By Maude L. Cuchiara and Kirstin R.W. Matthews
Over the past five years, several prominent athletes have been in the news touting their speedy recovery from injuries and attributing it to therapies using stem cells. Despite the support of professional athletes, these types of stem cell treatments have not been validated in clinical trials for accurate dosing and efficacy. Furthermore, clinics actively and aggressively promote these therapies in a way that implies clinical benefit though aside from patient testimonials, they do not have robust data to support their claims. The continuance of these types of therapies by for-profit clinics and endorsement by well-known professional athletes has the potential to influence the public’s perception of the safety and efficacy of the treatments. Since they have not been proven to work through the traditional US Food and Drug Administration (FDA) approval of clinical trials the impact on medicine could be high.
Prominent athletes WHO have received stem treatments for orthopedic injuries include National Football League (NFL) stars Peyton Manning, who is still playing and led his Broncos team to the Superbowl in 2014, and Terrell Owens, who has since retired. Bartolo Colón, a major league baseball pitcher, also received stem cell therapy in 2010 and afterwards became a starting pitcher for the New York Yankees despite missing several seasons due to elbow and shoulder injuries. After Manning and Colón’s treatments, articles were published by the mainstream media debating whether or not they were “performance enhancing” and effective. These three athletes all received treatments outside of the US, but several professional athletes have attended clinics in the United States as well. It is difficult to know how widespread these treatments are among athletes, however, because most athletes do not want to be named publicly due to contract obligations.
The exact treatment regimen that patients receive is also unclear. Unless the athlete publicly discloses this information, it is private in accordance with federal law overseeing patient privacy. The clinics’ websites describe their general procedures in laymen’s terms and most are fairly similar. Tissue (typically from fat or bone marrow) is first extracted from the patient. Cells are then isolated and concentrated using proprietary methods; this usually involves centrifuging, or spinning down, the cells. The cells are then injected back into the patient systemically or at the injury/disease site. From this information, it is not evident how many live cells patients receive, the percentage of cells that are actually stem cells, or if the cells migrate to or remain at the injury/disease site.
These procedures are not regulated by the FDA because they are same-day procedures and the cells are “minimally manipulated;” therefore, they are considered a standard medical procedure. Currently, stem cell therapies are permitted by professional sports associations as long as no banned substances, like human growth hormone or steroids, are used in the procedure.
Other, more extensive treatments were recently restricted in the United States. In 2012, two U.S. clinics, Regennex in Colorado and CellTex in Texas, had procedures shut down by the FDA. The clinics treated patients with cells that were isolated from a patient, grown and stored in the lab, and injected back into the patient at a later date. The FDA viewed these procedures as more “drug-like” than “minimally manipulated” and therefore fell under the FDA’s regulatory purview. The FDA’s argument was upheld in court, and as a result, CellTex and Regenexx moved these specific treatments to Mexico and the Cayman Islands, respectively, where the FDA does not have jurisdiction.
Stem cell clinics stand to gain financially with the continuation of stem cell procedures, and they actively promote their therapies online. By Googling the term “stem cell treatment,” numerous clinics pop up especially amongst the paid advertisers; these include clinics in the United States and abroad in locations with less regulatory oversight. Many of the websites have similar designs. The home page promotes the clinic’s doctors and the efficacy of the stem cell therapies is demonstrated by numerous patient testimonials for various diseases. There are links to all of the positive media coverage that the clinic and doctor have received. Furthermore, several of the clinics use professional athletes to advertise and promote their therapies. In some cases it is unclear if the athlete even received the therapy.
Unfortunately, very few websites include peer-reviewed clinical data to validate their claims. In fact, some procedures advertised by the clinics have been found to be ineffective. A recent article published in the New England Journal of Medicine demonstrated that patients receiving a procedure often targeted to athletes, platelet rich plasma (PRP) injections, showed similar results as those who obtained a placebo.
On the clinic websites, it is also difficult to find actual scientific data to support the claims made by the doctors. Much of the data is buried in the frequently asked questions sections of the websites. On one site, one of the article links is a scanned pdf file that contains no identifying information about the journal, if one exists. A large majority of the cited work is also research that has been published by the clinic itself and often includes non-peer-reviewed opinion articles. On a few sites, no links to peer-reviewed journal articles can be found at all.
The promotional nature of the websites can be viewed as ethically questionable. The websites offer the therapies as a non-invasive alternative to surgery, an attractive option, though the treatments are rarely covered by a patient’s health insurance. The use of prominent figures to support their efficacy statements can lead the public to regard these therapies as both safe and effective. Celebrities play a major role in influencing public opinion even in health issues. The benefits and risks of stem cell treatments these athletes have obtained have not been assessed via a clinical trial, and until that occurs, patients should be wary of clinics’ claims, despite the celebrity endorsement.
The field of stem cell biology and regenerative medicine holds great promise for future cures and therapies. If left unregulated, clinics promoting unverified stem cell procedures will likely taint the entire field as being fraudulent. It is critical for the progress of the field that regulators oversee new clinics advertising stem cell therapies to ensure they have clinical data to support their claims. In addition, a traditional clinical trial procedure will also help improve the therapy allowing doctors to identify the optimal dose, select the timing of the procedure and determine if other factors need to be added with the cells. Though clinical trials require a great deal of time and money, they are a necessary part of biomedical research to protect the integrity of medicine and the well-being of patients.
Maude L. Cuchiara, Ph.D., is a research scholar in science and technology policy at the James A. Baker III Institute for Public Policy at Rice University.
Kirstin R.W. Matthews, Ph.D., is a fellow in science and technology policy at Rice University’s James A. Baker III Institute for Public Policy. She is also a lecturer in the Wiess School of Natural Sciences and an adjunct lecturer in the Department of Sociology at Rice University.
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