On June 3, 2021, the US Food & Drug Administration has for all intents and purposes put an end to the domestic stem cell therapy market with this public notice. While many anticipated the regulation of insurance billed human tissue products (HTP’s), this notice goes much further now banning the use of not only HTP’s sold as elective (cash) procedures but even autologous preparations derived from bone marrow aspiration and concentration (BMAC) and autologous fat transfer.
So, if you are a regenerative medicine practice, what do you do now?
The answer is to do what many historically successful businesses before you have done – reinvent your business!
There are other drug-free, non-surgical treatment alternatives that produce highly desirable clinical outcomes, and substantial economic gain for the modern medical practice, for many of the applications in which the use of stem cell therapies are now officially banned.
One such clinical alternative is Platelet Rich Plasma (PRP). Pursuant to FDA’s 21 CFR 1271 of the Code of Regulations; Human Cells, Tissues, and Cellular and Tissue-Based Products, Autologous Platelet Rich Plasma (PRP) preparation kits that have achieved FDA clearance through the issuance of a 510(k) number are compliant. That said, certain applications of PRP, particularly when the platelets have been “activated” using a chemical agent such as calcium chloride, may be considered adulterated products that exceed the FDA’s established minimal manipulation and homologous use guidelines. Therefore, one possible option for healthcare clinics that currently rely on the use of Stem Cells and other HTP’s, is to transition to the use of non-activated PRP produced using an FDA-cleared device such as the Juventix Regenerative Medical PRP kit.
Another alternative is to look toward FDA approved medications, biologicals, and therapeutics that are all-natural, low or no risk, with little to no known drug interactions, allergic interactions, or contraindications that have been clinically proven in the peer-reviewed literature for indications that were commonly targeted for treatment with Stem Cells and other HTP’s such as Osteoarthritis (OA) of the Knee(s).
Sounds impossible right? But I assure you, it is not… A primary example that well fits this description is the category of medications known as Viscosupplements. These medications are derivatives of Hyaluronic Acid, a naturally occurring substance, that when deficient in the synovial joints can result in joint space diminution, increased friction, loss of cartilage, and other presentations associated with symptomatic degenerative joint disease. On May 28th, 1997 the U.S. Food and Drug Administration (FDA) approved the first Viscosupplement medication, Hyalgan, as a treatment option for knee osteoarthritis (OA). Since then, many additional medications in this class have been FDA approved and utilized successfully in the US and abroad.
There are also many novel medical devices that can provide relief to conditions such as Osteoarthritis of the Knee(s), for example, mechanical unloading knee braces. These devices fall into a category of devices called “Class 1”. The US FDA defines Class 1 devices as devices which are “not intended for use in supporting or sustaining life or of substantial importance in preventing impairment to human health, and they may not present a potential unreasonable risk of illness or injury.” – In other words, these devices are so safe, they do not require additional regulation to limit or restrict their use.
Over the past decade, Integrative Practice Solutions has helped countless medical practices nationwide successfully implement a patented non-surgical, outpatient treatment for Osteoarthritis of the Knee(s) called The Advanced Arthritis Relief Protocol™. This protocol combines many well-established FDA-approved medications, and FDA registered devices, in a unique way to generate positive clinical outcomes in excess of 92.7%, as documented in a randomized case study. Additionally, this treatment protocol is covered by most health insurance, including Medicare.
If you are a regenerative medicine provider, please do not be discouraged! This recent announcement by the FDA is not the end of your business but rather a chance to evolve and make your business stronger, more compliant, more profitable, and above all to become of better service to your patients. Quality, compassionate care, that produces positive clinical outcomes will always be in demand – this is your chance to rise to the challenge, overcome this regulatory obstacle, and come out the other side better than before! If you would like assistance in this process from an organization that has guided many before you to success under similar circumstances, please take a moment to register for a risk-free webinar that will explain all the details here. You can also reach us by phone at (855) 854-6332 or via email at firstname.lastname@example.org. We look forward to speaking, and helping you to reinvent your practice for the better!
About the Author: Lance Liberti is a nationally recognized healthcare consultant and new patient marketing professional with more than a decade of practical experience in the field. His experience spans multiple areas of practice including non-surgical spinal decompression, medically supervised weight loss, aesthetic medicine, and non-operative extremity pain management. The president and CEO of Integrative Practice Solutions, Inc. Mr. Liberti specializes in assisting health and wellness professionals to integrate boutique medical services into their practices to offer non-surgical solutions to those suffering from various degenerative musculoskeletal conditions. To learn more about Mr. Liberti’s extensive experience and see examples of his work products view his LinkedIn profile here: https://www.linkedin.com/in/lanceliberti
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