Heeding "Stem Cell Clinic" Red Flags

As the health benefits of regenerative medicine and stem cell therapy become more widely discussed in the public setting, we expert medical providers find that people talking about this burgeoning field of medicine isn’t the same as people understanding it. Unfortunately, there are some ‘stem cell clinics’ in the U.S. and abroad that have attempted to capitalize on this public misunderstanding by marketing and misusing stem cell therapy to treat conditions it is not intended to – from macular degeneration and ALS to Parkinson’s Disease and Multiple Sclerosis – resulting in some devastating health consequences for victims and fear and skepticism from the public. So how is someone who is suffering from a painful and debilitating disease supposed to know which stem cell treatments and providers are legitimate options and which are dangerous? We can help.

In November 2017 the U.S. Food and Drug Administration (FDA) released a comprehensive warning including regulatory considerations and guidelines for the use of human cells, tissues and cellular and tissue-based products.  In a nutshell, these guidelines were released in an attempt to increase patient safety surrounding the use of stem cell and regenerative medicine treatments. This was also a direct warning to those bad actor clinics claiming the ‘cure-all’ ability to take a patient’s fat, breaking it down for its stem cells, and then put them back into the body. Whether the fat-derived stem cells were used in a joint for arthritis or placed intravenously to help with chronic conditions like COPD, Parkinson’s Disease, or Multiple Sclerosis – these practices are both unapproved by the FDA and unproven scientifically.

So what are the “red flags” a patient should heed the warning of when considering stem cell therapy as a treatment option for what ails them? Here are some tips:

1.) Unqualified Providers – Experience and appropriate training are critical in any medical field and regenerative medicine and stem cell therapy are no exceptions. You should have more confidence in physician providers who are board-certified and have additional training to provide stem cell injections. For example, Bluetail Medical Group physicians have a combined 54 years of experience in the regenerative medicine field.

2.) Unapproved Use – If you come across a clinic that is advertising IV stem cell treatments, beware! This practice is strictly forbidden by the FDA and is truly outside the scope of care intended for stem cell therapy.

3.) Ignoring FDA Directives – Truth be told, the FDA does not approve or disapprove any procedure, including stem cell therapy. Therefore, any clinic that markets its services as ‘FDA approved’ is being untruthful. That being said, there are clinics, like Bluetail Medical Group, whose processes and devices are in compliance with FDA directives. These include how stem cells are treated after they are harvested and the components of what is injected. Our clinic also utilizes the Arthrex angel centrifuge that is FDA-approved for this use.

4.) A Cure-All for All – There is no stem cell clinic in the world that will be able to help every patient who walks through its doors – including Bluetail Medical Group. We do not treat every patient we see. After consultation and analysis of the problem, if we aren’t confident we can help, we will be open, honest and up-front about that. In addition, even if we believe we can help, we will also be truthful with patients about their specific chance for success given their condition. This success percentage depends on many factors and as with any medical procedure, stem cell or otherwise, results can never be guaranteed. Beware the clinic that attempts to provide 100% assurance it can cure your (fill in the blank). Providing false hope is unethical and something medical providers are called to entirely avoid.

Here is the key message we hope you take away from this blog if you are considering treatment at a clinic making claims that just don’t sit quite right with you, ask questions. Does the provider seem knowledgeable about the treatments he or she is suggesting? Does he or she cite research or scientific data to back up the treatment that is being suggested? Does he or she assume a defensive posture toward your questions? If the overwhelming answer to these questions is no, then go with your gut and leave.

While the physicians of Bluetail Medical Group wholeheartedly believe that regenerative and stem cell therapy has the potential to heal injuries by growing new healthy tissue with the potential to fully repair damaged tissue, decrease pain, improve function, diminish progression of injury, and improve daily life. We also recognize the imperative need to educate our patients and the public about the scientific facts and truthful statements about stem-cell therapy. Being a ‘trusted medical provider’ is something we are extremely proud of. After all, the oath of all physicians is to ‘first do no harm.’