Proposals submitted to the FDA for MSC-based products are undergoing a rapid expansion that is characterized by increased variability in donor and tissue sources, manufacturing processes, proposed functional mechanisms, and characterization methods. Here we discuss the diversity in MSC-based clinical trial product proposals and highlight potential challenges for clinical translation.
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Nuclear respiratory factor-1 (NRF1) induction as a powerful strategy to deter mitochondrial dysfunction and senescence in mesenchymal stem cells.
Aging Cell
December 2024
Department of Nanomedicine, Houston Methodist Research Institute, Houston, Texas, USA.
Mesenchymal stem cells (MSCs) are promising candidates for regenerative therapies due to their self-renewal and differentiation capabilities. Pathological microenvironments expose MSCs to senescence-inducing factors such as reactive oxygen species (ROS), resulting in MSC functional decline and loss of stemness. Oxidative stress leads to mitochondrial dysfunction, a hallmark of senescence, and is prevalent in aging tissues characterized by elevated ROS levels.
View Article and Find Full Text PDFGood Manufacturing Practice-grade fibronectin for hollow-fiber bioreactor cell manufacture: a mesenchymal stromal cell case study.
Cytotherapy
December 2024
Terumo Blood and Cell Technologies, Inc., Lakewood, Colorado, USA.
Background Aims: The need for large-scale production of mesenchymal stromal cell (MSC)-based cellular therapeutics continues to grow around the globe. Manual cell expansion processes can be highly variable between operators, require significant hands-on time from skilled staff and, because of the large number of open manipulation steps required to produce cells in dose-relevant quantities, be prone to greater risk of contamination relative to automated processes. All of these can increase overall production costs and risks to the patient.
View Article and Find Full Text PDFEnhanced Chondrogenic Differentiation of Electrically Primed Human Mesenchymal Stem Cells for the Regeneration of Osteochondral Defects.
Biomater Res
December 2024
School of Materials Science and Engineering, Gwangju Institute of Science and Technology, Gwangju 61005, Republic of Korea.
Mesenchymal stem cells (MSCs) offer a promising avenue for cartilage regeneration; however, their therapeutic efficacy requires substantial improvement. Cell priming using electrical stimulation (ES) is a promising approach to augmenting the therapeutic potential of MSCs and has shown potential for various regenerative applications. This study aimed to promote the ES-mediated chondrogenic differentiation of human MSCs and facilitate the repair of injured articular cartilage.
View Article and Find Full Text PDFDevelopment of a novel gene expression panel for the characterization of MSCs for increased biological safety.
J Appl Genet
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Research and Development Department, Polski Bank Komórek Macierzystych S.A. (FamiCord Group), Warsaw, Poland.
Mesenchymal stromal cells (MSCs) have a wide range of therapeutic applications due to their multipotency, immunomodulatory, and anti-inflammatory properties. Their ability to migrate and recolonize damaged tissues is also remarkable. However, the controversial occurrence of spontaneous tumorigenesis or malignant transformation of MSCs raises concerns about proposed cell-based therapies for patients that researchers must address.
View Article and Find Full Text PDFMolecular Mechanisms Responsible for Mesenchymal Stem Cell-Dependent Attenuation of Tear Hyperosmolarity and Immune Cell-Driven Inflammation in the Eyes of Patients with Dry Eye Disease.
Diseases
October 2024
Departments of Genetics, Microbiology and Immunology, Center for Research on Harmful Effects of Biological and Chemical Hazards, Faculty of Medical Sciences, University of Kragujevac, 69 Svetozara Markovica Street, 34000 Kragujevac, Serbia.
Background: Dry eye disease (DED) is a chronic condition characterized by a decrease in tear production or an increase in tear evaporation, leading to inflammation and damage of the ocular surface. Dysfunction of ion channels, tear hyperosmolarity and immune cell-driven inflammation create a vicious circle responsible for the pathological changes in the eyes of DED patients. Mesenchymal stem cells (MSCs) are adult, rapidly proliferating stem cells that produce a large number of immunoregulatory, angiomodulatory, and growth factors that efficiently reduce tear hyperosmolarity-induced pathological changes, inhibit harmful immune response, and provide trophic support to the injured corneal and conjuctival epithelial cells, goblet cells and acinar cells in lacrimal glands of DED patients.
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