Pet Stem Cell Therapy Investigation

Pet owners looking for treatment options for an injured or aging animal may be offered pet stem cell therapy as an alternative to more traditional treatments. The therapy is marketed for conditions including osteoarthritis and certain tendon and ligament injuries. Some providers describe the treatment as a way to reduce pain or help damaged tissue repair itself.

The treatment has been the subject of scientific research, but questions remain about how well the available evidence supports some of the promises and claims some vets may provide. Concerns about veterinary stem cell fraud have also drawn increased attention from consumers and regulators.

One prominent company operating in this field is VetStem, and they bill themselves as a “leader in regenerative veterinary medicine.” According to information published on its website, VetStem stem cell therapy processes cells taken from a pet’s own fat and returns the processed cells to the veterinarian for injection.

The company describes its regenerative cell therapy as being used for conditions including osteoarthritis and certain orthopedic injuries. VetStem also publishes information about clinical research and treatment outcomes involving veterinary patients.

The existence of published research does not necessarily establish that every stem cell treatment will work for every animal, however. The particular cells used, how they are processed, how they are administered, and the condition being treated can all affect the results.

Contact The Lyon Firm to learn more about consumer protection law and stem cell fraud cases, or to learn more about your legal rights. Our attorneys are investigating pet stem cell fraud on behalf of plaintiffs nationwide.

What Does the Scientific Evidence Show?

There is evidence that some stem cell treatments may provide benefits for certain veterinary conditions.

For example, a 2016 study examined adipose-derived stem cells dogs with osteoarthritis. The study included 74 dogs in its efficacy analysis. Researchers reported statistically significant improvements in several outcome measures among treated dogs compared with dogs that received a saline placebo. The measures included owner assessments as well as veterinary evaluations.

That study provides evidence of a potential benefit, but it does not establish that all stem cell treatments are effective or that an individual animal will respond to treatment.

A systematic review of adipose-derived stem cell treatment for canine osteoarthritis stem cell therapy also reported positive clinical effects in the studies it examined. At the same time, the researchers noted substantial differences among the studies and found moderate to high risk of bias in the randomized trials and high risk of bias in the before-and-after studies. The authors concluded that larger studies using standardized protocols were needed.

Another review examining intra-articular allogeneic stem cell therapy for canine osteoarthritis reached a similar conclusion. It found evidence of reductions in pain and lameness compared with placebo but classified the overall strength of the evidence as weak. The review also noted that the outcome measurements used in the studies were largely subjective.

These limitations are important for consumers considering expensive measures to treat their animals’ conditions. Evidence is mixed and does not uniformly establish that a particular product will produce a positive result in a particular pet.

The FDA’s Position on Pet Stem Cell Treatments

The FDA refers to animal cells, tissues and cell-based products as animal cells, tissues and cell- and tissue-based products, or ACTPs. The agency says most ACTPs are regulated under the Federal Food, Drug, and Cosmetic Act when they are intended to treat disease or affect the structure or function of an animal. Those products generally require FDA review and approval before they can legally be marketed for those purposes.

The FDA currently states that there are no FDA-approved ACTPs for use in animals. The agency warns that unapproved animal cell therapy products may not have undergone FDA review for safety and effectiveness and may not have been adequately evaluated for manufacturing or labeling. This position applies directly to most forms of FDA pet stem cell treatment currently available.

There is an important distinction, however. FDA also has a risk-based review process for certain ACTPs. Following that review, the agency may determine that it does not expect an application for approval before marketing for a particular product and intended use.

The FDA’s current review list includes certain platelet and plasma products, including two products associated with VetStem. But the list does not identify any VetStem stem cell therapy as an FDA-approved ACTP.

What Are Valid Pet Stem Cell Fraud Claims?

Consumers weighing their animal’s health status with spending a tremendous amount of money may want to look at whether a statement about a stem cell treatment is supported by research involving the same product, the same type of cells, the same method of processing and the same condition affecting their pet.

Statements about expected results from practitioners also deserve careful attention. Claims that a treatment will regenerate damaged tissue, eliminate pain, restore mobility or provide a lasting improvement may require more evidence than a general statement that the treatment has shown potential in clinical research.

This does not necessarily mean that a particular company or veterinarian has made an improper claim. Rather, the relevant question is whether representations made to consumers accurately reflect the available scientific evidence and its limitations — an issue that often arises in potential veterinary stem cell fraud cases.

Pet owners considering treatment can ask their veterinarian what studies support the treatment for the particular condition. Further questions may include:
• How were the animals’ presumed improvements measured?
• What percentage of animals improved?
• How long might the benefit last?
• What additional treatments might still be necessary?

Safari Stem Cell and the FDA’s 2024 Warning Letter

A 2024 FDA warning letter involving Safari Stem Cell, LLC provides a documented example of regulatory concerns involving veterinary cell and tissue products. According to the FDA, the Texas-based company marketed its canine and feline stem cell products for conditions including arthritis, intervertebral disc disease, chronic kidney disease, diabetes, inflammatory bowel disease and dry eye.

The agency determined that the products were being marketed as unapproved new animal drugs. The Safari Stem Cell FDA warning letter also identified statements on Safari’s website and social media accounts concerning the expected results of treatment. According to the warning letter, promotional materials claimed that stem cells could “regrow cartilage,” regenerate kidney tissue and “reset” a pet’s immune system.

The agency also cited statements concerning diabetes that suggested treatment could eliminate the need for daily insulin injections. Other claims involved restoring function in animals with spinal conditions.

This FDA action does not mean that every veterinary stem cell therapy is ineffective or that every consumer who purchased a pet stem cell product has been deceived. But it does provide a documented example of why consumers may want to look closely at the scientific evidence and representations made about veterinary stem cell treatments.

Have You Paid for Pet Stem Cell Treatment?

Pet owners who believe they were given misleading information about a stem cell treatment and its expected results may want to have their situation reviewed.

If you believe you were given information about a stem cell treatment that did not match your experience, you may want to preserve any advertisements, website pages, brochures, emails, treatment recommendations, invoices, veterinary records and statements describing the expected benefits of the therapy.

A consumer’s experience alone does not establish that a treatment was improperly marketed. But documentation can help establish what was represented and what happened afterward.

The legal team at Lyon Firm represents consumers in product liability and deceptive marketing matters and has experience investigating stem cell-related claims in Ohio and California and nationwide.

If you believe a veterinary stem cell product or service was not represented accurately, The Lyon Firm can review your claims and determine whether further investigation may be appropriate.

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References to VetStem, Safari Stem Cell, or any other company are for informational and educational purposes only. Mention of a company does not constitute an allegation of fraud, deception, or wrongdoing.