Mesenchymal Stem Cells for Progressive Multiple Sclerosis_Sweden

Karolinska Institutet2 sites in 1 country7 target enrollmentDecember 1, 2012

ConditionsAutologous Mesenchymal Stem Cells Multiple Sclerosis

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Autologous Mesenchymal Stem Cells
Sponsor: Karolinska Institutet
Enrollment: 7
Locations: 2
Primary Endpoint: To evaluate number of participants with an adverse event related to the treatment.
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

December 1, 2012

End Date

December 31, 2016

Last Updated

2 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Karolinska Institutet

Responsible Party

Principal Investigator

Lou Brundin

MD, PhD

Karolinska Institutet

Eligibility Criteria

Inclusion Criteria

•Diagnosis of MS
•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.
•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.
•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.
•Age_ 18-65 years
•Disease duration: 2-20 years
•EDSS 3,0-7,0

Exclusion Criteria

•Subtype of MS not fulfilling inclusion criteria
•Treatment with any immunosuppressive therapy, including natalizumab and fingolimod, within the 3 months prior to randomization
•Treatment with interferon-beta or glatiramer acetate within the 30 days prior to randomization
•Treatment with corticosteroids within the 30 days prior to randomization
•Relapse occurred during the 60 days prior to randomization
•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
•Severely limited life expectancy by another co-morbid illness
•Active or chronic severe infection.
•History of previous diagnosis of myelodysplasia or previous hematologic disease or current clinically relevant abnormalities of white blood cell counts
•Pregnancy or risk or pregnancy (this includes patients that are unwilling to practice active contraception during the duration of the study)

Outcomes

Primary Outcomes

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

Secondary Outcomes

To evaluate effects on MS disease activity measured by change in EDSS (expanded disability status scale).(48 weeks)
To evaluate effect on peripheral blood immune cell populations.(24 weeks)