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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: Endpoint Classification: Safety/Efficacy Study
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:

U.S. FDA Resources

Further study details as provided by Karolinska Institutet:

Primary Outcome Measures:
  • Change in disease activity according to National Institute of Health criteria [ Time Frame: Baseline to 9 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in disease activity as measured by histological examination [ Time Frame: Baseline to 9 months ] [ Designated as safety issue: No ]
  • Change in self-assessed disease activity and quality of life [ Time Frame: Baseline to 9 months ] [ Designated as safety issue: No ]
  • Safety [ Time Frame: 21 months ] [ Designated as safety issue: Yes ]
    Frequency of complications, infections and relapse

  • Freedom from steroids at 1 year after MSC treatment [ Time Frame: 1 year after finishing treatment ] [ Designated as safety issue: No ]
    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)
Genders Eligible for Study:   Both
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
Health Authority: Sweden: The National Board of Health and Welfare
Sweden: Regional Ethical Review Board

Additional relevant MeSH terms:
Graft vs Host Disease
Immune System Diseases

ClinicalTrials.gov processed this record on September 29, 2016