Celavet Characterization of Cells Accepted by Center for Veterinary Medicine
Novel cells offer functional and structural restoration advantages for transplantation and therapy
OXNARD, Calif., February 21, 2017—Veterinary regenerative medicine start-up Celavet Inc., a subsidiary of Celavie Biosciences LLC, received approval from the Center for Veterinary Medicine (CVM) for product characterization of its equine OK100 stem cells. Celavet’s donor selection criteria were approved by the CVM last August. These approvals mark significant progress towards pivotal studies for the OK100 stem cells, proposed to treat tendinitis (e.g., tendon injuries, bowed tendons, etc.) in horses.
“Product characterization approval for Celavet’s equine OK100 stem cells brings us closer to changing the paradigm of regenerative medicine,” said Celavie Biosciences CEO and President Sandy Solmon. “That we can relieve suffering and restore mobility to these exquisite animals and help them achieve perfect fiber alignment by catalyzing the natural healing power of cells is powerfully motivating and inspires us daily to push ahead.”
Celavet is developing undifferentiated allogeneic pluripotent stem cell-based therapies for the treatment and prevention of orthopedic injuries and diseases in large and small animals, restoring health and mobility. Celavet’s proprietary technology is based on the hypothesis that Celavet stem cells’ pluripotential nature allows them to differentiate into multiple cell types, and rapidly restore, remodel, and renew tissues that have been damaged by trauma, or degenerative disease. The R&D team, working with veterinary scientists at centers across the country, is accumulating evidence that Celavet stem cells are hypo- or non-immunogenic and do not cause an immune response.
Celavet’s research and development program is based on fundamental discoveries made by its scientific team over the past 14 years. Celavet is in a unique position to benefit from the developmental breakthroughs in human stem cell technology achieved by its parent company, Celavie Biosciences. Celavet has refined and repurposed its technology in order to develop stem cell applications for the veterinary marketplace. Celavet is working to restore function in orthopedic conditions of large and small animals, with noticeable tissue repair observed in trials conducted on over 400 horses.
Both Celavie Biosciences and Celavet use the latest technological breakthroughs to produce large banks of undifferentiated stem cells with uniform qualities utilizing closed-system bioreactors. The cells are grown in a specialized patented medium that allows them to maintain their sterility and genetic stability over the course of the manufacturing process. Celavet uses the same standardized and controlled production methods to establish equine, canine, and feline stem cell lines as those used by Celavie Biosciences in the manufacture of human cells. Stem cell lines from different species all express standard stem cell characteristics and are available to address pathologies in their respective species.
The CVM works with the Food and Drug Administration (FDA) of the Department of Health & Human Services to foster public and animal health by assuring that safety, effectiveness and quality in animal drugs.