Mesenchymal Stromal Cells for Acute Graft Versus Host Disease

Acute GVH Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01589549
• Other study ID #: 2011/128
• Secondary ID: CTN 2012/0174
• Status: Recruiting
• Phase: Phase 2
• First received: April 26, 2012
• Last updated: June 8, 2015
• Start date: April 2012
• Est. completion date: December 2016

Study information

• Verified date: June 2015
• Source: Royal Perth Hospital
• Contact: Duncan Purtill, MB, BS
• Phone: +61 8 61523788
• Email: duncan.purtill[@]health.gov.au
• Is FDA regulated: No
• Health authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 66
• Est. completion date: December 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute GVH Disease
• Graft vs Host Disease

Intervention

Biological:
• Mesenchymal stromal cell therapy
One arm will be randomised to receive mesenchymal stromal cell therapy in addition to corticosteroid therapy

Locations

Country	Name	City	State
Australia	Royal Perth Hospital	Perth	Western Australia

Sponsors (2)

Lead Sponsor	Collaborator
R.P.Herrmann	Royal Perth Hospital

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survival at one year after onset of graft versus host disease		One year	Yes
Secondary	Response at 14 days after commencement of treatment for acute graft versus host disease		14 days	No
Secondary	Response at 28 days after commencement of treatment of acute graft versus host disease		28 days	No
Secondary	Incidence of severe infection		One year	Yes
Secondary	Disease free survival at one year		One year	Yes
Secondary	Time to treatment failure, requiring salvage therapy		28 days	Yes