These include regenerative medicine specific clinical outcomes databases, cell counts on cellular therapies, additional safety measures, and many other items. The FDA, as well as other parties invested in the non-bio-cellular space, now mandate higher quality studies to be in place in order for a healthcare practice to offer Regenerative Medicine to their patients. In June 2021, the FDA published “Important Patient and Consumer Information About Regenerative Medicine Therapies”, which was intended to caution the public about “Stem Cell Clinics” who had been making false and fraudulent statements while performing unapproved and potentially dangerous or life-threatening procedures without sound scientific proof for safety or efficacy. With the goal of getting every patient back to optimal health and well-being, our physicians diagnose the source of pain, restore mobility, and improve the quality of life for every patient.Īlthough this emerging field of medicine had been highly unregulated for years with many unscrupulous players, the FDA recently enacted a very strict, but appropriate, regulatory framework for all Regenerative Medicine Clinics. They also help both athletes and weekend warriors recover faster after injuries, and help many adults avoid painful joint replacement surgeries and long recovery periods. The Regenerative Medicine treatments pioneered by BMG include PRP and regenerative cell injection therapy, which are innovative, minimally invasive treatment options that stimulate a natural healing response in your body with the ability to help alleviate all types of joint pain, including osteoarthritis and other degenerative conditions. As one of the original leaders in Orthopedic Regenerative Medicine, BMG continues its dedication to the development of safe and effective regenerative therapies for use in Orthopedic medicine, including Platelet-Rich-Plasma (PRP) and Cellular Therapies. We have successfully published our outcome data related to the treatment of knee osteoarthritis as well as elbow ligament injuries in throwing athletes.Īs a national leader in non-surgical orthopedic sports medicine for over a decade, you can trust that your Bluetail Medical Group physician is following all current FDA directives and is committed to furthering the ethical advancement of autologous cell treatments.Bluetail Medical Group (BMG) has been practicing Orthopedic Regenerative Medicine since 2004, in fact, before the term “Regenerative Orthopedics” was even coined! Initially offering Platelet-Rich-Plasma (PRP), BMG pioneered this field and guided treatment protocols and pathways using early clinical outcomes and anecdotal evidence at a time when very little evidence existed for this emerging field of medicine. We continue to compile outcome data on treatments we provide for numerous musculoskeletal conditions treated by Bluetail Medical Group Physicians. Our centers in Missouri, Florida, Wisconsin, Minnesota, California and Arkansas conduct clinical research and currently have an investigational new drug (IND) application filed with the FDA for the use of bone marrow concentrate in the treatment of knee osteoarthritis (IND #27390.) Bluetail Medical Group's physicians are committed to applying for and obtaining multiple future IND's for other orthopedic conditions. This statement was intended to caution the public about "Stem Cell" clinics that have been making false and fraudulent statements publicly and performing unapproved and potentially dangerous or life-threatening procedures without sound scientific proof for safety or efficacy. On June 6, 2021, the FDA published "Important Patient and Consumer Information About Regenerative Medicine Therapies".
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