Please use this identifier to cite or link to this item: http://hdl.handle.net/10668/3192
Title: MEsenchymal StEm cells for Multiple Sclerosis (MESEMS): a randomized, double blind, cross-over phase I/II clinical trial with autologous mesenchymal stem cells for the therapy of multiple sclerosis
Authors: Uccelli, Antonio
Laroni, Alice
Brundin, Lou
Clanet, Michel
Fernandez, Oscar
Nabavi, Seyed Massood
Muraro, Paolo A.
Oliveri, Roberto S.
Radue, Ernst W.
Sellner, Johann
Soelberg Sorensen, Per
Sormani, Maria Pia
Wuerfel, Jens Thomas
Battaglia, Mario. A.
Freedman, Mark S.
metadata.dc.contributor.authoraffiliation: [Uccelli,A; Laroni,A] Department of Neuroscience, Rehabilitation, Ophthalmology, Genetics, Maternal and Child Health and Center of Excellence for Biomedical Research (CEBR), University of Genova, Genoa, Italy. [Uccelli,A; Laroni,A] IRCCS Ospedale Policlinico San Martino, Genoa, Italy. [Brundin,L] Karolinska Institutet, Karolinska University Hospital, Stockholm, Sweden [Clanet,M] CHU Toulouse, Université Paul Sabatier, Toulouse, France. [Fernandez,O] Instituto de Investigación Biomédica de Málaga (IBIMA), Regional University Hospital of Malaga, Malaga, Spain. [Nabavi,SM] Department of Brain and Cognitive Sciences, Royan Institute for Stem Cell Biology and Technology, Royan, Iran. [Nabavi,SM] ACCR, Iran and Regenerative Biomedicine Center, MS, Neurology Clinic and Research Unit, Tehran, Iran. [Muraro,PA] Department of Brain Sciences, Faculty of Medicine, Imperial College London, London, UK. [Oliveri,RS] Cell Therapy Unit, Department of Clinical Immunology, Copenhagen University Hospital Rigshospitalet, Copenhagen, Denmark. [Radue,EW; Wuerfel,JT] Medical Image Analysis Centre Basel (MIAC AG), Basel, Switzerland. [Sellner,J] Department of Neurology, Christian Doppler Medical Center, Paracelsus Medical University, Salzburg, Austria. [Soelberg Sorensen,P] Danish MS Center Department of Neurology, University of Copenhagen and Rigshospitalet, Copenhagen, Denmark. [Sormani,MP] Department of Health Sciences, University of Genoa, Genoa, Italy. [Wuerfel,JT] Department of Biomedical Engineering, University Basel, Basel, Switzerland. [Battaglia,MA] Italian Multiple Sclerosis Foundation, Genoa, Italy. [Battaglia,MA] Department of Life Sciences, University of Siena, Siena, Italy. [Freedman,MS] Department of Medicine (Neurology), University of Ottawa and the Ottawa Hospital Research Institute, Ottawa, Ontario, Canada.
metadata.dc.contributor.group: MESEMS study group
Keywords: Multiple sclerosis;Mesenchymal stem cells;Mesenchymal stromal cells;Clinical trial;Esclerosis múltiple;Células madre mesenquimatosas;Ensayo clínico
metadata.dc.subject.mesh: Medical Subject Headings::Persons::Persons::Age Groups::Adolescent
Medical Subject Headings::Persons::Persons::Age Groups::Adult
Medical Subject Headings::Analytical, Diagnostic and Therapeutic Techniques and Equipment::Investigative Techniques::Epidemiologic Methods::Epidemiologic Study Characteristics as Topic::Clinical Trials as Topic::Clinical Trials, Phase I as Topic
Medical Subject Headings::Analytical, Diagnostic and Therapeutic Techniques and Equipment::Investigative Techniques::Epidemiologic Methods::Epidemiologic Study Characteristics as Topic::Clinical Trials as Topic::Clinical Trials, Phase II as Topic
Medical Subject Headings::Analytical, Diagnostic and Therapeutic Techniques and Equipment::Investigative Techniques::Epidemiologic Methods::Epidemiologic Research Design::Cross-Over Studies
Medical Subject Headings::Analytical, Diagnostic and Therapeutic Techniques and Equipment::Diagnosis::Diagnostic Techniques and Procedures::Disability Evaluation
Medical Subject Headings::Analytical, Diagnostic and Therapeutic Techniques and Equipment::Investigative Techniques::Epidemiologic Methods::Epidemiologic Research Design::Double-Blind Method
Medical Subject Headings::Geographical Locations::Geographic Locations::Europe::Europe, Eastern
Medical Subject Headings::Check Tags::Female
Medical Subject Headings::Organisms::Eukaryota::Animals::Chordata::Vertebrates::Mammals::Primates::Haplorhini::Catarrhini::Hominidae::Humans
Medical Subject Headings::Analytical, Diagnostic and Therapeutic Techniques and Equipment::Diagnosis::Diagnostic Techniques and Procedures::Diagnostic Imaging::Magnetic Resonance Imaging
Medical Subject Headings::Check Tags::Male
Medical Subject Headings::Analytical, Diagnostic and Therapeutic Techniques and Equipment::Surgical Procedures, Operative::Transplantation::Cell Transplantation::Stem Cell Transplantation::Mesenchymal Stem Cell Transplantation
Medical Subject Headings::Persons::Persons::Age Groups::Adult::Middle Aged
Medical Subject Headings::Analytical, Diagnostic and Therapeutic Techniques and Equipment::Investigative Techniques::Epidemiologic Methods::Epidemiologic Study Characteristics as Topic::Clinical Trials as Topic::Multicenter Studies as Topic
Medical Subject Headings::Diseases::Nervous System Diseases::Autoimmune Diseases of the Nervous System::Demyelinating Autoimmune Diseases, CNS::Multiple Sclerosis
Medical Subject Headings::Analytical, Diagnostic and Therapeutic Techniques and Equipment::Investigative Techniques::Epidemiologic Methods::Epidemiologic Study Characteristics as Topic::Clinical Trials as Topic::Controlled Clinical Trials as Topic::Randomized Controlled Trials as Topic
Medical Subject Headings::Phenomena and Processes::Biological Phenomena::Recovery of Function
Medical Subject Headings::Phenomena and Processes::Physical Phenomena::Time::Time Factors
Medical Subject Headings::Analytical, Diagnostic and Therapeutic Techniques and Equipment::Surgical Procedures, Operative::Transplantation::Transplantation, Autologous
Medical Subject Headings::Analytical, Diagnostic and Therapeutic Techniques and Equipment::Diagnosis::Prognosis::Treatment Outcome
Issue Date: 9-May-2019
Publisher: BioMed Central Ltd.
Citation: Uccelli A, Laroni A, Brundin L, Clanet M, Fernandez O, Nabavi SM, et al. MEsenchymal StEm cells for Multiple Sclerosis (MESEMS): a randomized, double blind, cross-over phase I/II clinical trial with autologous mesenchymal stem cells for the therapy of multiple sclerosis. Trials. 2019 May 9;20(1):263.
Abstract: Background: Multiple sclerosis (MS) is an inflammatory disease of the central nervous system with a degenerative component, leading to irreversible disability. Mesenchymal stem cells (MSC) have been shown to prevent inflammation and neurodegeneration in animal models of MS, but no large phase II clinical trials have yet assessed the exploratory efficacy of MSC for MS. Methods/design: This is an academic, investigator-initiated, randomized, double-blind, placebo-compared phase I/II clinical trial with autologous, bone-marrow derived MSC in MS. Enrolled subjects will receive autologous MSC at either baseline or at week 24, through a cross-over design. Primary co-objectives are to test safety and efficacy of MSC treatment compared to placebo at 6 months. Secondary objectives will evaluate the efficacy of MSC at clinical and MRI levels. In order to overcome funding constraints, the MEsenchymal StEm cells for Multiple Sclerosis (MESEMS) study has been designed to merge partially independent clinical trials, following harmonized protocols and sharing some key centralized procedures, including data collection and analyses. Discussion: Results will provide patients and the scientific community with data on the safety and efficacy of MSC for MS. The innovative approach utilized to obtain funds to support the MESEMS trial could represent a new model to circumvent limitation of funds encountered by academic trials.Trial registration: Andalusia: NCT01745783 , registered on Dec 10, 2012. Badalona: NCT02035514 EudraCT, 2010-024081-21. Registered on 2012. Canada: ClinicalTrials.gov, NCT02239393 . Registered on September 12, 2014. Copenhagen: EudraCT, 2012-000518-13 . Registered on June 21, 2012. Italy: EudraCT, 2011-001295-19, and ClinicalTrials.gov, NCT01854957 . Retrospectively registered on May 16, 2013. London: Eudra CT 2012-002357-35, and ClinicalTrials.gov, NCT01606215 . Registered on May 25, 2012. Salzburg: EudraCT, 2015-000137-78 . Registered on September 15, 2015. Stockholm: ClinicalTrials.gov, NCT01730547 . Registered on November 21, 2012. Toulouse: ClinicalTrials.gov, NCT02403947 . Registered on March 31, 2015.
URI: http://hdl.handle.net/10668/3192
metadata.dc.relation.publisherversion: https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-019-3346-z
metadata.dc.identifier.doi: 10.1186/s13063-019-3346-z
ISSN: 1745-6215 (Online)
Appears in Collections:01- Artículos - IBIMA. Instituto de Investigación Biomédica de Málaga

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