Overview

This trial is active, not recruiting.

Condition graft-versus-host disease
Treatment mesenchymal stromal cells
Phase phase 1
Sponsor Karolinska Institutet
Collaborator Stockholm County Council, Sweden
Start date August 2011
End date March 2016
Trial size 11 participants
Trial identifier NCT01522716, MSC-cGVH

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
mesenchymal stromal cells
Allogenous mesenchymal stromal cells, to be injected intravenously at a dose of 1-2 million/kg at a frequency of once a month (frequency may be changed during the study if deemed appropriate by investigators) for 6-9 months.

Primary Outcomes

Measure
Change in disease activity according to National Institute of Health criteria
time frame: Baseline to 9 months

Secondary Outcomes

Measure
Change in disease activity as measured by histological examination
time frame: Baseline to 9 months
Change in self-assessed disease activity and quality of life
time frame: Baseline to 9 months
Safety
time frame: 21 months
Freedom from steroids at 1 year after MSC treatment
time frame: 1 year after finishing treatment

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Mesenchymal Stromal Cells as Treatment of Chronic Graft-versus-host Disease
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by Karolinska Institutet.