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Mesenchymal stem cell secretome and extracellular vesicles for neurodegenerative diseases: Risk-benefit profile and next steps for the market access

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Bioactive Materials 2023年第11期29卷 16-35页

作者： Lorella Giovannelli Elia Bari Claudio Jommi Fulvio Tartara Daniele Armocida Diego Garbossa Fabio Cofano Maria Luisa Torre Lorena Segale Department of Pharmaceutical Sciences University of Piemonte Orientale28100NovaraItaly IRCCS Mondino Foundation 27100PaviaItaly A.U.O Policlinico Umberto INeurosurgery DivisionHuman Neurosciences DepartmentSapienza University00135RomaItaly Department of Neuroscience Rita Levi Montalcini Neurosurgery UnitUniversity of Turin10126TurinItaly PharmaExceed S.r.l 27100PaviaItaly

Neurodegenerative diseases represent a growing burden on healthcare systems worldwide. Mesenchymal stem cells (MSCs) have shown promise as a potential therapy due to their neuroregenerative, neuroprotective, and immunomodulatory properties, which are, however, linked to the bioactive substances they release, collectively known as secretome. This paper provides an overview of the most recent research on the safety and efficacy of MSC-derived secretome and extracellular vesicles (EVs) in clinical (if available) and preclinical models of Alzheimer’s disease, Parkinson’s disease, amyotrophic lateral sclerosis, multiple sclerosis, Huntington’s disease, acute ischemic stroke, and spinal cord injury. The article explores the biologically active substances within MSC-secretome/EVs, the mechanisms responsible for the observed therapeutic effects, and the strategies that may be used to optimize MSC-secretome/EVs production based on specific therapeutic needs. The review concludes with a critical discussion of current clinical trials and a perspective on potential future directions in translating MSC-secretome and EVs into the clinic, specifically regarding how to address the challenges associated with their pharmaceutical manufacturing, including scalability, batch-to-batch consistency, adherence to Good Manufacturing Practices (GMP) guidelines, formulation, and storage, along with quality controls, access to the market and relative costs, value for money and impact on total expenditure.

关键词： Exosomes microvesicles secretome Mesenchymal stem cells secretome formulation Brain regeneration

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