Study Stopped
New requirements for study approval with the Swedish Medical Products Agency
Mesenchymal Stromal Cells as Treatment of Chronic Graft-versus-host Disease
1 other identifier
interventional
11
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Aug 2011
Longer than P75 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2011
CompletedFirst Submitted
Initial submission to the registry
January 24, 2012
CompletedFirst Posted
Study publicly available on registry
February 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2017
CompletedNovember 25, 2020
November 1, 2020
4.6 years
January 24, 2012
November 23, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
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.
Baseline to 9 months
Secondary Outcomes (4)
Change in disease activity as measured by histological examination
Baseline to 9 months
Change in self-assessed disease activity and quality of life
Baseline to 9 months
Safety (Adverse events, infections and relapse)
21 months
Freedom from steroids at 1 year after MSC treatment
1 year after finishing treatment
Study Arms (1)
Mesenchymal stromal cell treatment
EXPERIMENTALInterventions
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 Criteria
You may qualify if:
- 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
You may not qualify if:
- Active malignancy
- Fulfilling criteria for previously initiated study for treatment of chronic graft-versus-host disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Karolinska Institutetlead
- Region Stockholmcollaborator
Study Sites (1)
Hematology Center, Karolinska University Hospital Huddinge
Stockholm, Sweden
Related Publications (1)
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.
PMID: 32573983DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Leg läkare
Study Record Dates
First Submitted
January 24, 2012
First Posted
February 1, 2012
Study Start
August 1, 2011
Primary Completion
March 1, 2016
Study Completion
March 1, 2017
Last Updated
November 25, 2020
Record last verified: 2020-11