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Master Thesis

Faisabilité et sécurité de l'injection de cellules souches mésenchymateuses autologues après un accident vasculaire cérébral ischémique dans le cadre d'une étude clinique pilote

Abstract : Stroke is not only the second cause of death worldwide but this is also the most common source of severe disability in adults. Indeed, more than half of the stroke survivors show disabilities, despite the currently available rehabilitation programs. Among all the therapeutic strategies in development, cell therapy could be an effective way to enhance recovery after stroke, by promoting the physiological neural protection and post-stroke plasticity occurring after stroke. Mesenchymal stem cells have recently received attention in several clinical fields, including stroke, for their potential therapeutic effects, mainly through immunomodulatory and paracrine mechanisms. This is especially the case in the ISIS clinical trial, a phase IIa, controlled and randomized trial assessing the feasibility and tolerance of the intravenous injection of autologous mesenchymal stem cells in patients with ischemic stroke. This present document aims at reporting and analyzing feasibility and safety data obtained during this trial. Very encouraging results were obtained regarding the tolerance and safety of the injection of mesenchymal stem cells, as no safety issue linked to this cell therapy was identified. Nevertheless, major feasibility issues linked to the production process of the stem cells were detected. After a careful analysis of those feasibility data, the use of autologous cells was identified as the main cause of the feasibility issues. This gave the opportunity to modify the cell therapy protocol by developing an allogenic cell therapy product for the next clinical phase at a European scale with more patients.
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Master Thesis
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https://dumas.ccsd.cnrs.fr/dumas-01341696
Contributor : Jean-Hugues Morneau <>
Submitted on : Monday, July 4, 2016 - 4:08:17 PM
Last modification on : Wednesday, July 15, 2020 - 8:56:03 AM
Long-term archiving on: : Wednesday, October 5, 2016 - 3:42:04 PM

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  • HAL Id : dumas-01341696, version 1

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Morgane Duparc. Faisabilité et sécurité de l'injection de cellules souches mésenchymateuses autologues après un accident vasculaire cérébral ischémique dans le cadre d'une étude clinique pilote. Sciences pharmaceutiques. 2015. ⟨dumas-01341696⟩

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