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

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ClinicalTrials.gov Identifier: NCT01522716
Recruitment Status : Terminated (New requirements for study approval with the Swedish Medical Products Agency)
First Posted : February 1, 2012
Last Update Posted : November 25, 2020
Sponsor:
Collaborator:
Stockholm County Council, Sweden
Information provided by (Responsible Party):
Lena von Bahr, Karolinska Institutet

Study Description
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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.

Condition or disease Intervention/treatment Phase
Graft-Versus-Host Disease Biological: Mesenchymal stromal cells Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Mesenchymal Stromal Cells as Treatment of Chronic Graft-versus-host Disease
Study Start Date : August 2011
Actual Primary Completion Date : March 2016
Actual Study Completion Date : March 2017

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Arms and Interventions
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Arm Intervention/treatment
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.


Outcome Measures
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Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Change in disease activity as measured by histological examination [ Time Frame: Baseline to 9 months ]
  2. Change in self-assessed disease activity and quality of life [ Time Frame: Baseline to 9 months ]
  3. Safety (Adverse events, infections and relapse) [ Time Frame: 21 months ]
    Frequency of complications, infections and relapse

  4. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01522716


Locations
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Sweden
Hematology Center, Karolinska University Hospital Huddinge
Stockholm, Sweden
Sponsors and Collaborators
Karolinska Institutet
Stockholm County Council, Sweden
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Lena von Bahr, Leg läkare, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT01522716    
Other Study ID Numbers: MSC-cGVH
First Posted: February 1, 2012    Key Record Dates
Last Update Posted: November 25, 2020
Last Verified: November 2020
Additional relevant MeSH terms:
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Graft vs Host Disease
Immune System Diseases