Back to resultsMesenchymal Stromal Cells as Treatment of Chronic Graft-versus-host Disease
Primary Purpose
Graft-Versus-Host Disease
Status
Terminated
Phase
Phase 1
Locations
Sweden
Study Type
Interventional
Intervention
Mesenchymal stromal cells
Sponsored by
About this trial
This is an interventional treatment trial for Graft-Versus-Host Disease
Eligibility 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
Sites / Locations
- Hematology Center, Karolinska University Hospital Huddinge
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Mesenchymal stromal cell treatment
Arm Description
Outcomes
Primary Outcome Measures
Change in disease activity according to National Institute of Health criteria
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
Change in disease activity as measured by histological examination
Change in self-assessed disease activity and quality of life
Safety (Adverse events, infections and relapse)
Frequency of complications, infections and relapse
Freedom from steroids at 1 year after MSC treatment
Proportion of patients free from corticosteroids at 1 year after finishing MSC treatment.
Full Information
NCT ID
NCT01522716
First Posted
January 24, 2012
Last Updated
November 23, 2020
Sponsor
Karolinska Institutet
Collaborators
Region Stockholm
1. Study Identification
Unique Protocol Identification Number
NCT01522716
Brief Title
Mesenchymal Stromal Cells as Treatment of Chronic Graft-versus-host Disease
Official Title
Mesenchymal Stromal Cells as Treatment of Chronic Graft-versus-host Disease
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Terminated
Why Stopped
New requirements for study approval with the Swedish Medical Products Agency
Study Start Date
August 2011 (undefined)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
March 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska Institutet
Collaborators
Region Stockholm
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Graft-Versus-Host Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
11 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Mesenchymal stromal cell treatment
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
Mesenchymal stromal cells
Intervention Description
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 Outcome Measure Information:
Title
Change in disease activity according to National Institute of Health criteria
Description
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.
Time Frame
Baseline to 9 months
Secondary Outcome Measure Information:
Title
Change in disease activity as measured by histological examination
Time Frame
Baseline to 9 months
Title
Change in self-assessed disease activity and quality of life
Time Frame
Baseline to 9 months
Title
Safety (Adverse events, infections and relapse)
Description
Frequency of complications, infections and relapse
Time Frame
21 months
Title
Freedom from steroids at 1 year after MSC treatment
Description
Proportion of patients free from corticosteroids at 1 year after finishing MSC treatment.
Time Frame
1 year after finishing treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Hematology Center, Karolinska University Hospital Huddinge
City
Stockholm
Country
Sweden
12. IPD Sharing Statement
Citations:
PubMed Identifier
32573983
Citation
Boberg E, von Bahr L, Afram G, Lindstrom C, Ljungman P, Heldring N, Petzelbauer P, Garming Legert K, Kadri N, Le Blanc K. Treatment of chronic GvHD with mesenchymal stromal cells induces durable responses: A phase II study. Stem Cells Transl Med. 2020 Oct;9(10):1190-1202. doi: 10.1002/sctm.20-0099. Epub 2020 Jun 23.
Results Reference
derived
Learn more about this trial
Mesenchymal Stromal Cells as Treatment of Chronic Graft-versus-host Disease
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