Mesenchymal Stromal Cells as Treatment of Chronic Graft-versus-host Disease
NCT ID: NCT01522716
Last Updated: 2020-11-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE1
11 participants
INTERVENTIONAL
2011-08-31
2017-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Mesenchymal stromal cell treatment
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.
Interventions
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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 Criteria
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Inclusion Criteria
* 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
* Fulfilling criteria for previously initiated study for treatment of chronic graft-versus-host disease
18 Years
ALL
No
Sponsors
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Region Stockholm
OTHER_GOV
Karolinska Institutet
OTHER
Responsible Party
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Lena von Bahr
Leg läkare
Locations
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Hematology Center, Karolinska University Hospital Huddinge
Stockholm, , Sweden
Countries
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References
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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.
Other Identifiers
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MSC-cGVH
Identifier Type: -
Identifier Source: org_study_id