02/27/2019
FDA Labels our Amnion Injections as “Regenerative Medicine Advanced Therapy”:
In March, the U.S. Food and Drug Administration awarded a treatment in use at Primary Spine & Rehab the “Regenerative Medicine Advanced Therapy” designation (RMAT). This is only the 15th time the FDA has awarded this designation since its creation. The treatment in question is trademarked AmnioFix®. We sometimes generically refer to this treatment as amnion injection. With this designation, the FDA is specifically recognizing AmnioFix’s potential role in the treatment of knee arthritis, which is one of its many uses.
Knee Osteoarthritis Approaching Endemic Levels
Amnion injections have been shown to improve even the most treatment-resistant tendon and ligament disorders with only one shot. The FDA is specifically looking at AmnioFix’s potential role in knee osteoarthritis (KOA), which is a different kind of pain complaint. While many people may consider knee arthritis just another nagging pain, KOA actually causes more disability in walking than any other disease. By some measures, 40% of people age 56-64 have it. With an aging population, increasing levels of obesity, and increasing levels of inactive lifestyles, some estimates have knee arthritis reaching endemic levels in the coming decades. “Endemic” is a description of a serious disease that has become too common. Endemic is like an epidemic – the difference being that an epidemic is unpredictable.
Preventing Osteoarthritis Disability
The healthcare profession has major untapped potential for helping patients with knee arthritis. Osteoarthritis of the knee often starts in a person’s 40s or earlier and progresses for a decade or more before becoming disabling for some. In the past, medical professionals have largely waited until joint failure to do anything other than cover the pain. However, regenerative medicine treatments delivered with exercise therapy and other physical therapy approaches have strong potential to slow the knee’s degeneration, preventing disability in future decades.
Federal Government Encourages Greater Use of Regenerative Medicine
The U.S. Congress created the RMAT to encourage advancement in the field of regenerative medicine. To be eligible, a treatment must have clinical evidence demonstrating it can provide solutions for serious conditions, especially conditions that are sometimes difficult to treat. Regenerative medicine refers to treatments that focus a patient’s own healing responses exactly where they are needed to accelerate healing or rebuild non-healing tissues. The FDA states, “Regenerative medicine is a rapidly expanding field that has the potential to treat serious conditions, particularly in patients with unmet medical needs.” In a setting such as Primary Spine & Rehab, a multi-specialty musculoskeletal pain relief center, AmnioFix can help in the treatment of conditions such as arthritis pain, back pain, tennis elbow, ACL strain, post-surgical ACL recovery, tendon tears, fasciitis, etc.
What is AmnioFix®?
AmnioFix is a product of dehydrated membrane suspended in an injectable solution. It promotes tissue healing better than any synthetic drug. The membrane used in the product is human amnion, the innermost layer of the placenta. AmnioFix contains 226 different growth factors. In addition to providing building blocks for tissue repair, the injection influences a patient’s own body to direct more of its healing response to the targeted area. Clinicians use ultrasound-guided injections to deliver the treatment to very targeted areas specific to each patient’s individual condition.
To learn more about regenerative medicine, visit the website of Primary Spine & Rehab or call 860.763.2225 to schedule an appointment.
More: https://enfieldhealth.nwsltr.info/2019/02/fda-labels-our-amnion-injections-as-regenerative-medicine-advanced-therapy/