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

NCT ID: NCT02174536

Last Updated: 2014-06-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-03-31

Study Completion Date

2016-12-31

Brief Summary

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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

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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.

Conditions

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Hemorrhagic Cystitis Stem Cell Transplantation Decidual Stromal Cells

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Decidual stromal cells

Intervention Type BIOLOGICAL

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

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).

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type BIOLOGICAL

Interventions

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Decidual stromal cells

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

Intervention Type BIOLOGICAL

Placebo

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Hemorrhagic cystitis grade 2-4
* Receives Misoprostol therapy

Exclusion Criteria

* Patients with urinary urge without macroscopic hematuria or clots
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Karolinska Institutet

OTHER

Sponsor Role lead

Responsible Party

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Olle Ringdén

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Olle Ringdén, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Karolinska Institutet

Locations

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Karolinska Institutet

Stockholm, Stockholm County, Sweden

Site Status RECRUITING

Countries

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Sweden

Central Contacts

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Olle Ringdén, MD, PhD

Role: CONTACT

+46858582672

Helen Kaipe, PhD

Role: CONTACT

+46700901052

Facility Contacts

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Olle Ringdén, MD, PhD

Role: primary

+46858582672

Other Identifiers

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DSCHC002

Identifier Type: -

Identifier Source: org_study_id

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