Mesenchymal Stromal Cells for Acute Graft Versus Host Disease

R.P.Herrmann

Status and phase: Unknown; Phase 2

Conditions: Acute GVH Disease

Treatments: Biological: Mesenchymal stromal cell therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT01589549

2011/128

CTN 2012/0174 (Other Identifier)

Details and patient eligibility

About

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

Full 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

Enrollment: 66 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

66 participants in 2 patient groups

Mesenchymal stromal cell therapy

Experimental group

Description:

Mesenchymal stromal cell therapy in addition to corticosteroid therapy

Treatment:

Biological: Mesenchymal stromal cell therapy

Corticosteroid therapy

Active Comparator group

Treatment:

Biological: Mesenchymal stromal cell therapy