Veterinary Stem Cells & Cell Based Therapeutics
Animal Cells, Tissues, and Cell- and Tissue-Based Products (ACTPs)
Veterinary Cell Based Immunotherapies
Veterinary Cell-Based Therapies
Veterinary cell based therapies are a rapidly emerging category in veterinary medicine and include autologous and allogeneic products. Animal cell based products are products that contain cells (e.g., veterinary stem cells, veterinary platelet rich plasma, veterinary cell based cancer vaccines) or cell derivatives (e.g., veterinary exosome and extracellular vesicle products, veterinary platelet lysates, amnion). Prior to performing veterinary clinical studies, companies should obtain a determination the veterinary cell based products classification (e.g., veterinary drug vs. veterinary biologic).
Animal Cell Based Therapeutic Drugs
Veterinary cell-based therapies which are intended to repair tissue are routinely considered a “veterinary drug” and are regulated by FDA-CVM. The FDA-CVM references these products as ACTPs, and include products containing, consisting of, or derived from cells or tissues that are intended for implantation, transplantation, infusion, transfer, or other means of administration and include animal stem cells, differentiated cells, and tissues such as blood, platelet-rich plasma, and amnion Those ACTPs intended to repair and heal tissue are considered veterinary drugs.
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. 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.
Animal Cell Based Immuno-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. More information on veterinary cancer vaccines and USDA regulations can be found on these pages.
