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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Open label single arm study | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Autologous mesenchymal stem cells | Biological | IV therapy with autologous bone-marrow derived mesenchymal stem cells |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 48 weeks |
| To evaluate effects on MS disease activity measured by cumulative number of MRI T2 lesions. | Brain MRI examination | 48 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate effects on MS disease activity measured by change in EDSS (expanded disability status scale). | EDSS assessed by neurologist. | 48 weeks |
| To evaluate effect on peripheral blood immune cell populations. |
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Inclusion Criteria:
Diagnosis of MS
Age_ 18-65 years
Disease duration: 2-20 years
EDSS 3,0-7,0
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Karolinska Institute, Karolinska University Hospital Solna | Stockholm | 171 76 | Sweden | |||
| Karolinska Institute, Karolinska University Hospital |
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| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
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Open-label phase 1, single-center, pre-post comparison study
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Peripheral blood samples.
| 24 weeks |
| Stockholm |
| 17176 |
| Sweden |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |