A Pilot Study Using Placenta Derived Decidual Stromal Cells for Hemorrhagic Cystitis

June 23, 2014 updated by: Olle Ringdén, Karolinska Institutet
The purpose of this study is to evaluate the safety and efficacy using placenta derived decidual stromal cell therapy for hemorrhagic cystitis after allogeneic hematopoietic cell transplantation. It is hypothesized that the decidual stromal cell therapy is safe to infuse and that they have a positive clinical effect.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Patients with grade 2-4 hemorrhagic cystitis will receive decidual stromal cell therapy at approximately 1-2x10^6 cells/kg once or at weekly intervals dependent on clinical effect.

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Phase 2
  • Phase 1

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
        • Karolinska Institutet

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

Exclusion Criteria:

  • 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: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Decidual Stromal Cell therapy for Hemorrhagic Cystitis
Biological: Decidual Stromal Cell therapy
Intravenous injection with placenta derived Decidual Stromal Cells. 1-2x10^6 cells/kg.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Response at day 28 after onset of hemorrhagic cystitis
Time Frame: 28 days after inclusion
Disappearance of macroscopic hematuria.
28 days after inclusion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Actuarial survival at one year after onset of hemorrhagic cystitis
Time Frame: One year after inclusion
One year after inclusion
Time to disappearance of pain or urges
Time Frame: Up to 6 months after inclusion
Up to 6 months after inclusion
Time to disappearance of microscopic hematuria
Time Frame: Up to 84 days after inclusion
Up to 84 days after inclusion
Transplant related mortality
Time Frame: Up to one year after inclusion
All mortality except for relapse
Up to one year after inclusion
Incidence of severe infections
Time Frame: Up to one year after inclusion
Incidence of severe bacterial, viral or fungal infections.
Up to one year after inclusion
Incidence of graft versus host disease
Time Frame: Up to one year after inclusion
Up to one year after inclusion

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

November 1, 2011

Primary Completion (Actual)

December 1, 2013

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

June 18, 2014

First Submitted That Met QC Criteria

June 23, 2014

First Posted (Estimate)

June 24, 2014

Study Record Updates

Last Update Posted (Estimate)

June 24, 2014

Last Update Submitted That Met QC Criteria

June 23, 2014

Last Verified

June 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DSCHC001

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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