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

This study is ongoing, but not recruiting participants.

Sponsor:

Collaborator:

Stockholm County Council, Sweden

Information provided by (Responsible Party):

Lena von Bahr, Karolinska Institutet

ClinicalTrials.gov Identifier:

NCT01522716

First received: January 24, 2012

Last updated: May 30, 2016

Last verified: May 2016

History of Changes

Purpose

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.

Condition	Intervention	Phase
Graft-Versus-Host Disease	Biological: Mesenchymal stromal cells	Phase 1


Study Type:	Interventional
Study Design:	Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Mesenchymal Stromal Cells as Treatment of Chronic Graft-versus-host Disease

Resource links provided by NLM:

Genetic and Rare Diseases Information Center resources: Homologous Wasting Disease Chronic Graft Versus Host Disease

U.S. FDA Resources

Further study details as provided by Lena von Bahr, Karolinska Institutet:

Primary Outcome Measures:

Change in disease activity according to National Institute of Health criteria [ Time Frame: Baseline to 9 months ]

Secondary Outcome Measures:

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 ]
Frequency of complications, infections and relapse
Freedom from steroids at 1 year after MSC treatment [ Time Frame: 1 year after finishing treatment ]
Proportion of patients free from corticosteroids at 1 year after finishing MSC treatment.


Enrollment:	11
Study Start Date:	August 2011
Estimated Study Completion Date:	March 2017
Primary Completion Date:	March 2016 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Mesenchymal stromal cell treatment	Biological: 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.

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01522716

Locations


Sweden
Hematology Center, Karolinska University Hospital Huddinge
Stockholm, Sweden

Sponsors and Collaborators

Karolinska Institutet

Stockholm County Council, Sweden

More Information


Responsible Party:	Lena von Bahr, Leg läkare, Karolinska Institutet
ClinicalTrials.gov Identifier:	NCT01522716 History of Changes
Other Study ID Numbers:	MSC-cGVH
Study First Received:	January 24, 2012
Last Updated:	May 30, 2016

Additional relevant MeSH terms:


Graft vs Host Disease Immune System Diseases

ClinicalTrials.gov processed this record on July 19, 2017

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