Mesenchymal Stromal Cells as Treatment of Chronic Graft-versus-host Disease

Karolinska Institute

Status and phase: Terminated; Phase 1

Conditions: Graft-Versus-Host Disease

Treatments: Biological: Mesenchymal stromal cells

Study type: Interventional

Funder types: Other

Identifiers

NCT01522716

MSC-cGVH

Details and patient eligibility

About

The aim of the study is to evaluate the safety and efficacy of mesenchymal stromal cells as treatment for steroid-refractory chronic graft-versus-host disease.

Enrollment: 11 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Chronic graft-versus-host disease, grade moderate or severe despite at least 3 months treatment with calcineurin inhibitors and steroids OR
• Chronic graft-versus-host disease, grade moderate or severe, where full treatment with calcineurin inhibitors and steroids is impossible due to intolerable side-effects

Exclusion criteria

• Active malignancy
• Fulfilling criteria for previously initiated study for treatment of chronic graft-versus-host disease

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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11 participants in 1 patient group

Mesenchymal stromal cell treatment

Experimental group

Treatment:

Biological: Mesenchymal stromal cells