Focus on cell-free approaches offers expanded therapeutic potential for regenerative medicine applications.
Kimera Labs Inc, a specialty contract research organization, today announced the creation of a 6,000 sq ft, ISO:9001 certified exosome production facility in Miramar, Florida. As an FDA registered tissue facility, Kimera Labs Miramar will produce tissue specific mesenchymal stem cell derived exosomes as well as the Amnio2x amniotic fluid derived product for orthopedic, cosmetic and regenerative medicine applications.
“In many cell-based therapeutic applications, long distance paracrine signaling via microvesicles is emerging as the primary mode of action for tissue regeneration,” said Duncan Ross Ph.D., President of Kimera Labs. “With over 300 growth factors and thousands of nucleic acids, the KM300 series of exosomes is a frozen, off the shelf solution to inflammatory disease and tissue dysfunction. With the clear functionality of our topical XoGlo product for skin quality enhancement and recovery after cosmetic procedures, it is clear that seeing is believing when exosomes are employed in the clinic.”
Since the first application of XoGlo for dermal recovery in a second degree burn victim in October of 2014, Kimera Labs has been refining the proprietary production process of the KM300 series of exosomes to maximize efficacy and safety. With intellectual property filings completed, Kimera will move towards IND filing in 2017 for KM300 usage in orthopedic applications, while supporting the distribution of the twice concentrated amniotic fluid product: Amnio2x.
Kimera Labs will be hosting an information session regarding exosomes and fibrin scaffolds at the Miramar lab on Dec.10th, 2016, one day following the close of the World Stem Cell Summit in West Palm Beach.
About Kimera Labs
Kimera Labs is a privately held FDA registered tissue facility based in South Florida. Kimera Labs follows cGMP production procedures and the facility holds both ISO 9001 and ISO 13485 quality control certification for the production of medical devices. For more information visit kimeralabs.com.
Exosomes are secreted microvesicles consisting of an approximately 100nm bi-layer lipid membrane containing protein, messenger RNA, and microRNA payloads specific to the cell type of origin. Exosome sources include mesenchymal stem (stromal cells), regulatory T cells, and other cell types. Exosomes are currently being investigated for both therapeutic and diagnostic purposes and are regulated as a 351 tissue product by the Food and Drug Administration.
Source – PR Web