EVs open up an entirely new way to harness the regenerative and anti-inflammatory characteristics of MSCs without using the cells. Aegle’s founder Dr. Evangelos Badiavas and his team spent decades researching clinical applications for mesenchymal stem cells (“MSCs”) in severe dermatological disorders, including conducting a clinical trial to treat burn patients with MSCs at the University of Miami (ID: NCT02104713). In this trial, ten patients with severe second-degree burns were treated with two doses of MSCs. All patients experienced accelerated healing, little to no scarring, re-pigmentation, hair growth and skin elasticity. The two patients with the largest burns experienced healing rates of twenty-six cm2/day. However, it is well documented that the behavior of MSCs is difficult to predict and/or control in vivo. They are also a challenge to dose and can engraft, proliferate, and differentiate in the body. As part of the MSC trial, the secretome of the MSCs was analyzed and shown to contain hundreds of billions of extracellular vesicles in a single dose. Dr. Badiavas was early to propose that the mechanism of action of stem cells are the extracellular vesicles secreted by the cells.

Aegle is developing therapies for severe diseases using EVs isolated from allogeneic bone marrow derived MSCs. Aegle believes its platform technology can be used to develop therapies in a number of therapeutic areas including dermatology, immune-oncology, CNS and Aegle’s Platforms. Adult human MSCs secrete EVs naturally and continually. The EVs function as the paracrine wound healing mediators of their parent cells. EVs express membrane proteins and contain mRNA, miRNA, high-molecular DNA, peptides, proteins, and metabolites of their host cell of origin. EVs transport their cargo and fuse into target cells, delivering the messages of the host cell, and alter the function and physiology of the target cell. Like stem cells, extracellular vesicles stimulate and enhance neuronal regeneration, cellular proliferation, cellular migration, and functional regeneration and organization of complex tissue structures in vivo. EVs have also been shown to deliver missing genetic material to diseased or damaged cells, correcting the functionality of the cells. Since extracellular vesicles are not “living” like cells they do not migrate, differentiate, proliferate or engraft, addressing some of the more complex issues surrounding stem cell therapy.