Regenerative medicine

Comment on this policy

Regenerative medicine includes the use of biological therapies to regenerate or replace cells that are injured, diseased, or defective to restore normal function. These therapies include orthobiologic therapies, stem cell, cell-based, and gene editing therapies. Some examples include serum or plasma products and stem cell products to effect therapeutic benefit in disease states. While regenerative medicine holds promise of improvements in the treatment of a variety of diseases, many of which lack adequately effective treatments, questions remain. The AVMA supports the continued scientific development of these modalities while at the same time encouraging its members to employ caution with respect to their use.

While data continue to accumulate suggesting therapeutic benefit from regenerative medicine, published peer-reviewed studies definitively documenting benefit or safety are still lacking for many diseases. Nor has a scientific consensus for effective treatment regimen including indication, route of administration, dosing frequency, duration or technique been developed. Despite these scientific insufficiencies, the adoption of regenerative medicine in the veterinary profession has grown rapidly. Some therapies being propounded and the processes and equipment being sold have outpaced the science that supports them. Veterinarians have few guidelines and limited resources for differentiating valid and effective therapies from those that have insufficient data support. Therefore, it is incumbent upon veterinarians engaged in regenerative therapies to be well versed in and contribute to the emerging science of the field in order to successfully select the specific therapeutic protocols, processes, equipment, and vendors most likely to result in clinical benefit for their patients.

Use of regenerative medicine by veterinarians should include the following considerations:

Regenerative therapy protocols should ideally be formulated using evidence-based medicine. Veterinarians must balance the evolving nature of regenerative medicine protocols with the emerging evidence supporting the efficacy of these treatments. Veterinarians should discuss the risks and benefits of such protocols; in particular, those for which benefit has not been demonstrated in peer-reviewed literature in the target species, and communication as such to the client should be documented.
Regenerative therapies should be used in compliance with FDA Guidance for Industry #218 (GFI #218). Veterinarians engaged in the use of regenerative therapies should be well familiar with the contents of this document in order to best assess the many therapeutic systems, products, and procedures available and ensure compliance with the regulations for their use. Careful attention should be given to the definitions in GFI #218 of autologous Type I, autologous Type II, minimal manipulation, and homologous versus nonhomologous use, as these largely encompass the current enforcement priorities of the FDA with regard to regenerative therapies.
Regenerative therapies should utilize systems, equipment, and processes that have been adequately validated and demonstrated to be safe. The use of systems without such validation poses unnecessary risk to the patient, compromises treatment successes, impedes collection of therapeutic data, and exposes the attending veterinarian to potential liability.
Collection, preparation, processing, activation, and administration of regenerative therapies and related biotherapies should be performed under a strict aseptic technique following species-specific validated protocols and employment of adequate quality control measures.
Donor eligibility should be appropriately considered, including screening for infectious diseases, according to GFI 254 (Donor Eligibility for Animal Cells, Tissues, and Cell- and Tissue- Based Products).
Laboratories selected to process, characterize, culture, tissue culture expansion, or bank stem cells in order to provide any stem cell or regenerative services should be experienced, equipped, and staffed with personnel proficient in the handling and processing of stem cells using species-specific validated protocols with quality control measures and should comply with all laws and regulations governing the use of cell-based products.
Veterinarians who engage in processing of cells in the hospital may be considered by the FDA to be a manufacturer with all the attendant manufacturer requirements including maintenance of current Good Manufacturing Practices as stated in GFI 253. Therefore, systems should be in place to ensure adequate operator training and validated lab procedures that allow assessment of cell type, viability, quantity, morphology, and sterility when appropriate. Additionally, if considered a manufacturer, the veterinarians must be aware that they, and not the medical device equipment vendor, assume liability for any and all adverse events associated with cell products and therapies.
Of the regenerative therapies or Animal Cell and Tissue-Based Products (ACTP’s), only autologous Type II (minimally manipulated autologous products for homologous use in nonfood animals) or risk reviewed regenerative therapies that are only reviewed for safety should be utilized in clinical cases based on the guidance of GFI 218 unless and until FDA approval has been achieved. AVMA encourages veterinarians to be aware of ongoing clinical studies posted by FDA. Use of USDA-licensed or FDA-approved products is preferable if available.
In client communication, advertising, or websites, veterinarians engaged in the use of regenerative medicine and vendors of cell products, equipment, laboratory services, and processes should refrain from making claims that are not fully supported by peer-reviewed, published data.
Practitioners engaged in the use of regenerative therapies should be fully apprised of the potential for liability not fully covered by their professional liability insurance.