FDA Compliance treating knee arthritis

NON-SURGICAL KNEE ARTHRITIS TREATMENTS CAN GET YOU ACTIVE AGAIN WITHOUT SURGERY!

 

The doctors at Southcoast believe regenerative therapy is the future of medicine.  Patients who previously would have had surgery, are now finding relief without going under the knife, with less recovery time, less major risks, and no hospitalization.  The promise of Regenerative Medicine and stem cell therapy is incredible. 

 

In 2017 the FDA commented that they decided to regulate cell therapy more aggressively. Their concerns were that there were “bad actors” in this field who were offering products that could be dangerous and may have little potential for benefit.  Many healthcare groups offering regenerative treatments were making incredible promises and even offering treatments to cure COPD and vision issues, with more than one patient sustaining further injury.

How does a patient know whom to believe?

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 had 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.

Southcoast Medical, is an affiliate of the Bluetail Medical Group, and our centers in Missouri, Naples Florida, Wisconsin, Minnesota, and Arkansas 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.) We are committed to applying for and obtaining multiple future IND’s for other orthopedic conditions. We continue to compile outcome data on treatments for numerous musculoskeletal conditions. We have successfully published our outcome data related to the treatment of knee osteoarthritis as well as elbow ligament injuries in throwing athletes.

We started Southcoast Medical to give patients non-surgical options that really work. Many of these are not covered by insurance, but we hope one day that will change. Evidence mounts monthly that these procedures can be effective. It is our goal to offer patients procedures that have a good chance of success and that we, were we the patient, would choose to do ourselves.

When you are trying to choose your best option for regenerative treatments, consider this:

• Choose a Medical Group with board certified physicians, not one run by ancillary providers
• Expect to be seen and evaluated by a doctor
• Expect your provider to understand your issues, be familiar with interpreting your studies, and able to offer you options
• Consider a group that is currently following all current FDA directives and is committed to furthering the ethical advancement of autologous cell treatments

We believe regenerative medicine works, and our goal is to give you your best option for success. Often this is with regenerative treatments, but not always. If that is the case, we will explain why and direct you to those who can help.

At Southcoast, we are striving to give you the best options available, those we would choose were we in your position.

Come see us!