A Double Blind Randomized Study Using Placenta Derived Decidual Stromal Cells for Hemorrhagic Cystitis
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|ClinicalTrials.gov Identifier: NCT02174536|
Recruitment Status : Unknown
Verified June 2014 by Olle Ringdén, Karolinska Institutet.
Recruitment status was: Recruiting
First Posted : June 25, 2014
Last Update Posted : June 25, 2014
|Condition or disease||Intervention/treatment||Phase|
|Hemorrhagic Cystitis Stem Cell Transplantation Decidual Stromal Cells||Biological: Decidual stromal cells Biological: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Study Start Date :||March 2014|
|Estimated Primary Completion Date :||December 2016|
|Estimated Study Completion Date :||December 2016|
Active Comparator: 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.
Biological: Decidual stromal cells
Decidual stromal cells (approximately 1x10^6 cells/kg) will be infused intravenously.
Placebo Comparator: 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).
- Days to disappearence of macroscopic hematuria or clots [ Time Frame: 1 month after inclusion ]Each day, patients fill out a form were they state whether they have macroscopic hematuria or not.
- Time to disappearance of pain or urges [ Time Frame: 1 month after inclusion ]
- Time to disappearance of microscopic hematuria [ Time Frame: 1 month after inclusion ]Each day patients, with the help of a urinary test stick, fill out a form were they state whether they have microscopic hematuria or not.
- Transplant related mortality [ Time Frame: 1 year after inclusion ]All mortality except relapse
- Incidence of severe infections [ Time Frame: 1 year after inclusion ]Incidence of severe bacterial, viral or fungal infections.
- Incidence of graft versus host disease [ Time Frame: One year after inclusion ]
- Overall actuarial survival [ Time Frame: Actuarial ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02174536
|Contact: Olle Ringdén, MD, PhDfirstname.lastname@example.org|
|Contact: Helen Kaipe, PhDemail@example.com|
|Stockholm, Sweden, 14186|
|Contact: Olle Ringdén, MD, PhD +46858582672 firstname.lastname@example.org|
|Principal Investigator: Olle Ringdén, MD, PhD|
|Principal Investigator:||Olle Ringdén, MD, PhD||Karolinska Institutet|