Mesenchymal Stem Cells for Progressive Multiple Sclerosis_Sweden
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|ClinicalTrials.gov Identifier: NCT03778333|
Recruitment Status : Completed
First Posted : December 18, 2018
Last Update Posted : December 18, 2018
|Condition or disease||Intervention/treatment||Phase|
|Autologous Mesenchymal Stem Cells Multiple Sclerosis||Biological: Autologous mesenchymal stem cells||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||7 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Open-label phase 1, single-center, pre-post comparison study|
|Masking:||None (Open Label)|
|Official Title:||Mesenchymal Stem Cells for Progressive Multiple Sclerosis_Sweden|
|Actual Study Start Date :||December 1, 2012|
|Actual Primary Completion Date :||December 2016|
|Actual Study Completion Date :||December 31, 2016|
Experimental: Open label single arm study
All patients will be treated with 1 single dose of IV infusion of autologous bone-marrow derived mesenchymal stem cells (1-2 million cells/kg body weight) and their therapeutic response will be followed over 48 weeks.
Biological: Autologous mesenchymal stem cells
IV therapy with autologous bone-marrow derived mesenchymal stem cells
- To evaluate number of participants with an adverse event related to the treatment. [ Time Frame: 48 weeks ]Adverse events is defined as any untoward or undesirable medical occurence in the form of signs, symptoms, abnormal findings or diseases that emerge during the study period, regardless of causal relationship to the study drug.
- To evaluate effects on MS disease activity measured by cumulative number of MRI T2 lesions. [ Time Frame: 48 weeks ]Brain MRI examination
- To evaluate effects on MS disease activity measured by change in EDSS (expanded disability status scale). [ Time Frame: 48 weeks ]EDSS assessed by neurologist.
- To evaluate effect on peripheral blood immune cell populations. [ Time Frame: 24 weeks ]Peripheral blood samples.
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): NCT03778333
|Karolinska Institute, Karolinska University Hospital Solna|
|Stockholm, Sweden, 171 76|
|Karolinska Institute, Karolinska University Hospital|
|Stockholm, Sweden, 17176|