Mesenchymal Stromal Cells for Acute Graft Versus Host Disease

Phase 2

• Conditions: Acute GVH Disease
• Interventions: Biological: Mesenchymal stromal cell therapy

• Registration Number: NCT01589549
• Lead Sponsor: R.P.Herrmann

Brief Summary

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

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 Timeline

• Study Start: 2012-04
• Study First Submitted: 2012-04-26
• Study First Submitted QC: 2012-04-30
• Study First Posted: 2012-05-02
• Status Verified: 2015-06
• Last Update Submitted: 2015-06-08
• Last Update Posted: 2015-06-09
• Primary Completion: 2015-12
• Study Completion: 2016-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 66

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mesenchymal stromal cell therapy	Mesenchymal stromal cell therapy	Mesenchymal stromal cell therapy in addition to corticosteroid therapy
Corticosteroid therapy	Mesenchymal stromal cell therapy	-

Primary Outcome Measures

Name	Time	Method
Survival at one year after onset of graft versus host disease	One year

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Royal Perth Hospital; 🇦🇺 Perth, Western Australia, Australia