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

Primary Purpose

Hemorrhagic Cystitis, Stem Cell Transplantation, Decidual Stromal Cells

Status

Unknown status

Phase

Phase 2

Locations

Sweden

Study Type

Interventional

Intervention

Decidual stromal cells

Placebo

About this trial

This is an interventional treatment trial for Hemorrhagic Cystitis

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Hemorrhagic cystitis grade 2-4
Receives Misoprostol therapy

Exclusion Criteria:

Patients with urinary urge without macroscopic hematuria or clots

Sites / Locations

Karolinska InstitutetRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Decidual Stromal cell therapy

Placebo

Arm Description

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.

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).

Outcomes

Primary Outcome Measures

Days to disappearence of macroscopic hematuria or clots

Each day, patients fill out a form were they state whether they have macroscopic hematuria or not.

Secondary Outcome Measures

Time to disappearance of pain or urges

Time to disappearance of microscopic hematuria

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

All mortality except relapse

Incidence of severe infections

Incidence of severe bacterial, viral or fungal infections.

Incidence of graft versus host disease

Overall actuarial survival

Full Information

NCT ID

NCT02174536

First Posted

June 23, 2014

Last Updated

June 24, 2014

Sponsor

Karolinska Institutet

1. Study Identification

Unique Protocol Identification Number

NCT02174536

Brief Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2014

Overall Recruitment Status

Unknown status

Study Start Date

March 2014 (undefined)

Primary Completion Date

December 2016 (Anticipated)

Study Completion Date

December 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Karolinska Institutet

4. Oversight

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hemorrhagic Cystitis, Stem Cell Transplantation, Decidual Stromal Cells

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Decidual Stromal cell therapy

Arm Type

Active Comparator

Arm Description

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.

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

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).

Intervention Type

Biological

Intervention Name(s)

Decidual stromal cells

Intervention Description

Decidual stromal cells (approximately 1x10^6 cells/kg) will be infused intravenously.

Intervention Type

Biological

Intervention Name(s)

Placebo

Primary Outcome Measure Information:

Title

Days to disappearence of macroscopic hematuria or clots

Description

Each day, patients fill out a form were they state whether they have macroscopic hematuria or not.

Time Frame

1 month after inclusion

Secondary Outcome Measure Information:

Title

Time to disappearance of pain or urges

Time Frame

1 month after inclusion

Title

Time to disappearance of microscopic hematuria

Description

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.

Time Frame

1 month after inclusion

Title

Transplant related mortality

Description

All mortality except relapse

Time Frame

1 year after inclusion

Title

Incidence of severe infections

Description

Incidence of severe bacterial, viral or fungal infections.

Time Frame

1 year after inclusion

Title

Incidence of graft versus host disease

Time Frame

One year after inclusion

Title

Overall actuarial survival

Time Frame

Actuarial

10. Eligibility

Sex

All

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Hemorrhagic cystitis grade 2-4 Receives Misoprostol therapy Exclusion Criteria: Patients with urinary urge without macroscopic hematuria or clots

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Olle Ringdén, MD, PhD

Phone

+46858582672

olle.ringden@ki.se

First Name & Middle Initial & Last Name or Official Title & Degree

Helen Kaipe, PhD

Phone

+46700901052

helen.kaipe@ki.se

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Olle Ringdén, MD, PhD

Organizational Affiliation

Karolinska Institutet

Official's Role

Principal Investigator

Facility Information:

Facility Name

Karolinska Institutet

City

Stockholm

ZIP/Postal Code

14186

Country

Sweden

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Olle Ringdén, MD, PhD

Phone

+46858582672

olle.ringden@ki.se

First Name & Middle Initial & Last Name & Degree

Olle Ringdén, MD, PhD

12. IPD Sharing Statement

Learn more about this trial

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

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