FDA Regulations &
Clinical Compliance
Committed to practicing regenerative medicine within current FDA guidelines while helping advance the field through responsible research, safety standards, and evidence-based care.
Why FDA Regulations Matter
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.
Our Commitment to Compliance
Clinical Outcomes Tracking
We maintain rigorous Regenerative Medicine-specific clinical outcomes databases, tracking patient progress and results to meet FDA requirements and improve care quality.
Safety Standards
Cell counts on all cellular therapies, full informed consent protocols, and additional safety measures are core to every procedure we perform.
Research Participation
Through our partnership with CRRI, The Albano Clinic actively participates in research that helps establish evidence-based standards for the entire regenerative medicine field.
Evidence-Based Care
We operate within the updated FDA regulatory framework — using data, outcomes tracking, and published research to guide every treatment protocol.
FDA Certified
IDE #27960
FDA Investigational Device Exemption (IDE #27960)
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 two years ago when the agency announced updates to its regulation of cellular therapies.
Through many hours of consultation with the FDA, we 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.
Building the Future of Regenerative Medicine Responsibly
Rather than waiting for regulators to come to them, The Albano Clinic chose to engage the FDA directly — initiating ongoing consultations and participating actively in the process of shaping responsible standards for regenerative medicine.
Through its partnership with CRRI (Center for Regenerative Research and Innovation), the clinic began formal meetings with the FDA when the agency first announced its updated framework for cellular therapies. This proactive stance positioned The Albano Clinic as a collaborative partner in the regulatory process rather than a passive recipient of mandates.
That work led to the successful procurement of FDA IDE #27960 — a meaningful milestone representing the clinic's commitment not just to compliance, but to advancing the entire field. The goal is not merely to satisfy current requirements, but to help set higher standards that benefit patients and practitioners across the country.
Every patient treated at The Albano Clinic benefits from this commitment — because a practice that holds itself to the highest standard of evidence, safety, and transparency is a practice where patients can trust their care.
"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.
Questions About Regenerative Medicine?
We believe patients deserve transparent information about treatment options, safety standards, and current FDA regulations.