Regenerative orthopedics is an emerging market which has been gaining popularity in the last decade. These treatments help patients suffering from soft tissue, muscle, and bone degradation by providing fresh materials for the body to reconstruct the damaged tissues. With shorter recovery periods, less invasive application methods, and a better price point, regenerative orthopedics seems to be a good alternative to current treatment methods. Recently, there has been push back from the FDA to increase the oversight, standards, and practices behind these relatively new therapies.
In December of 2017 the FDA released a “guidance document” titled Regulatory Considerations for Human Cells, Tissues, and Cellular and Tissue-Based Products: Minimal Manipulation and Homologous Use. The document provides an outline of the sorts of permissible uses of the human cellular or tissue products used in regenerative orthopedics. Moreover, this document gives potential consumers an idea of the proven medical uses of these types of products and services.
While the FDA has not approved many of the uses in practice today, they did provide a road to legitimizing the treatments in their guidance document, though it was rather rigorous and not realistic according to many in the regenerative orthopedics industry.
Later that same year, after pushback from clinics across the USA, the FDA created a more realistic path to legitimize the therapies offered by these clinics. Whereas previously, these treatments would have had to undergo several rounds of clinical trials over the course of some years, the new path allows clinics to pool their data and present these results to support the claims they make about their therapies.
This new research on stem cells and regenerative orthopedic medicine has shown tremendous promise. Over 700 clinical trials are underway at the moment across the US, with several thousand more happening across the globe. As these trials continue, emerging data suggests that a wide majority of these therapies are successful at treating the underlying causes of patients’ issues, not just reducing the symptoms. Furthermore, the data from these trials is beginning to give regenerative orthopedic clinics a better idea of the standards and practices they should be following, giving patients safer, more responsible treatment options.
As this data continues to flood in from across the US, consumers should expect to see not only better treatment options, but hopefully insurance coverage for these treatments as well. With fewer complications, less downtime, and a lower price point, these therapies could shake the foundation of current insurance policies. As of yet, only those in professional sports seem to have access to these therapies as a part of their insurance plans. As the FDA legitimizes these therapies, hopefully we will see more insurance companies following suit.
Regenerative orthopedics is still an emerging market. Many clinical trials are underway and the path to permissible use keeps expanding. FDA regulations and insurance company approval seem to be the only thing standing in the way of these radical new treatments becoming the norm. As more data emerges, hopefully we will see better treatments, standards, and practices come about for regenerative orthopedics. If you are interested in having these procedures performed it is imperative that you do your research with the clinic or physician. A minimum of 5 years of experience if often required by the physician to understand the benefits, results and potential complications.