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Company Claims Exosomes Are "Next Big Thing" After Stem Cell Therapy.

MELBOURNE, Australia, July 17, 2019 -- The exosomes (extracellular vesicles) released by stem cells "may be the disruptive therapy for tackling age-related diseases doctors and patients have been waiting for," according to Ian Dixon, managing director of Exopharm (Melbourne, Australia), a company founded in 2013 whose LEAP technology provides "a key step in the downstream manufacturing process to isolate and purify exosomes from adult stem cells and other sources."

Dixon said that despite the promise of stem cell technology, after 20 years "the general safety and efficacy of stem cell therapy has still not been proven."

He cites an article published on January 23, 2017 by researchers at the U.S. FDA that concluded that "cellular therapy for regenerative medicine is struggling to get approvals and to generate sales."

"Only a few allogeneic off-the-shelf cellu lar therapies have been approved for sale world wide for regenerative medicine, despite huge in vestments," Dixon said.

According to Dixon, several key issues have bedeviled stem cell technology for two decades. Among the key issues are safety and the difficulty of predicting cell behavior after injection.

These problems have not stopped unscrupulous scam artists from marketing and applying untested, unproven stem cell therapies, however.

"Some 'autologous' therapies using the patient's own cells have also become notorious in certain countries and the subject of doubtful or dangerous medical tourism," Dixon said, adding that there has been little progress toward FDA-approved clinical use of stem cell-based therapies.

"Little wonder, then, that regenerative medicine researchers are increasingly turning to exosomes: packets of beneficial biomolecules released by stem cells."

The Exosome Answer And Exopharm 's Role

According to Dixon, the working hypothesis for how stem cells exert their regenerative effects was wrong because transplanted stem cells don't stick around long in the recipient's body to replace damaged cells. "Most are cleared within a week."

Dixon cites researchers who have concluded that "it's the exosomes stem cells release, rather than the cells themselves, that impart the regenerative benefit."

"Exosomes," Dixon said, "are being described as the 'secret sauce' of stem cells. 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."

Dixon said:

"But while stem cells secrete trillions of exosomes naturally, efficient separation and purification of exosomes has proven to be very difficult indeed. Until now.

"Exopharm's proprietary LEAP technology is a robust and reliable method for producing a well-defined set of proprietary pharmaceutical grade exosome product as a next-generation cell-free regenerative medicine."

Citation: Marks, P.W. et al., Clarifying Stem Cell Therapy's Benefits and Risks. New England Journal of Medicine 376, 1007 (2017), DOI: 10.1056/NEJMp1613723


Contact: Robert M. Califf,

Contact: Ian Dixon,,

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Title Annotation:Advanced Stem Cell Research
Publication:Stem Cell Research News
Geographic Code:8AUST
Date:Jul 29, 2019
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