Status:
TERMINATED
Mesenchymal Stem Cell Transplantation in MS
Lead Sponsor:
Albert Saiz
Collaborating Sponsors:
Instituto de Salud Carlos III
Conditions:
Multiple Sclerosis
Eligibility:
All Genders
18-50 years
Phase:
PHASE2
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 multi...
Eligibility Criteria
Inclusion
- Inflammatory forms of MS
- Relapsing-remitting MS (RRMS) patients
- Secondary progressive MS (SPMS) patients with continued relapses
- Primary progressive MS (PPMS) patients with enhancing MRI lesions and positive CSF (oligoclonal banding)
- Age 18-50 years
- Disease duration \>= 2 and \>= 10 years
- EDSS 3.0 - 6.5
- Progression, continued relapses or worsening MRI after at least a year of attempted therapy evidenced by:
- 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
- \>= 1 moderate-severe relapses in past 18 months
- \>= 1 Gadolinium enhancing lesions (double or triple dose Gadolinium)
- \>= 1 new T2 lesion
- For PPMS only, \>= 1 Gadolinium enhancing lesions
- Has given informed consent to participate in the study.
Exclusion
- SPMS without ongoing relapses
- PPMS without positive CSF or Gadolinium enhancing lesions
- \<= 3 months since treatment with any immunosuppressive therapy
- \<=1 month since last treatment with interferon-B or glatiramer acetate
- Corticosteroid treatment \<= 30 days
- Relapse \<= 60 days
- History of cancer or clinical or laboratory results indicative of severe systemic diseases, including infection for HIV, Hepatitis B or C
- Any metallic or electronic device that precludes from undergoing MRI
- Pregnancy or lactation
- Current treatment with an investigational therapy
Key Trial Info
Start Date :
December 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2013
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT01228266
Start Date
December 1 2010
End Date
December 1 2013
Last Update
February 13 2014
Active Locations (1)
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1
Neurology Service, Hospital Clinic de barcelona
Barcelona, Barcelona, Spain, 08036