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So concluded experts from the US Food and Drug Administration (FDA) in the New England Journal of Medicine (http://iacld.ir/DL/elm/95/clarifying%20stem%20c...).
It turns out that a therapy based on transplanting living cells from donors into the patient's body is anything but simple.
The first key issue with stem cell therapy is the question mark over safety. Introducing foreign living cells into a system as complex as the human body is challenging.
From kidney failure to patients left blinded by stem cell therapy, a growing list of cautionary examples catalogue how things can go wrong when unproven stem cell therapies are used in the clinic1.
Dr Ian Dixon of Exopharm, Australia (https://exopharm.com/the-next-big-thing-exosomes-versus-stem-cells/), "We now know that the old working hypothesis for how stem cells exert their regenerative effects was wrong." Enter, Exsosomes.
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As researchers from Oxford2 to Scripps3 have now concluded, it's the exosomes stem cells release, rather than the cells themselves, that impart the regenerative benefit.
"Exosome therapy would avoid all the problems of a therapy based on live stem cells and yet harness a natural regenerative capability from stem cells", says Dixon.
Tellingly, several biotech stocks established back in the early 2000's as stem cell companies have now shifted their focus into the promising field of exosome research.
1 Kuriyan, A. E., et al. Vision Loss after Intravitreal Injection of Autologous "Stem Cells" for AMD. New England Journal of Medicine 376, 1047 (2017)
2 Andaloussi, S. E. L., Mäger, I., Breakefield, X. O., & Wood, M. J. A. Extracellular vesicles: biology and emerging therapeutic opportunities (https://www.nature.com/articles/nrd3978). Nature Reviews Drug Discovery 12, 347 (2013)
3 Phinney, D. G. & Pittenger, M. F. Concise Review: MSC-Derived Exosomes for Cell-Free Therapy. Stem Cells 35, 851 (2017)
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Exopharm Limited is an Australian regenerative medicine biopharmaceutical company which is listed on the Australian Securities Exchange seeking to develop and commercialise exosomes as therapeutic agents – initially a product called Plexaris™ and later a product called Exomeres™.
These products are exosomes that are derived from human platelets in relation to Plexaris, and adult stem cells in relation to Exomeres, and purified using the LEAP Technology (https://exopharm.com/the-power-of-exopharms-lea...) and referred to as biologic products.
As its primary focus, Exopharm aims to be a leader in the field of human therapeutics using exosomes as regenerative medicine products for health span related conditions.
Dr Ian Dixon
+61 03 9111 0026
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