Autologous Mesenchymal Stem Cells, Multiple Sclerosis
Conditions
Keywords
Mesenchymal Stem Cells, Multiple Sclerosis
Brief summary
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.
Interventions
BIOLOGICALAutologous mesenchymal stem cells
IV therapy with autologous bone-marrow derived mesenchymal stem cells
Sponsors
Karolinska Institutet
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Open-label phase 1, single-center, pre-post comparison study
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Diagnosis of MS 1. Active relapsing remitting MS (RRMS) as evidenced by presence of ≥ 1 clinically documented relapse in the past 12 months or ≥2 clinically documented relapses in the last 24 months. 2. Secondary progressive MS with clinical progression as evidenced by an increase of 1 EDSS point (or 0,5 p if EDSS ≥ 5 at time for study start) in the last year or evidenced by ≥1 relapse or ≥ GEL at MRI performed within the last year. 3. Primary progressive MS with clinical progression as evidenced by an increase of 1 EDSS point (or 0,5 p if EDSS ≥ 5 at time for study start) in the last year. 2. Age\_ 18-65 years 3. Disease duration: 2-20 years 4. EDSS 3,0-7,0
Exclusion criteria
1. Subtype of MS not fulfilling inclusion criteria 2. Treatment with any immunosuppressive therapy, including natalizumab and fingolimod, within the 3 months prior to randomization 3. Treatment with interferon-beta or glatiramer acetate within the 30 days prior to randomization 4. Treatment with corticosteroids within the 30 days prior to randomization 5. Relapse occurred during the 60 days prior to randomization 6. Previous history of a malignancy other than basal cell carcinoma of the skin or carcinoma in situ that has been in remission for more than one year 7. Severely limited life expectancy by another co-morbid illness 8. Active or chronic severe infection. 9. History of previous diagnosis of myelodysplasia or previous hematologic disease or current clinically relevant abnormalities of white blood cell counts 10. Pregnancy or risk or pregnancy (this includes patients that are unwilling to practice active contraception during the duration of the study) 11. eGFR \< 60 mL/min/1.73m2 or known renal failure or inability to undergo MRI examination. 12. Inability to give written informed consent in accordance with research ethics board guidelines
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To evaluate number of participants with an adverse event related to the treatment. | 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. | 48 weeks | Brain MRI examination |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To evaluate effects on MS disease activity measured by change in EDSS (expanded disability status scale). | 48 weeks | EDSS assessed by neurologist. |
| To evaluate effect on peripheral blood immune cell populations. | 24 weeks | Peripheral blood samples. |
Countries
Sweden
Outcome results
None listed