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As the field of regenerative medicine evolves, and new therapeutics are being brought to market, DynaCord is committed to the development of safe and regulated MSC exosome products.
DynaCord is the first biologics lab in the United States to obtain a Masterfile with the FDA for MSC exosomes. As a result, this Masterfile can be referenced and used in medical research where DynaCord MSC exosomes are utilized.
This Masterfile allows for the sale of DynaCord MSC Exosomes for research purposes.
Stem Cell Derived exosomes have been shown to be efficacious in several 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, helps with injured ligaments/tendons, osteoarthritis, bone regeneration, and vaginal rejuvenation.
Currently DynaCord has the only FDA master file acknowledged exosome products available in the US.
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.