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Journal of Translational Medicine
Published in: Journal of Translational Medicine 1/2014

Open Access 01-12-2014 | Protocol

Autologous mesenchymal stem cell therapy for progressive supranuclear palsy: translation into a phase I controlled, randomized clinical study

Authors: Rosaria Giordano, Margherita Canesi, Maurizio Isalberti, Ioannis Ugo Isaias, Tiziana Montemurro, Mariele Viganò, Elisa Montelatici, Valentina Boldrin, Riccardo Benti, Agostino Cortelezzi, Nicola Fracchiolla, Lorenza Lazzari, Gianni Pezzoli

Published in: Journal of Translational Medicine | Issue 1/2014

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Abstract

Background

Progressive Supranuclear Palsy (PSP) is a sporadic and progressive neurodegenerative disease which belongs to the family of tauopathies and involves both cortical and subcortical structures. No effective therapy is to date available.

Methods/design

Autologous bone marrow (BM) mesenchymal stem cells (MSC) from patients affected by different type of parkinsonisms have shown their ability to improve the dopaminergic function in preclinical and clinical models. It is also possible to isolate and expand MSC from the BM of PSP patients with the same proliferation rate and immuphenotypic profile as MSC from healthy donors. BM MSC can be efficiently delivered to the affected brain regions of PSP patients where they can exert their beneficial effects through different mechanisms including the secretion of neurotrophic factors.
Here we propose a randomized, placebo-controlled, double-blind phase I clinical trial in patients affected by PSP with MSC delivered via intra-arterial injection.

Discussion

To our knowledge, this is the first clinical trial to be applied in a no-option parkinsonism that aims to test the safety and to exploit the properties of autologous mesenchymal stem cells in reducing disease progression. The study has been designed to test the safety of this “first-in-man” approach and to preliminarily explore its efficacy by excluding the placebo effect.

Trial registration

NCT01824121
Appendix
Available only for authorised users
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Metadata
Title
Autologous mesenchymal stem cell therapy for progressive supranuclear palsy: translation into a phase I controlled, randomized clinical study
Authors
Rosaria Giordano
Margherita Canesi
Maurizio Isalberti
Ioannis Ugo Isaias
Tiziana Montemurro
Mariele Viganò
Elisa Montelatici
Valentina Boldrin
Riccardo Benti
Agostino Cortelezzi
Nicola Fracchiolla
Lorenza Lazzari
Gianni Pezzoli
Publication date
01-12-2014
Publisher
BioMed Central
Published in
Journal of Translational Medicine / Issue 1/2014
Electronic ISSN: 1479-5876
DOI
https://doi.org/10.1186/1479-5876-12-14

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