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. 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.
What is Regenerative Medicine?
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. 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. 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.
Regenerative Medicine and the FDA
Although 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. 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. 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. These include regenerative medicine specific clinical outcomes databases, cell counts on cellular therapies, additional safety measures, and many other items. All providers in this space must work within the updated FDA framework or they will be cited, and if they are not eventually compliant, these facilities will be closed permanently.
BMG Leading the Way in Orthopedic Regenerative Medicine
The great news is that Bluetail Medial Group has been working behind the scenes to emerge as the standard for an orthopedic regenerative medicine practice under the new FDA Regulatory Framework. BMG began regularly meeting with the FDA in 2019 when they announced the planned updates to their regulation of cellular therapies. We understood that we would not be able to successfully continue to offer our non-surgical, alternative therapeutics without collaboration with this government agency. We are excited to announce that we currently have an Investigational Device Exemption (IDE) in place with this governing agency for the use of bone marrow concentrate in the treatment of knee osteoarthritis (#27960).
The purpose of an IDE within the FDA is to encourage discovery and development of useful medical devices or treatments for human use, to the extent consistent with the protection of the public health and safety and with ethical standards, while maintaining optimum freedom for scientific investigators in their pursuit of that purpose.
Although we have been formally collecting data for over 10 years, which we have used to define our success rates with various orthopedic diseases and injuries based on sex, age, etc., we are one of just a very few practices to be operating with an IDE and look forward to enrolling patients suffering with the painful symptoms of knee osteoarthritis into our study! In the meantime, we continue to compile outcome data on treatments our physicians provide for numerous musculoskeletal conditions. We have previously published our outcome data related to the treatment of knee osteoarthritis, as well as elbow ligament injuries in throwing athletes.
Our BMG physicians will continue to grow the dynamic field of Orthopedic Regenerative Medicine in a safe and efficacious manner with guidance from the FDA. Our goals are to offer exceptional alternative and novel treatment options employing cellular and acellular products, where appropriate, to assist and treat our orthopedic patients, as well as to set the standard for clinical application of ortho-biologics in the United States.
Take The Next Step
If you would like to see if our non-surgical regenerative ortho-biologic treatments are a good treatment option for your orthopedic condition or injury, schedule a consultation today at one of our clinics throughout the U.S., including St. Louis, MO, Columbia, MO, Farmington, MO, Naples, FL, Green Bay, WI, N. Mankato, MN, and Rogers, AR. Drs. David Crane, Matt Bayes, Chris Wolf, Kristin Oliver and Luga Podesta are all national leaders in the field of orthopedic regenerative medicine, regularly speaking at industry conferences and training and consulting with other physicians in the field.
* This blog provides general information and discussion about medicine, health, and related subjects. The words and other content provided in this blog, and in any linked materials, are not intended and should not be construed as medical advice. If the reader or any other person has a medical concern, he or she should consult with an appropriately licensed physician.