Status:
COMPLETED
Mesenchymal Stem Cells for Progressive Multiple Sclerosis_Sweden
Lead Sponsor:
Karolinska Institutet
Conditions:
Autologous Mesenchymal Stem Cells
Multiple Sclerosis
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
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
- 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
- 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)
- eGFR \< 60 mL/min/1.73m2 or known renal failure or inability to undergo MRI examination.
- Inability to give written informed consent in accordance with research ethics board guidelines
Key Trial Info
Start Date :
December 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2016
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT03778333
Start Date
December 1 2012
End Date
December 31 2016
Last Update
June 1 2023
Active Locations (2)
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1
Karolinska Institute, Karolinska University Hospital Solna
Stockholm, Sweden, 171 76
2
Karolinska Institute, Karolinska University Hospital
Stockholm, Sweden, 17176