- What are stem cells and cell and tissue products?
- Why are stem cell products or other ACTPs of interest to me as a pet owner?
- Are animal stem cell products and other ACTPs regulated by FDA?
- Are products made from my own pet’s cells or tissues regulated by FDA?
- Are there any FDA approved stem cell products or other ACTPs available for animals?
- How are stem cell products and other ACTPs made?
- What is FDA doing to control unapproved stem cell products and other ACTPs?
- What should I do if my pet has a problem after receiving a stem cell product or other ACTP?
- Can my pet participate in a clinical study and receive a stem cell product or other ACTP?
What are stem cells and cell and tissue products?
The FDA refers to products that are made from, or consist of, cells or tissues for use in animals as animal cells, tissues, and cell- and tissue-based products (ACTPs).
Stem cell products are one example of an ACTP. Stem cells are cells with the ability to differentiate into various cell types. Although stem cell products are perhaps the most widely known ACTP, there are many others including amnion-based products, platelet-rich plasma, and autologous conditioned serum.
Why are stem cell products or other ACTPs of interest to me as a pet owner?
Human and veterinary medicine practitioners, pharmaceutical companies, and consumers are interested in stem cells and other cell and tissue products due to their potential to treat various diseases and conditions. However, these products have not yet been shown to work or be a safe treatment option. Currently, these products can only be used for animals in investigational studies.
Are animal stem cell products and other ACTPs regulated by FDA?
Cell-based products, including ACTPs, that are intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease or that are intended to affect the structure or any function of the animal generally meet the definition of a new animal drug, and are regulated as new animal drugs. During the approval process, FDA evaluates the product’s safety, effectiveness, manufacturing, and labeling.
Are products made from my own pet’s cells or tissues regulated by FDA?
Generally, a product is regulated by FDA if the product is intended to diagnose, cure, mitigate, treat, or prevent disease in animals or if it is intended to affect the structure or any function of the recipient animal whether or not the product is made from your pet’s own cells or tissues (autologous) or those from another animal.
Are there any FDA approved stem cell products or other ACTPs available for animals?
At this time, there are no FDA-approved ACTPs for use in animals. You can find out if a product is approved by using FDA’s online searchable database, Animal Drugs @ FDA.
Unapproved products may not meet FDA’s standards for safety and effectiveness. Unapproved products also may not be properly manufactured or properly labeled. Without FDA review, these products have unknown safety and effectiveness and may pose a risk to animal and human health.
Safety concerns associated with unapproved stem cell products and other unapproved ACTPs include transmission of diseases from donor animals to the recipient animal or humans handling the product, serious and life-threatening infections related to contamination of the product, pain, swelling and inflammation due to an inflammatory reaction to the product, and hypersensitivity reactions including anaphylaxis and death.
How are stem cell products and other ACTPs made?
The specific cells or tissues collected and processed depend on the product. Common cells or tissues collected to create stem cell products or other ACTPs include blood, fat, and bone marrow. The cells or tissues collected may be minimally or markedly processed following collection. For example, to produce some products, the cells are grown in culture for several generations in order to both isolate the cell of interest and multiply the cells to produce more doses than could be made from the originally collected tissue sample. The specific manufacturing process used to create a given stem cell product or other ACTP is evaluated by FDA as part of the drug approval process.
What is FDA doing to control unapproved stem cell products and other ACTPs?
FDA supports the development and approval of innovative products to enable availability of products that are safe, effective, and properly labeled. As part of this effort, FDA oversees the industry by developing and issuing regulations and pursuing regulatory and enforcement actions, as warranted, in collaboration with our federal and state regulatory partners. FDA also issues guidance documents and provides education and training. FDA has issued warning letters to companies for marketing ACTPs without approval (see “Regulatory Actions” on the Cell and Tissue Products for Animals webpage).
What should I do if my pet has a problem after receiving a stem cell product or other ACTP?
In the event that your pet experiences a problem following administration of any FDA-regulated product, contact your veterinarian. After resolution of the event, we encourage you or your veterinarian to fill out and send in an adverse event report to the FDA. To report an adverse event for unapproved products, visit https://www.fda.gov/reportanimalae for information on how to complete and submit Form FDA 1932a, “Veterinary Adverse Experience, Lack of Effectiveness or Product Defect Report”. Adverse event reporting helps FDA monitor product safety. You are also encouraged to report any problems to the manufacturer or distributor shown on the label.
Can my pet participate in a clinical study and receive a stem cell product or other ACTP?
As part of the approval process, clinical studies are conducted to collect data to demonstrate the safety and effectiveness of an ACTP. Often, client-owned animals participate in these studies. You and your veterinarian can find information on ongoing and upcoming clinical studies evaluating investigational ACTPs in FDA’s Center for Veterinary Medicine’s ACTP Clinical Field Study Listing. The studies listed on this webpage are investigational, and the ACTPs are not FDA approved. This means the safety and effectiveness of the ACTP is not yet determined.