Bluetail Medical Group (BMG) is pleased to announce that the U.S. Food and Drug Administration (FDA) has approved the company's Investigational Device Exemption (IDE) application, permitting BMG to begin a feasibility study of cellular therapy in the treatment of knee osteoarthritis (OA) in the U.S. Cellular therapy is intended for candidates who have been diagnosed with moderate osteoarthritis of the knee and whose conditions are not severe enough to require surgery. The pivotal study will evaluate the safety, protocol, and results of cellular therapy using adult mesenchymal regenerative cells from bone marrow in the patient’s hip in the treatment of moderate-stage knee osteoarthritis.
"The IDE approval is a significant milestone for Bluetail Medical Group. Now with an IDE in hand, we aim to enter the last phase of demonstrating the clinical potential of the use of cellular therapy in the treatment of knee osteoarthritis, with the ultimate goal of obtaining insurance reimbursement for our patients’ ortho-biologic treatments, said Dr. David Crane, founder and clinical director of Bluetail Medical Group. "We are on one of the first groups in the country to have the go-ahead to start FDA trials in this exciting medical field. We are currently gearing up to initiate a study that will take place at three of our clinical sites to enroll up to 120 patients presenting with moderate-stage knee osteoarthritis.”
Bluetail Medical Group’s History with Orthobiologics and Cellular Therapy
Bluetail Medical has been practicing Orthopedic Regenerative Medicine since 2004, before the term “Regenerative Orthopedics” was even coined. Initially offering Platelet-Rich-Plasma (PRP), BMG pioneered this field and guided the 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.
BMG 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. The partner physicians, Drs. David Crane, Kristin Oliver, Matt Bayes, Luga Podesta, and Chris Wolf, understood that they would not be able to successfully continue to offer our non-surgical, alternative therapeutics without collaboration with this government agency. As one of the original leaders in orthopedic regenerative medicine, our physicians continue their dedication to the development of safe and effective regenerative therapies for use in orthopedic medicine, including Platelet-Rich-Plasma (PRP) and cellular therapies.
Orthobiologics and the FDA
Cellular Therapy in the field of orthobiologics is an innovative, minimally invasive treatment option that stimulates a natural healing response in the body that has the ability to help alleviate joint pain, including osteoarthritis and other degenerative conditions. This treatment has the potential to help patients avoid expensive and time-consuming surgery down the road. 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 of 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, stricter safety measures, and collection of many additional data points. All providers in this space must work within the updated FDA framework or they will be cited or closed for non-compliance.
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.