Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
9 participants
INTERVENTIONAL
2010-12-31
2013-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
DOUBLE
Study Groups
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autologous mesenchymal stem cell
A single infusion of up to 2 million cells per Kg of autologous mesenchymal stem cells vs suspension media. The treatment will be reversed at 6 months
autologous mesenchymal stem cells
A randomized double-blind, crossover study comparing treatment with autologous MSC vs. suspension media on patients with active MS
Interventions
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autologous mesenchymal stem cells
A randomized double-blind, crossover study comparing treatment with autologous MSC vs. suspension media on patients with active MS
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
50 Years
ALL
No
Sponsors
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Instituto de Salud Carlos III
OTHER_GOV
Albert Saiz
OTHER
Responsible Party
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Albert Saiz
MD
Principal Investigators
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Albert Saiz, MD
Role: PRINCIPAL_INVESTIGATOR
Hospital Clinic of Barcelona
Locations
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Neurology Service, Hospital Clinic de barcelona
Barcelona, Barcelona, Spain
Countries
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References
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Llufriu S, Sepulveda M, Blanco Y, Marin P, Moreno B, Berenguer J, Gabilondo I, Martinez-Heras E, Sola-Valls N, Arnaiz JA, Andreu EJ, Fernandez B, Bullich S, Sanchez-Dalmau B, Graus F, Villoslada P, Saiz A. Randomized placebo-controlled phase II trial of autologous mesenchymal stem cells in multiple sclerosis. PLoS One. 2014 Dec 1;9(12):e113936. doi: 10.1371/journal.pone.0113936. eCollection 2014.
Other Identifiers
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CMM-EM
Identifier Type: -
Identifier Source: org_study_id
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