Clinical trial NCT03778333: Mesenchymal Stem Cells for Progressive Multiple Sclerosis_Sweden
Official title: Mesenchymal Stem Cells for Progressive Multiple Sclerosis_Sweden
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Autologous Mesenchymal Stem Cells
Multiple Sclerosis
Keywords: Mesenchymal Stem Cells
Multiple Sclerosis
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2018-12-19
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Open-label phase 1, single-center, pre-post comparison study
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: To evaluate number of participants with an adverse event related to the treatment.
timeFrame: 48 weeks
measure: To evaluate effects on MS disease activity measured by cumulative number of MRI T2 lesions.
timeFrame: 48 weeks
Secondary outcomes:
measure: To evaluate effects on MS disease activity measured by change in EDSS (expanded disability status scale).
timeFrame: 48 weeks
measure: To evaluate effect on peripheral blood immune cell populations.
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Karolinska Institute, Karolinska University Hospital Solna
city: Stockholm
country: Sweden
facility: Karolinska Institute, Karolinska University Hospital
Study officials:
References: