On June 6, 2021, the FDA published "Important Patient and Consumer Information About Regenerative Medicine Therapies". This statement was intended to caution the public about "Stem Cell" clinics that have been making false and fraudulent statements publicly and performing unapproved and potentially dangerous or life-threatening procedures without sound scientific proof for safety or efficacy.
Our FDA Compliance
Our centers in Missouri, Florida, Wisconsin, Minnesota, California, Indiana, and Connecticut conduct clinical research and currently have an investigational new drug (IND) application filed with the FDA for the use of bone marrow concentrate in the treatment of knee osteoarthritis (IND #27390).
Bluetail Medical Group is committed to full compliance with all FDA regulations regarding regenerative medicine therapies. We believe that patient safety is paramount and that all regenerative treatments should be backed by sound scientific evidence.
What This Means for Our Patients
As a patient at Bluetail Medical Group, you can be confident that:
- All of our regenerative medicine procedures comply with current FDA regulations
- Our bone marrow concentrate treatments are conducted under an active IND application
- We use only FDA-compliant biologics and devices in our treatments
- Our physicians are trained in the proper use of regenerative therapies according to federal guidelines
- We do not make unsubstantiated claims about the efficacy of our treatments
Our Commitment to Evidence-Based Medicine
Bluetail Medical Group is dedicated to advancing the field of regenerative medicine through rigorous clinical research. We participate in clinical trials and contribute to the body of scientific knowledge that supports the safe and effective use of regenerative therapies.
We encourage patients to be cautious of clinics that make extraordinary claims about stem cell treatments or that are not transparent about their FDA compliance status. If you have questions about our regulatory compliance or the safety of our procedures, please don't hesitate to contact us.