Mesenchymal Stromal Cells for Acute Graft Versus Host Disease

June 8, 2015 updated by: R.P.Herrmann

A Phase 2 Trial of Standard of Care Treatment Versus Mesenchymal Stromal Cell Therapy Together With Standard of Care for the Treatment of de Novo Acute Graft Versus Host Disease Following Allogeneic Bone Marrow Transplantation

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Anticipated)

66

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

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

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Mesenchymal stromal cell therapy
Mesenchymal stromal cell therapy in addition to corticosteroid therapy
Biological: Mesenchymal stromal cell therapy
One arm will be randomised to receive mesenchymal stromal cell therapy in addition to corticosteroid therapy
Other Names:
  • Methylprednisolone
  • Mesenchymal stem cells
Active Comparator: Corticosteroid therapy
Biological: Mesenchymal stromal cell therapy
One arm will be randomised to receive mesenchymal stromal cell therapy in addition to corticosteroid therapy
Other Names:
  • Methylprednisolone
  • Mesenchymal stem cells

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Survival at one year after onset of graft versus host disease
Time Frame: One year
One year

Secondary Outcome Measures

Outcome Measure
Time Frame
Response at 14 days after commencement of treatment for acute graft versus host disease
Time Frame: 14 days
14 days
Response at 28 days after commencement of treatment of acute graft versus host disease
Time Frame: 28 days
28 days
Incidence of severe infection
Time Frame: One year
One year
Disease free survival at one year
Time Frame: One year
One year
Time to treatment failure, requiring salvage therapy
Time Frame: 28 days
28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

R.P.Herrmann

Collaborators

Royal Perth Hospital

Investigators

  • Principal Investigator: Duncan Purtill, MB, BS, Royal Perth Hospital

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

April 1, 2012

Primary Completion (Anticipated)

December 1, 2015

Study Completion (Anticipated)

December 1, 2016

Study Registration Dates

First Submitted

April 26, 2012

First Submitted That Met QC Criteria

April 30, 2012

First Posted (Estimate)

May 2, 2012

Study Record Updates

Last Update Posted (Estimate)

June 9, 2015

Last Update Submitted That Met QC Criteria

June 8, 2015

Last Verified

June 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2011/128
  • CTN 2012/0174 (Other Identifier: Therapeutics Goods Administration, Government of Australia)

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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