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Randomized placebo-controlled phase II trial of autologous mesenchymal stem cells in multiple sclerosis
- Source :
- Dipòsit Digital de la UB, Universidad de Barcelona, Recercat. Dipósit de la Recerca de Catalunya, instname, PLoS ONE, Vol 9, Iss 12, p e113936 (2014), Dadun. Depósito Académico Digital de la Universidad de Navarra, PLoS ONE
- Publication Year :
- 2014
- Publisher :
- Public Library of Science (PLoS), 2014.
-
Abstract
- OBJECTIVE: Uncontrolled studies of mesenchymal stem cells (MSCs) in multiple sclerosis suggested some beneficial effect. In this randomized, double-blind, placebo-controlled, crossover phase II study we investigated their safety and efficacy in relapsing-remitting multiple sclerosis patients. Efficacy was evaluated in terms of cumulative number of gadolinium-enhancing lesions (GEL) on magnetic resonance imaging (MRI) at 6 months and at the end of the study. METHODS: Patients unresponsive to conventional therapy, defined by at least 1 relapse and/or GEL on MRI scan in past 12 months, disease duration 2 to 10 years and Expanded Disability Status Scale (EDSS) 3.0-6.5 were randomized to receive IV 1-2×10(6) bone-marrow-derived-MSCs/Kg or placebo. After 6 months, the treatment was reversed and patients were followed-up for another 6 months. Secondary endpoints were clinical outcomes (relapses and disability by EDSS and MS Functional Composite), and several brain MRI and optical coherence tomography measures. Immunological tests were explored to assess the immunomodulatory effects. RESULTS: At baseline 9 patients were randomized to receive MSCs (n = 5) or placebo (n = 4). One patient on placebo withdrew after having 3 relapses in the first 5 months. We did not identify any serious adverse events. At 6 months, patients treated with MSCs had a trend to lower mean cumulative number of GEL (3.1, 95% CI = 1.1-8.8 vs 12.3, 95% CI = 4.4-34.5, p = 0.064), and at the end of study to reduced mean GEL (-2.8±5.9 vs 3±5.4, p = 0.075). No significant treatment differences were detected in the secondary endpoints. We observed a non-significant decrease of the frequency of Th1 (CD4+ IFN-γ+) cells in blood of MSCs treated patients. CONCLUSION: Bone-marrow-MSCs are safe and may reduce inflammatory MRI parameters supporting their immunomodulatory properties. ClinicalTrials.gov NCT01228266.
- Subjects :
- Male
Oncology
Pathology
T-Lymphocytes
medicine.medical_treatment
lcsh:Medicine
Phases of clinical research
Esclerosi múltiple
Stem cells
law.invention
Clinical trials
Randomized controlled trial
law
Medicine
lcsh:Science
B-Lymphocytes
Multidisciplinary
medicine.diagnostic_test
Stem-cell therapy
Middle Aged
Magnetic Resonance Imaging
Treatment Outcome
Neurology
Cèl·lules T
Magnetic resonance
Female
Cèl·lules mare
Autologous
Phase II clinical investigation
Research Article
Adult
medicine.medical_specialty
Multiple Sclerosis
Cèl·lules B
Immunology
T cells
Mesenchymal Stem Cell Transplantation
Placebo
Autoimmune Diseases
Multiple sclerosis
Young Adult
Multiple Sclerosis, Relapsing-Remitting
Double-Blind Method
Internal medicine
Humans
Medicine and health sciences
B cells
business.industry
lcsh:R
Mesenchymal stem cell
Ressonància magnètica
Biology and Life Sciences
Mesenchymal Stem Cells
Magnetic resonance imaging
Inflamatory MRI
medicine.disease
Demyelinating Disorders
Clinical trial
Clinical medicine
Mesenchymal stem cells
Clinical Immunology
lcsh:Q
business
Assaigs clínics
Subjects
Details
- Database :
- OpenAIRE
- Journal :
- Dipòsit Digital de la UB, Universidad de Barcelona, Recercat. Dipósit de la Recerca de Catalunya, instname, PLoS ONE, Vol 9, Iss 12, p e113936 (2014), Dadun. Depósito Académico Digital de la Universidad de Navarra, PLoS ONE
- Accession number :
- edsair.doi.dedup.....c4ba3eb96eaaeb5239a2865f91c1a1c7