FDA Regulations on Regenerative Medicine (IDE#27960)
The Albano Clinic has been practicing Orthopedic Regenerative Medicine since 2007. In fact, the term “Regenerative Orthopedics” had not even been coined when he started. He initially guided our treatment protocols and pathways using early clinical outcomes data and anecdotal evidence. A new field of medicine cannot use an evidence-based approach when no evidence yet exists!
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 interested and heavily invested parties 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, and if not eventually compliant, closed permanently.
The great news is that The Albano Clinic in conjunction with CRRI has been working behind the scenes to emerge as the standard for an Orthopedic Regenerative Medicine practice under the new FDA Regulatory Framework. The Albano Clinic with CRRI began regular meetings with the FDA over 2 years ago 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 our alternative therapeutics. 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.
Dr. Joseph Albano at The Albano Clinic will continue to grow the dynamic field of Orthopedic Regenerative Medicine in a safe and efficacious manner with guidance from the FDA. His 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 ortho-biologics in the United States.
Stop giving restrictive injuries and debilitating pain control over your life.
With a little help from Dr. Joseph Albano and targeted orthopedic cellular treatments, you have the power to heal, feel stronger than before and return to the life you love.
Find out if Regenerative Orthopedics and Cell Therapy are right for you.