Multiple Sclerosis
Conditions
Keywords
Multiple Sclerosis
Brief summary
The study is a randomized Phase II study, masked and crossed-over with placebo to evaluate the safety and tolerability of autologous mesenchymal stem cell transplantation in patients with active multiple sclerosis
Interventions
BIOLOGICALautologous mesenchymal stem cells
A randomized double-blind, crossover study comparing treatment with autologous MSC vs. suspension media on patients with active MS
Sponsors
Instituto de Salud Carlos III
Albert Saiz
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
1. Inflammatory forms of MS 1. Relapsing-remitting MS (RRMS) patients 2. Secondary progressive MS (SPMS) patients with continued relapses 3. Primary progressive MS (PPMS) patients with enhancing MRI lesions and positive CSF (oligoclonal banding) 2. Age 18-50 years 3. Disease duration \>= 2 and \>= 10 years 4. EDSS 3.0 - 6.5 5. Progression, continued relapses or worsening MRI after at least a year of attempted therapy evidenced by: 1. Increase of \>= 1 EDSS point (if baseline EDSS \<= 5.0) or 0.5 EDSS points (if baseline EDSS \>= 5.5), or quantifiable, objective evidence of equivalent progression 2. \>= 1 moderate-severe relapses in past 18 months 3. \>= 1 Gadolinium enhancing lesions (double or triple dose Gadolinium) 4. \>= 1 new T2 lesion 5. For PPMS only, \>= 1 Gadolinium enhancing lesions 6. Has given informed consent to participate in the study.
Exclusion criteria
1. SPMS without ongoing relapses 2. PPMS without positive CSF or Gadolinium enhancing lesions 3. \<= 3 months since treatment with any immunosuppressive therapy 4. \<=1 month since last treatment with interferon-B or glatiramer acetate 5. Corticosteroid treatment \<= 30 days 6. Relapse \<= 60 days 7. History of cancer or clinical or laboratory results indicative of severe systemic diseases, including infection for HIV, Hepatitis B or C 8. Any metallic or electronic device that precludes from undergoing MRI 9. Pregnancy or lactation 10. Current treatment with an investigational therapy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To evaluate the safety as number of severe events along 1 year, and efficacy in terms of cumulative number of gadolinium-enhancing lesions in MRI at 6 months and at the end of the study | 12 months | The coprimary endpoints were safety and efficacy in terms of cumulative number of gadolinium-enhancing lesions in MRI |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To evaluate effects on MS disease activity measured by: clinical variables, MRI, OCT, immunological analysis and quality of life scales | 12 months | clinical outcomes (number of relapses and change in the EDSS); MRI-based measures and OCT. Immunological evaluation as exploratory analysis |
Countries
Spain
Outcome results
None listed