Overview
Veterinary cell based therapies have been used for decades in veterinary medicine. Veterinary cell and tissue based therapies are used in the fields of veterinary regenerative medicine, such as veterinary stem cell therapy. Veterinary cellular therapeutics are also used in the field of veterinary immuno-therapy.
Several veterinary cellular therapy companies offer tissue processing services, whereby the veterinarian can send in a sample of tissue (e.g., blood, adipose, bone marrow, etc.) for extraction of stem cells or for the modification of cells for immunotherapy applications such as cancer and infection. Companies developing veterinary cell and tissue based therapies must consider the differences in regulatory oversight depending on the products intended use and mode of action, briefly described below.
ACTPs (Animal Cells, Tissues and Cell- and Tissue-Based Products)
ACTPs include:
-Stem cells (including those consisting of mesenchymal stem cells, induced pluripotent stem cells, or embryonic stem cells);
-Precursor and progenitor cells;
-Differentiated cells;
-Stromal vascular fraction;
-Bone marrow aspirate concentrate;
-Amnion, amniotic membrane, and/or amniotic fluid;
-Whole and homogenized tissues;
-Blood and blood-derived products (such as platelet-rich plasma and autologous conditioned serum);
-Conditioned media; and
-Exosomes
Veterinary Regenerative Medicine
Veterinary Cell Based Immunotherapy
In 2015, the FDA-CVM published a guidance for industry document indicating that veterinary cell based therapies are considered drugs, and therefore are subject to receiving a New Animal Drug Approval before marketing these products. 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 if they meet the definition of a veterinary drug. 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.
In cases where the veterinary cell based therapy’s intended use and primary mode of action is to stimulate the patient’s immune system against cancer (e.g., cancer immunotherapy, adoptive cell therapy) or infection, these veterinary products may be classified as veterinary biologics and 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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