Mesenchymal Stromal Cells for Acute Graft Versus Host Disease

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

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01589549

Enrollment

Registered

2012-05-02

Start date

2012-04-30

Completion date

2016-12-31

Last updated

2015-06-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute GVH Disease

Keywords

Acute graft versus host disease, Bone marrow transplantation, Mesenchymal stromal cells

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

Interventions

BIOLOGICALMesenchymal stromal cell therapy

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Survival at one year after onset of graft versus host disease	One year

Secondary

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

Countries

Australia

Contacts

Primary ContactDuncan Purtill, MB, BS

duncan.purtill@health.gov.au+61 8 61523788

Backup ContactRichard Herrmann, MB, BS

richard.herrmann@health.wa.gov.au+61 8 92241987

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026