Stem Cell Derived Exosomes


Exosomes are small vesicles that are secreted by stem cells. They contain large amounts of growth factors, cytokines and other substances with high regenerative potential that can be transferred to other cells due to their unique structure. This structure allows the exosomes to fuse with other cells in the body and to release their content into other cells. The contents of the exosomes such as cytokines, growth factors and mRNA can then help the cell heal itself due to the actions of the transferred signaling molecules. Contrary to stem cells, exosomes do not replicate, do not contain DNA and do not elicit an immune response, resulting in a safer product compared to stem cells. By definition, exosome products are cell free and do not contain any live cells.
Stem cell derived exosomes have been shown to be the source of healing in stem cell treatments. The process for which stem cell products heal the body is as follows: An injured tissue releases chemical markers signaling their damage > a stem cell absorbs these markers and creates the appropriate components for healing the tissue > the stem cell packages these components into a vesicle called an exosome > the exosome goes to the site of injured tissue and attaches > the exosome releases its contents to the injured tissue, healing the tissue Stem Cell derived exosomes have been shown to be efficacious in a number of studies related to repair of peripheral nerve damage, traumatic brain injury, accelerated wound healing and bone fusion, tissue repair, anti-inflammatory effects, skin regeneration, cartilage regeneration, treatment for injured ligaments/tendons, osteoarthritis, bone regeneration, and vaginal rejuvenation. Despite these reported effects of exosomes, there are currently no FDA approved exosome products available in the US.


Current Regulatory Aspects of Stem Cell and Exosome Treatment

Compared to stem cells, the exosome treatment is cell free and therefore represents a low-risk treatment compared to stem cells. Studies have shown that treatments with exosomes show similar or better results when compared to stem cell treatment. Based on this information, it is thought that stem cell treatment facilitates its beneficial effects through the secretion of exosomes rather than effects of the stem cells themselves. By using exosomes directly, we can eliminate the injection of stem cells which is known to cause potential issues during treatment.


Due to the high medical risks of using live stem cells, they have been highly regulated. Currently, the only legal way to use live stem cells is if they are derived from the patient themselves or are not manipulated in any way and used as a tissue transplant. These current methods of using live stem cells have major shortcomings beyond the health risk. First, any tissue that is used as a transplant is limited in its application in only being able to be applied to similar tissue (placenta membranes may only be used on similar skin type tissues). Second, any self derived stem cells are subject to degradation due to aging. At the age of 40 a person’s stem cells begin to lose effectiveness. By the age of 60, the age of most patients needing stem cell treatments, the stem cells are barely effective, if at all. We combat this by using an umbilical cord from a new birth and extracting the mesenchymal stem cells. This allows us to use the newest and most potent stem cells possible. We then screen and culture them in a lab to control safety and efficacy of the cells. We then immerse them in the appropriate medium which allows them to secrete exosomes with consistent and high quantities of regenerative factors. Finally we extract the exosomes and analyze them through batch testing at which point they are made available for research purposes.

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