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

NCT ID: NCT02172963

Last Updated: 2014-06-24

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

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-11-30

Study Completion Date

2013-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Hemorrhagic Cystitis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Decidual Stromal Cell therapy for Hemorrhagic Cystitis

Group Type EXPERIMENTAL

Decidual Stromal Cell therapy

Intervention Type BIOLOGICAL

Intravenous injection with placenta derived Decidual Stromal Cells. 1-2x10\^6 cells/kg.

Interventions

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Decidual Stromal Cell therapy

Intravenous injection with placenta derived Decidual Stromal Cells. 1-2x10\^6 cells/kg.

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Hemorrhagic cystitis grade 2-4

Exclusion Criteria

* 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, , Sweden

Site Status

Countries

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Sweden

Other Identifiers

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DSCHC001

Identifier Type: -

Identifier Source: org_study_id

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