria or clots
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Karolinska Institutet
Stockholm, Stockholm County, 14186, Sweden
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Olle Ringdén, MD, PhD
Karolinska Institutet
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
June 23, 2014
First Posted
June 25, 2014
Study Start
March 1, 2014
Primary Completion
December 1, 2016
Study Completion
December 1, 2016
Last Updated
June 25, 2014
Record last verified: 2014-06