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

Karolinska Institutet1 site in 1 country11 target enrollmentAugust 2011

ConditionsGraft-Versus-Host Disease

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Graft-Versus-Host Disease
Sponsor: Karolinska Institutet
Enrollment: 11
Locations: 1
Primary Endpoint: Change in disease activity according to National Institute of Health criteria
Status: Terminated
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

August 2011

End Date

March 2017

Last Updated

5 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Karolinska Institutet

Responsible Party

Principal Investigator

Lena von Bahr

Leg läkare

Karolinska Institutet

Eligibility Criteria

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

Outcomes

Primary Outcomes

Change in disease activity according to National Institute of Health criteria

Time Frame: Baseline to 9 months

Patients are evaluated according to NIH criteria at 3, 6 and (if applicable) 9 months after initialising MSC treatment, and the score compared to baseline score.

Secondary Outcomes

Change in self-assessed disease activity and quality of life(Baseline to 9 months)
Change in disease activity as measured by histological examination(Baseline to 9 months)
Freedom from steroids at 1 year after MSC treatment(1 year after finishing treatment)
Safety (Adverse events, infections and relapse)(21 months)