FDA Regulatory Policy Regarding Regenerative Medicine
ORIGEN (formerly Rejuv Medical Southwest) has been utilizing Regenerative Orthopedic treatments since 2013. In fact, the term “Regenerative Orthopedics” had not even been coined when we began utilizing prolotherapy and Platelet Rich Plasma (PRP) treatments.
We initially guided our treatment protocols and pathways using early clinical outcomes data and anecdotal evidence. An evolving field of medicine cannot use an evidence-based approach when there was not adequate evidence yet in the literature.
As we expanded our cellular treatment offerings it became imperative to collect outcomes data to ensure safety and efficacy. We began using a data collection system that was engineered for Orthopedic Surgeons since one did not exist at that time for Orthopedic Regenerative Medicine.
Within our affiliate network (Bluetail Medical Group) we have been collecting outcomes data for more than 10 years. We use this data to define our success rates with various orthopedic diseases and injuries.
As of June 2021, the FDA has put into place a very strict but appropriate regulatory framework for all Regenerative Medicine Clinics. The regulators within the FDA, as well as other parties invested in the non-bio-cellular space, are mandating higher-quality studies to be in place to practice Regenerative Medicine.
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. If not eventually compliant, these facilities will be closed permanently.
The great news is that ORIGEN, in conjunction with Bluetail Medical Group (BMG) and the Cellular Regenerative Research Initiative (CRRI), have been working behind the scenes to emerge as the standard for an Orthopedic Regenerative Medicine practice under the new FDA Regulatory Framework.
BMG, with CRRI, began regular meetings with the FDA in 2019 when the latter announced the planned updates to their regulation of cellular therapies.
We understood that without collaboration with this government agency we would not be able to successfully continue to offer these alternative therapeutic treatments. Through many hours of consultation with the FDA we have secured an IDE (#27960) with the FDA for the use of Bone Marrow in Knee Osteoarthritis. We are using this initial IDE to build upon for other orthopedic diseases.
The doctors at ORIGEN and BMG are committed to growing 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 patients and to set the standard for clinical application of orthobiologics in the United States.