Celavet Equine Donor Selection Criteria Accepted by Center for Veterinary Medicine
CVM approval moves novel stem cell therapy one step closer to restoring health and mobility in horses
OXNARD, Calif., Aug. 12, 2016—Veterinary regenerative medicine start-up Celavet Inc., a subsidiary of Celavie Biosciences LLC, received approval from the Center for Veterinary Medicine (CVM) for the donor selection criteria of its equine OK100 stem cells. The Investigational New Animal Drug (INAD) file for the OK100 stem cells is proposed to treat tendinitis (e.g., tendon injuries, bowed tendons, etc.) in horses.
The CVM approved the equine donor selection and equine donor testing plan of Celavet for a novel stem cell therapy under development at Celavet and parent company Celavie Biosciences that might change the paradigm of regenerative medicine. 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.
“Approval of Celavet’s donor selection criteria marks further progress as we strive to unleash the innate healing power of our stem cells,” said Celavie Biosciences CEO and President Sandy Solmon. “Veterinary applications, like the treatment of tendinitis in horses, offer a faster path to market for our revolutionary stem cell technology.”
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.
Both Celavie 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. 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 CVM approves donor selection criteria for animal stem cell products that demonstrate health of donors and prevention of transmission of disease agents. 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.