Development of cGMP-compliant manufacture of activated eCB-MSCs along with in vivo evaluation
Research into equine stem cells as regenerative medicine has been ongoing for over 20 years. Stem cell technologies hold promise for healing musculoskeletal tissues and wounds, fighting bacterial infections, and treating inflammatory conditions, but definitive evidence of the safety and therapeutic efficacy of these technologies have not yet been proven. A major limiting factor for conducting clinical trials to prove safety and efficacy is the lack of sufficient cell numbers with reproducible, standardized, and characterized properties. These studies build on our published work using 2D culture as well as small scale bioreactors for equine stem cell expansion. We will develop robust protocols for the scale-up of equine stem cells in both 2D culture and large commercially available bioreactors under current Good Manufacturing Practice (cGMP) conditions. This project will allow eQcell™ to explore the feasibility of using equine stem cells as treatment for joint defects. Successful completion of this project will generate pivotal data to support cGMP-compliant manufacture of equine stem cells as well as clinical evaluation of these cells for the treatment of horses with bacterial infections such as septic arthritis.