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

Phase 1

Terminated

• Conditions: Graft-Versus-Host Disease
• Interventions: Biological: Mesenchymal stromal cells

• Registration Number: NCT01522716
• Lead Sponsor: Karolinska Institutet

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-08
• Study First Submitted: 2012-01-24
• Study First Submitted QC: 2012-01-27
• Study First Posted: 2012-02-01
• Primary Completion: 2016-03
• Study Completion: 2017-03
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-23
• Last Update Posted: 2020-11-25

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 11

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Mesenchymal stromal cell treatment	Mesenchymal stromal cells	-

Primary Outcome Measures

Name	Time	Method
Change in disease activity according to National Institute of Health criteria	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 Outcome Measures

Name	Time	Method
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	Proportion of patients free from corticosteroids at 1 year after finishing MSC treatment.
Safety (Adverse events, infections and relapse)	21 months	Frequency of complications, infections and relapse

Trial Locations

Locations (1)

Hematology Center, Karolinska University Hospital Huddinge; 🇸🇪 Stockholm, Sweden