As the basketball frenzy that accompanies March Madness draws to the fever pitch of the Final Four, it brings to mind that basketball is a high contact sport. A quick peek at the NBA injured list reveals a catalog of breaks and tears that affect tendons, ligaments and bones.
The pressure to improve performance and search for quick recoveries has led some celebrity athletes to seek out stem cell treatments overseas and in the U.S. Among NBA players to get stem cell treatments are Jason Kidd, Tracy McGrady, Amaré Stoudemire, Allan Houston and Kenyon Martin, according to a Sports Illustrated article.
They underwent microfracture surgery to extract mesenchymal stem cells from bone barrow to repair damaged tissue. Although the practice of high-profile athletes seeking this treatment has grabbed a lot of headlines, it’s not the kind of publicity that helps stem cell medicine in the country says Dr. Jason Dragoo, a Stanford University School of Medicine orthopedic surgery and sports medicine professor.
Dragoo said in a phone interview that the publicity has actually had a negative impact on the development of clinically proven stem cell therapies for orthopedic medicine and how it is perceived. “Because of this market pressure, private clinics have been offering stem cells treatments both here in the USA as well as around the world. Often, these treatments have not been studied and are not regulated in any way. FDA [U.S. Food and Drug Administration] regulations have also severely limited new clinical trials in stem cell therapy in the USA.”
The ethical debate of using embryonic stem cells taken from fetuses has been sidestepped to some extent by the viability of adult stem cells for stem cell therapy. Although the FDA permits cells being extracted from individuals and transformed into stem cells, and re-inserted back into the same person, it requires that the conversion involve no more than water, preservatives and storage products. Anything more than that, the FDA policy states, would be classified as a drug therapy and need to go through the proper application protocol.
But a much-awaited decision by the U.S. District Court in Washington, D.C. expected in May that may resolve a four-year-old battle between the FDA and Regenerative Science in Colorado could represent a sea change in how autologous adult stem cell treatments are regulated. The FDA is seeking to prevent the company from providing autologous adult stem cell treatment for musculoskeletal and spinal injuries. If the FDA were to lose, anyone with a medical license could develop autologous stem cells and inject them back into patients, without any regulatory oversight, according to a Cell Press article.
Although stem cells are the focus of numerous clinical trials, they are mainly for cancer and rare diseases, most are being conducted outside the United States. While there have been some developments for sports medicine applications produced by research from academic institutions, there have been no clinical trials for stem cell treatments in sports medicine in the United States because of the FDA’s reservations about using adult stem cells. Despite the laxer regulations in Japan, China and Europe, it’s not in the financial interest of companies there to spend the money to do clinical trials if they don’t have to.
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
Among the most interesting applications for orthopedic medicine are the restoration of articular cartilage and patching defects in joint cartilage, with the hope of resurfacing arthritic joints in the future, Dragoo said. Stanford is preparing to initiate its own clinical trial next year looking at inducible stem cells.
“This technique takes adult cells and makes them young again by inserting four genes, which makes the cells immature and allows them to be directed into different types of tissues,” Dragoo said.
“There are a lot more trials for the use of stem cells for diseases that are fatal or nearly fatal because there are no good answers,” Dragoo said. “That’s totally different than a young healthy athlete who is trying to improve their performance or recover from an injury. It’s a very different feeling than someone battling a disease like cancer and the FDA has encouraged clinical trials to develop compassionate use of stem cells. Orthopedic medicine is a much lower priority.”
[Flickr photo from mvongrue]
