A Double Blind Randomized Study Using Placenta Derived Decidual Stromal Cells for Hemorrhagic Cystitis
NCT ID: NCT02174536
Last Updated: 2014-06-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
20 participants
INTERVENTIONAL
2014-03-31
2016-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Decidual Stromal cell therapy
Decidual 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.
Decidual stromal cells
Decidual stromal cells (approximately 1x10\^6 cells/kg) will be infused intravenously.
Placebo
Receives placebo (masked i.v. infusion, same amount as an infusion of decidual stromal cells) in addition to Misoprostol therapy (0,2mg, 3 times/day).
Placebo
Interventions
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Decidual stromal cells
Decidual stromal cells (approximately 1x10\^6 cells/kg) will be infused intravenously.
Placebo
Eligibility Criteria
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Inclusion Criteria
* Receives Misoprostol therapy
Exclusion Criteria
ALL
No
Sponsors
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Karolinska Institutet
OTHER
Responsible Party
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Olle Ringdén
Professor
Principal Investigators
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Olle Ringdén, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Karolinska Institutet
Locations
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Karolinska Institutet
Stockholm, Stockholm County, Sweden
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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DSCHC002
Identifier Type: -
Identifier Source: org_study_id
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