Regenerative
Solutions

Manufactured in compliance with 351(a) and GMP requirements

Regulatory

Current Regulatory Aspects of Exosomes and Regenerative Medicine

We have sourced a line of exosomes which have been manufactured in accordance with current regulatory guidelines under 351(a). These more stringent regulations require more research and clinical trials.

All testing for these products is performed on a batch by batch basis by third party laboratories and the manufacturing processes for the product has been reviewed by appropriate regulatory agencies. As a result our products are able to be purchased for any independent research or investigational purposes. Additionally, we are working with our manufacturer to seek a drug approval via an Investigational New Drug Application so that our products may be used and billed for specific clinical indications. There are currently no clinically approved exosome products in the US.

What are Exosomes

Exosomes are small vesicles released by all cells which contain proteins, lipids, and nucleic acids. Our manufacturer has isolated a sub-class of exosomes produced by MSCs which have a unique structure. As a result of their unique structure these exosomes are able to find and bind to damaged tissues and sites where high levels of inflammatory markers are present. These exosomes contain large amounts of growth factors, cytokines, and other substances known to impact inflammation and regenerative processes. The exosomes use their structure to fuse with other cells in the body and release their contents. By transferring signaling molecules, the contents of these exosomes can have drastic impacts throughout the medical field. As opposed to stem cells, exosomes cannot replicate, they don't contain DNA, and they don't elicit an auto-immune rejection response, making them a safer product. Cell-free exosome products don't contain any live cells by definition.

The Evolution of Stem Cell Derived Exosomes

Products

MSC Exosomes

How do they Work?

Exosomes derived from stem cells have been shown to be the source of healing in stem cell treatments. The process of stem cell products healing the body consists of: Injured tissues release 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 an exosome > the exosome attaches to the site of injury > the exosome releases its contents to the injured tissue healing it.

Live stem cells are highly regulated due to the inherent medical risks and limited efficacy associated with them. The only way live stem cells can currently be used for tissue transplantation is if they come directly from the patient or are not manipulated in any way. Using live stem cells currently has major limitations beyond the health risk.

As a first point, any tissue used for transplantation is only compatible with similar tissues (for example, placental membranes are limited to use as a membrane between a fetus and mother). Secondly, stem cells derived from oneself can be degraded over time as a result of aging. People's stem cells begin to lose their effectiveness when they reach the age of 40. Stem cells are hardly effective after the age of 60, when most patients need these treatments.

Our exosome provider’s solution is to use a newborn's umbilical cord and extract the stem cells from the Wharton's Jelly within. This allows them to use the newest and most powerful stem cells available. They are only grown out to the third passage, maximizing their efficacy in exosome production. Once they have immersed them in the appropriate medium, they are able to secrete exosomes. Those exosomes are then extracted and used in finished products.