A Phase 1 interventional study of Autologous mesenchymal stem cells in Autologous Mesenchymal Stem Cells and Multiple Sclerosis, sponsored by Karolinska Institutet. Completed at 2 sites in Sweden. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2023-06-01.
Sponsored by Karolinska Institutet · Phase 1, Interventional, and Treatment
To assess the safety of a single dose of IV infusion of bone-marrow derived autologous Mesenchymal Stem Cells (MSCs) in Multiple Sclerosis (MS) with progressive disease status.
3,460 studies on the registry are indexed under Multiple Sclerosis; 661 are open to participants now.
This study's enrollment of 7 is below the median of 50 across 2,342 interventional studies indexed under Multiple Sclerosis.
Browse Multiple Sclerosis studies →Karolinska Institutet is the lead sponsor of 1,113 studies on the registry; 267 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Diagnosis of MS
Exclusion Criteria:
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.
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.
Time frame: 48 weeks
To evaluate effects on MS disease activity measured by cumulative number of MRI T2 lesions.
Brain MRI examination
Time frame: 48 weeks
To evaluate effects on MS disease activity measured by change in EDSS (expanded disability status scale).
EDSS assessed by neurologist.
Time frame: 48 weeks
To evaluate effect on peripheral blood immune cell populations.
Peripheral blood samples.
Time frame: 24 weeks
This study is completed, as verified in May 2023. You cannot join it, but the record below documents what was studied.
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Karolinska Institutet