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MESEMS: a randomized, double blind placebo-controlled cross-over study to evaluate safety and efficacy of intravenous administration of autologous mesenchymal stem cells in patients with multiple sclerosis
Author(s): ,
A. Uccelli
Affiliations:
University of Genova, Genova, Italy
,
L. Brundin
Affiliations:
Karolinska Insitutet, Stockholm, Sweden
,
M. Clanet
Affiliations:
University of Toulouse, Toulouse, France
,
O. Fernandez
Affiliations:
Hospital Regional Universitario Carlos Haya, Malaga, Spain
,
A. Laroni
Affiliations:
University of Genova, Genova, Italy
,
P. Muraro
Affiliations:
Imperial College London, London, United Kingdom
,
R. Oliveri
Affiliations:
University of Copenhagen, Copenhagen, Denmark
,
E.-W. Radue
Affiliations:
Medical Image Analysis Center, Universitätsspital Basel, Basel, Switzerland
,
P. Soelberg Sorensen
Affiliations:
University of Copenhagen, Copenhagen, Denmark
,
M.P. Sormani
Affiliations:
University of Genova, Genova, Italy
M.S. Freedman
Affiliations:
Ottawa Hospital, Ottawa, ON, Canada
ECTRIMS Online Library. Uccelli A. Oct 9, 2015; 116019; 1561
Prof. Antonio Uccelli
Prof. Antonio Uccelli
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Abstract: P1087

Type: Poster

Abstract Category: Neuroprotection

Background: Mesenchymal stem cells (MSC) have been demonstrated to ameliorate experimental autoimmune encephalomyelitis through the induction of immune tolerance and promotion of tissue repair. Based on this rationale the International Mesenchymal Stem Cells Transplantation Study Group generated a scientific consensus through a shared approach devising a protocol for a potential phase II trial.

Aims: To describe the protocol for a phase II trial assessing safety and efficacy of MEsenchymal StEm cells for the treatment of Multiple Sclerosis (MESEMS).

Methods: The MESEMS network is a group of independent clinical trials, following the same protocol and sharing key centralized procedures: analysis of MRI data (Basel, Switzerland); central randomization and collection of safety and clinical data (Genoa, Italy). The design will permit pooled analysis of data for the evaluation of primary and secondary objectives. Funding was obtained nationally through foundations and MS Societies, while the Italian MS Foundation, MSIF and ECTRIMS have financially supported coordination and centralized activities.

Results: MESEMS is being investigated in 8 countries, with an anticipated enrollment of 160 MS patients. The MESEMS protocol is a double-blind, randomized, sham-controlled cross-over trial. The main inclusion criteria are: relapsing-remitting, secondary progressive or primary progressive MS displaying disease activity by clinical and MRI parameters, age 18-50, EDSS 3.0-6.5 and disease duration 2-10 years. The primary endpoints are safety and efficacy of autologous MSC in MS patients by measuring the total number of gadolinium enhancing lesions on MRI at week 4, 12 and 24 in the MSC vs. sham treatment groups. Secondary outcomes aim to gather preliminary information of the efficacy on other MRI metrics, clinical, immunological, neuropsychological and neuro-ophthalmological parameters. Two trial treatments, one with 1-2 millions of autologous bone marrow-derived MSC/Kg body weight and one with sham (media), are administered at week 0 and week 24 according to randomization. The total follow up is 48 weeks.

Conclusion
: A novel network approach has permitted us to overcome financial and logistic issues and to start an International academic trial with stem cells for MS. Results of the MESEMS trial will permit us to evaluate the safety and efficacy of MSC in MS and provide the rationale for designing a phase III program that will center on proving repair.

Disclosure: Fundings for the study

Fondazione Italiana Sclerosi Multipla

ECTRIMS

MSIF

UK Multiple Sclerosis Society

UK Stem Cell Foundation

UK Clinical Trials Network

The Danish Multiple Sclerosis Society

ARSEP Association pour la Recherche sur la Sclérose En Plaques

Vetenskapsrådet, Sweden

Theme Center for Regenerative Medicine, Karolinska Institute, Sweden

Neurology Clinic, Karolinska University Hospital, Stockholm

Institute of Health Carlos III (Badalona)

FIMABIS (Andalusian Public Foundation for Health and Biomedicine Research in Malaga)

Andalusian Initiative for Advanced Therapies - Health and Progress Foundation

MS society of Canada

Antonio Uccelli: nothing to disclose about the topic of this abstract

Lou Brundin: nothing to disclose about the topic of this abstract

Michel Clanet: nothing to disclose about the topic of this abstract

Oscar Fernandez: nothing to disclose about the topic of this abstract

Alice Laroni: nothing to disclose about the topic of this abstract

Paolo Muraro: nothing to disclose about the topic of this abstract

Roberto Oliveri: nothing to disclose about the topic of this abstract

Ernst-Wilhelm Radue: nothing to disclose about the topic of this abstract

Per Sorensen-Solberg: nothing to disclose about the topic of this abstract

Maria Pia Sormani: nothing to disclose about the topic of this abstract

Mark Freedman: nothing to disclose about the topic of this abstract

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