Mesenchymal Stromal Cells for Acute Graft Versus Host Disease

NCT ID: NCT01589549

Last Updated: 2015-06-09

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

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-04-30

Study Completion Date

2016-12-31

Brief Summary

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A randomised study of corticosteroid therapy with or without mesenchymal stromal cell therapy for newly diagnosed acute graft versus host disease after bone marrow transplantation or donor lymphocyte therapy.

It is hypothesised that mesenchymal stromal cell therapy will be superior

Detailed Description

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Patients with newly diagnosed untreated acute graft versus host disease grades 2-4 will receive methylprednisolone 2.5mg/kg intravenously and randomised to receive or not receive allogeneic human mesenchymal stromal cells 2X10E6 intravenously on two occasions at weekly intervals

Conditions

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Acute GVH Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Mesenchymal stromal cell therapy

Mesenchymal stromal cell therapy in addition to corticosteroid therapy

Group Type EXPERIMENTAL

Mesenchymal stromal cell therapy

Intervention Type BIOLOGICAL

One arm will be randomised to receive mesenchymal stromal cell therapy in addition to corticosteroid therapy

Corticosteroid therapy

Group Type ACTIVE_COMPARATOR

Mesenchymal stromal cell therapy

Intervention Type BIOLOGICAL

One arm will be randomised to receive mesenchymal stromal cell therapy in addition to corticosteroid therapy

Interventions

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Mesenchymal stromal cell therapy

One arm will be randomised to receive mesenchymal stromal cell therapy in addition to corticosteroid therapy

Intervention Type BIOLOGICAL

Other Intervention Names

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Methylprednisolone Mesenchymal stem cells

Eligibility Criteria

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Inclusion Criteria

* Grades 2-4 acute graft versus host disease after bone marrow transplantation up to day +180 after transplantation
* Age 18-55 years

* Must be receiving a calcineurin inhibitor

Exclusion Criteria

* Failure to sign informed consent
* Corticosteroid therapy for 72 hours or greater
* ECOG score equal to or greater than 3
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Royal Perth Hospital

OTHER

Sponsor Role collaborator

R.P.Herrmann

OTHER

Sponsor Role lead

Responsible Party

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R.P.Herrmann

Director, Cell and Tissue Therapies, Royal Perth Hospital

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Duncan Purtill, MB, BS

Role: PRINCIPAL_INVESTIGATOR

Royal Perth Hospital

Locations

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Royal Perth Hospital

Perth, Western Australia, Australia

Site Status RECRUITING

Countries

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Australia

Central Contacts

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Duncan Purtill, MB, BS

Role: CONTACT

+61 8 61523788

Richard Herrmann, MB, BS

Role: CONTACT

+61 8 92241987

Facility Contacts

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Megan Margaria, BN

Role: primary

+61 8 92247038

Other Identifiers

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CTN 2012/0174

Identifier Type: OTHER

Identifier Source: secondary_id

2011/128

Identifier Type: -

Identifier Source: org_study_id

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