Interestingly, veterinary cell based therapies are regulated by either the FDA-CVM or USDA-CVB, depending on the mode of action. Those therapies which act to repair tissue would most likely be considered a “veterinary drug“, and therefore regulated by FDA-CVM. However, there are cell based therapies which are intended to stimulate the immune system and would likely be regulated by the USDA-CVB. Recently, many companies have started processing amniotic fluid containing cells for veterinary regenerative medicine purposes. Since these products are intended to repair and heal tissue, they are considered veterinary drugs.
As the veterinary regenerative medical market grows, it also provides an opportunity for translational medicine.
Volk, S. and Theoret, C. Translating Stem Cell Therapies: the role of companion animals in regenerative medicine. Wound Repair Regen. 2013 May ; 21(3): 382–394