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. This treatment has the potential to help patients avoid expensive and time-consuming surgery down the road. 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.Ĭellular 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. 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. BMG began regularly meeting with the FDA in 2019 when they announced the planned updates to their regulation of cellular therapies.
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.īMG has been working behind the scenes to emerge as the standard for an orthopedic regenerative medicine practice under the new FDA Regulatory Framework. 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.”īluetail Medical Group’s History with Orthobiologics and Cellular Therapyīluetail Medical has been practicing Orthopedic Regenerative Medicine since 2004, before the term “Regenerative Orthopedics” was even coined. "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. David Crane, founder and clinical director of 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. "The IDE approval is a significant milestone for Bluetail Medical Group.
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. 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. 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. Bluetail Medical Group (BMG) is pleased to announce that the U.S.
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