Introduction

Regenerative stem cell therapy (RSCT) clinics are allowed to operate in the United States within the limits described in section 361 of the Public Health Services Act (PHSA-361). The clinics use procedures that are not FDA approved or proven to be effective at treating any medical condition and claim to be operating within a “physician’s right to practice medicine.” RSCT clinics claim to treat various conditions such as Alzheimer’s disease, multiple sclerosis, diabetes, and even HIV. Treatment costs vary and are from $7,000 to $10,000. Treatment is not covered by insurance. RSCT consists of removing fat tissue by liposuction, processing the tissue to extract a small stem cell containing portion called the stromal vascular fraction (SVF), and finally injecting the SVF back into the same patient. The process takes less than 1 day.

Background

Therapies using tissues, such as mesenchymal stem cells used in RSCT clinics, are allowed under the PHSA-361 as long as the tissues are not excessively processed, are used in the same person they came out of, function as originally intended, and are not combined with active or harmful chemicals. Non-FDA approved RSCT became available once it was discovered that fat removed during liposuction contained a type of stem cell called mesenchymal stem cells. These cells were then successfully cultured in the lab, using various stimulating factors, and manipulated to mature into different types of tissues:  bone, cartilage, muscle, and nerve. Research is ongoing to test the applications of mesenchymal stem cells in various human diseases.

Non-FDA approved therapy using SVF has been under much scrutiny by medical professionals who claim SVF does not meet the criteria in PHSA-361 and is actually a biologic drug and requires FDA approval. To answer questions about individual tissue products, the FDA created the Tissue Reference Group to decide which tissue products to declare as biologic drugs that require FDA approval and which products could be used without FDA approval under PHSA-361. The Tissue Reference Group stipulated that mesenchymal stem cells from fat tissue were not protected by PHSA 361 when used for regenerating bone. The group did not state that mesenchymal stem cells from fat could not be used for other things according to PHSA-361.

The Federal Trade Commission Act (FTCA) prohibits false or misleading advertising and treatments such as RSCT are considered a drug by definition of the FTCA. In general, advertising cannot be misleading and it must reveal all consequences of using the product.

Issue

Does advertising by commercial regenerative stem cell therapy clinics violate the Federal Trade Commission Act?

Rule

RSCT clinic advertising does not violate the Federal Trade Commission Act If RSCT advertising by company websites is not misleading AND the risks of therapy are fully disclosed.

Analysis

Misleading Advertising

Looking at a rejuvenative stem cell therapy clinic website for example, the website is free from written statements declaring RSCT effectiveness and they have a disclaimer in a discrete location that states the therapy at the clinic is not FDA approved and cannot treat or prevent any diseases. The website, however, is full of search-engine-optimization (SEO) tactics such as repetitive keywords regenerative, regeneration, regenerate, renewal, and various diseases. For example, on the home page of the clinic website, there are links indicating studies for many different diseases and medical conditions, but the links go to webpages within the clinic’s own website. The page that comes up after clicking the link has abstracts of studies unrelated to the disease in the link but with a desirable keyword. These are SEO tactics to optimize the website for disease and medical condition words that are in the bogus links. Optimizing a web page for a term is a marketing technique. Advertising on the internet is not static as in paper or audio/visual methods. It is interactive. Optimizing for a search term is a mechanical way to make a website the answer to the question users ask by conducting an internet search using applications such as Google or Bing. Positioning the stem cell therapy clinic web page at the top of a list of search results for a disease indicates the web page contains information about treatment for that disease. Another example of misleading advertising using SEO is this stem cell therapy clinic that states they are conducting trials in their clinic for a list of various diseases. The main page of the website has  the words for the disease as a link to a page within the website. The page that opens up describes how the therapy being studied could help the condition. These clinics advertise by optimizing their websites for diseases that have not been declared a safe indication for treatment.

Risks of Therapy

This clinic’s website claims no adverse effects of therapy and this website claims the adverse effects are minimal. The few adverse effect that are disclosed are written with opinionated modifiers such as ‘minor’, ‘typically’, and ‘minimal’. Presentation of adverse effects in this manner is biased. Liposuction is the method all RSCT clinics use to collect the fat tissue and it carries numerous possible adverse events. An FDA website lists several liposuction procedure risks, none of these are included on RSCT clinic websites. The risks of RSCT are not fully disclosed in clinic advertising.

Conclusion:

Stem cell therapy advertising by company websites uses SEO tactics that are misleading and the risks of therapy are not disclosed, therefore RSCT clinic advertising violates the Federal Trade Commission Act.