Veterinary Cell Based Therapies

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

• Veterinary Stem Cells
• Veterinary Progenitor Cells
• Veterinary Cellular Cancer Therapies
• Amniotic Derived Cellular Therapies

Veterinary cell based therapies that are intended to modulate the immune system may be regulated by the United States Department of Agriculture – Animal and Plant Health Inspection Service.  Should the product’s primary mode of action be immune modulatory or stimulatory in nature, then  these veterinary cell based products may be considered veterinary biologics.  If so, their development will fall under the purview of the United States Department of Agriculture – Center for Veterinary Biologics.

For instance, if a veterinary cell based product (macrophage cell line, lymphocyte cell line, CAR-T therapy, etc.) works by stimulating or modulating the adaptive immune response, then by definition this would be considered a veterinary immuno-biologic.

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Veterinary stem cells have been used for over a decade in veterinary medicine.  Several veterinary stem cell companies offer stem cell processing services, whereby the veterinarian can send in a sample of tissue (adipose, bone marrow, etc.) and the veterinary stem cell company will process these samples to extract regenerative cells.  Veterinary cell based therapies that are intended to regenerate tissue and alter the structure and function of the animal will likely be regulated by the Food and Drug Administration – Center for Veterinary Medicine.  As such, these veterinary cell based therapies would be considered veterinary drugs.  Certain companies have also developed in-house (bedside) equipment which can process autologous tissue to remove regenerative cells or create platelet rich plasma (PRP).  These cells then can be administered back into the patient versus having to send the tissue out for processing.

In 2015, the FDA-CVM published Guidance for Industry #218, providing guidance for companies and organizations which seek to study and develop veterinary cell based therapies.  This document categorized the various forms (formats) by which autologous, allogenic, and xenogenic cells are categorized.  GFI #218 states that veterinary cell based therapies are considered drugs, and therefore are subject to receiving a New Animal Drug Approval before marketing these products.

click here for more information about Guidance for Industry #218