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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
Sponsor:
Information provided by (Responsible Party):
Olle Ringdén, Karolinska Institutet

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.

Condition or disease Intervention/treatment Phase
Hemorrhagic Cystitis Stem Cell Transplantation Decidual Stromal Cells Biological: Decidual stromal cells Biological: Placebo Phase 2

Detailed Description:
Patients with grade 2-4 hemorrhagic cystitis will be randomized to receive either decidual stromal cell therapy at approximately 1x106 cells/kg or placebo on two occasions at weekly intervals. Patients not responsive within 2 weeks will receive decidual stromal cells at approximately 1x106 cells/kg openly.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : March 2014
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : December 2016

Arm Intervention/treatment
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).
Biological: Placebo



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Time to disappearance of pain or urges [ Time Frame: 1 month after inclusion ]
  2. 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.

  3. Transplant related mortality [ Time Frame: 1 year after inclusion ]
    All mortality except relapse

  4. Incidence of severe infections [ Time Frame: 1 year after inclusion ]
    Incidence of severe bacterial, viral or fungal infections.

  5. Incidence of graft versus host disease [ Time Frame: One year after inclusion ]
  6. Overall actuarial survival [ Time Frame: Actuarial ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Hemorrhagic cystitis grade 2-4
  • Receives Misoprostol therapy

Exclusion Criteria:

  • Patients with urinary urge without macroscopic hematuria or clots

Information from the National Library of Medicine

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


Contacts
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Contact: Olle Ringdén, MD, PhD +46858582672 olle.ringden@ki.se
Contact: Helen Kaipe, PhD +46700901052 helen.kaipe@ki.se

Locations
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Sweden
Karolinska Institutet Recruiting
Stockholm, Sweden, 14186
Contact: Olle Ringdén, MD, PhD    +46858582672    olle.ringden@ki.se   
Principal Investigator: Olle Ringdén, MD, PhD         
Sponsors and Collaborators
Karolinska Institutet
Investigators
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Principal Investigator: Olle Ringdén, MD, PhD Karolinska Institutet
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Responsible Party: Olle Ringdén, Professor, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT02174536    
Other Study ID Numbers: DSCHC002
First Posted: June 25, 2014    Key Record Dates
Last Update Posted: June 25, 2014
Last Verified: June 2014
Additional relevant MeSH terms:
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Cystitis
Urinary Bladder Diseases
Urologic Diseases