Evidence map›Paper›PMID 31072380›Full record

ArticleTrials2019

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.

Antonio Uccelli, Alice Laroni, Lou Brundin, Michel Clanet, Oscar Fernandez, Seyed Massood Nabavi, Paolo A Muraro, Roberto S Oliveri, Ernst W Radue, Johann Sellner and 6 more

7 registry-linked trialsOpen access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 7 registered trials, which are not on this map. Cited by 50 papers.

0numbers the graph read from it
0cells of the map it votes in
50citing papers in PubMed
8.6field-weighted citation impact, top 2% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01606215 phase1 / phase2completednot on this map

Stem Cells in Rapidly Evolving Active Multiple Sclerosis

TypeinterventionalSponsorImperial College LondonRan2013 to 2019Enrolled21ConditionsMultiple SclerosisArmsMesenchymal stem cells, Placebo
NCT01730547 phase1 / phase2completednot on this map

Phase 1/2 Clinical Trial With Autologous Mesenchymal Stem Cells for the Therapy of Multiple Sclerosis

TypeinterventionalSponsorKarolinska InstitutetRan2013 to 2021Enrolled2ConditionsMultiple SclerosisArmsAutologous mesenchymal stem cells
NCT01745783 phase1 / phase2completednot on this map

Clinical Trial Phase I / II Multicenter, Randomized, Crossover, Double-blind Evaluation of the Safety and Feasibility of Systemic Therapy With Mesenchymal Cells Derived From Autologous Bone Marrow in Patients With Multiple Sclerosis

TypeinterventionalSponsorAndalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y SaludRan2013 to 2020Enrolled26ConditionsMultiple SclerosisArmsBone marrow mesenchymal stem cells autologous, Placebo comparator
NCT01854957 phase1 / phase2unknown statusnot on this map

MEsenchymal StEm Cells for Multiple Sclerosis (MESEMS) Phase I-II Clinical Trial With Autologous Mesenchymal Stem Cells (MSCs) for the Therapy of Multiple Sclerosis

TypeinterventionalSponsorAntonio UccelliRan2012 to 2014Enrolled20ConditionsMultiple SclerosisArmsAutologous Mesenchymal Stem Cells
NCT02035514 phase1 / phase2completednot on this map

Phase I-II Clinical Trial With Autologous Bone Marrow Derived Mesenchymal Stem Cells for the Therapy of Multiple Sclerosis

TypeinterventionalSponsorGermans Trias i Pujol HospitalRan2013 to 2016Enrolled9ConditionsRelapsing Remitting Multiple Sclerosis (RRMS)ArmsBone marrow autologous mesenchymal stem cells transplantation
NCT02239393 phase2completednot on this map

MEsenchymal Stem Cell Therapy for CAnadian MS Patients

TypeinterventionalSponsorOttawa Hospital Research InstituteRan2015 to 2019Enrolled31ConditionsMultiple SclerosisArmsMesenchymal Stem Cells
NCT02403947 phase1 / phase2terminatednot on this map

Treatment of Multiple Sclerosis With Mesenchymal Stem Cells: Phase I/II Study

TypeinterventionalSponsorUniversity Hospital, ToulouseRan2015 to 2017Enrolled1ConditionsMultiple SclerosisArmsMesenchymal stem cells, Suspension media
3 · Its place in the literature

Who cites it

50 citing papers in PubMed, 92 citations in OpenAlex.

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  7. Enteric nervous system as a therapeutic target in gastrointestinal disorders.World journal of gastrointestinal pharmacology and therapeutics · 2025
    Article
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  9. Article
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  11. Progressive multiple sclerosis: Evaluating current therapies and exploring future treatment strategies.Neurotherapeutics : the journal of the American Society for Experimental NeuroTherapeutics · 2025
    Review
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  19. Internalization of transferrin-taggedExperimental biology and medicine (Maywood, N.J.) · 2024
    Article
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

16 authors at 11 institutions in 10 countries.

Antonio UccelliDepartment of Neuroscience, Rehabilitation, Ophthalmology, Genetics, Maternal and Child Health and Center of Excellence for Biomedical Research (CEBR), University of Genova, Largo Daneo 3, 16132, Genoa, Italy. auccelli@neurologia.unige.it.ORCID http://orcid.org/0000-0002-2008-6038
Alice LaroniDepartment of Neuroscience, Rehabilitation, Ophthalmology, Genetics, Maternal and Child Health and Center of Excellence for Biomedical Research (CEBR), University of Genova, Largo Daneo 3, 16132, Genoa, Italy.
Lou BrundinKarolinska Institutet, R3:04 Karolinska University Hospital 171 76, Stockholm, Sweden.
Michel ClanetCHU Toulouse, Université Paul Sabatier, INSERM UMR, 1043, Toulouse, France.
Oscar FernandezInstituto de Investigación Biomédica de Málaga (IBIMA), Regional University Hospital of Malaga, Malaga, Spain.
Seyed Massood NabaviDepartment of Brain and Cognitive Sciences, Royan Institute for Stem Cell Biology and Technology, Royan, Iran.
Paolo A MuraroDepartment of Brain Sciences, Faculty of Medicine, Imperial College London, London, UK.
Roberto S OliveriCell Therapy Unit, Department of Clinical Immunology, Copenhagen University Hospital Rigshospitalet, Copenhagen, Denmark.
Ernst W RadueMedical Image Analysis Centre Basel (MIAC AG), Basel, Switzerland.
Johann SellnerDepartment of Neurology, Christian Doppler Medical Center, Paracelsus Medical University, Salzburg, Austria.
Per Soelberg SorensenDanish MS Center Department of Neurology, University of Copenhagen and Rigshospitalet, Copenhagen, Denmark.
Maria Pia SormaniDepartment of Health Sciences, University of Genoa, Genoa, Italy.
Jens Thomas WuerfelMedical Image Analysis Centre Basel (MIAC AG), Basel, Switzerland.
Mario A BattagliaItalian Multiple Sclerosis Foundation, Genoa, Italy.
Mark S FreedmanDepartment of Medicine (Neurology), University of Ottawa and the Ottawa Hospital Research Institute, Ottawa, Ontario, Canada.
MESEMS study group
Copenhagen University Hospital · DKKarolinska University Hospital · SERoyan Institute · IRUniversity of Copenhagen · DKUniversity of Genoa · ITOspedale Policlinico San Martino · ITParacelsus Medical University · ATUniversité Toulouse III - Paul Sabatier · FRUniversity of Basel · CHUniversity of Ottawa · CAUniversity of Siena · IT

Funding

Fondazione Italiana Sclerosi Multipla 2012/S/4Multiple Sclerosis Society 938/10
6 · The paper itself

Abstract

backgroundMultiple 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/

designThis 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 registrationAndalusia: 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.

Indexed as

Mesenchymal Stem Cell TransplantationAdolescentAdultClinical Trials, Phase I as TopicClinical Trials, Phase II as TopicCross-Over StudiesDisability EvaluationDouble-Blind MethodEuropeFemaleHumansMagnetic Resonance ImagingMaleMiddle AgedMulticenter Studies as TopicMultiple SclerosisClinical trialMesenchymal stem cellsMesenchymal stromal cellsMultiple sclerosis

Identifiers

PMID31072380
PMCPMC6507027
OpenAlexW2947706849

What OpenQuestion holds

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LicenceCC BY
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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.