A Double Blind Randomized Study Using Placenta Derived Decidual Stromal Cells for Hemorrhagic Cystitis

June 24, 2014 updated by: Olle Ringdén, Karolinska Institutet
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Stockholm, Sweden, 14186
        • Recruiting
        • Karolinska Institutet
        • Contact:
        • Principal Investigator:
          • Olle Ringdén, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Hemorrhagic cystitis grade 2-4
  • Receives Misoprostol therapy

Exclusion Criteria:

  • Patients with urinary urge without macroscopic hematuria or clots

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 month after inclusion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to disappearance of pain or urges
Time Frame: 1 month after inclusion
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.
1 month after inclusion
Transplant related mortality
Time Frame: 1 year after inclusion
All mortality except relapse
1 year after inclusion
Incidence of severe infections
Time Frame: 1 year after inclusion
Incidence of severe bacterial, viral or fungal infections.
1 year after inclusion
Incidence of graft versus host disease
Time Frame: One year after inclusion
One year after inclusion
Overall actuarial survival
Time Frame: Actuarial
Actuarial

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Karolinska Institutet

Investigators

  • Principal Investigator: Olle Ringdén, MD, PhD, Karolinska Institutet

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2014

Primary Completion (Anticipated)

December 1, 2016

Study Completion (Anticipated)

December 1, 2016

Study Registration Dates

First Submitted

June 23, 2014

First Submitted That Met QC Criteria

June 24, 2014

First Posted (Estimate)

June 25, 2014

Study Record Updates

Last Update Posted (Estimate)

June 25, 2014

Last Update Submitted That Met QC Criteria

June 24, 2014

Last Verified

June 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DSCHC002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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