The "lay of the land" for regenerative therapies, including but certainly not limited to adult stem-cell treatments, seems to change almost daily. But while there are a lot of "moving parts," it is worthwhile for practitioners who are comfortable with the fast pace, as the results of such treatments can be life-altering for thousands, if not hundreds of thousands of suffering patients.
As you read this, you may feel the regenerative therapy field is fraught with landmines, perhaps indicating that it's more trouble than it's worth; that with all these restrictions, maybe it isn't a worthwhile endeavor. That would be a mistake.
As I said, the landscape changes almost daily. We need to let due process proceed. There will come a day when treatments that have proven, consistent results will be able to be promoted as such. But it will take some time. And until then, you need to operate knowing – and adhering to – the following guidelines.
Based on recent actions the FDA has taken, here are a few areas to monitor / manage as you get involved in the regenerative medicine field.
1. Treatment of Diseases
You should not recommend regenerative therapies for the treatment of diseases until such time as the FDA has endorsed their use for doing so. Only clinics that are part of approved research studies can offer this type of treatment; if you are not one, it puts the entire medical staff at risk for sanctions against their licenses.
Defending these types of issues is extremely expensive and time consuming. So, in this instance, the end certainly does not justify the means. Yes, it makes for an obstacle, but one I hope will be overcome in time with objective findings and published papers..
2. Any Promise or Implied Guarantee of a Positive Result
It is vital that patients are informed that there is no guarantee of a result. You just can't do it, period. It is imperative to make that known immediately, during the initial patient consultation.
3. Pricing
Do some research on not only what others across the country are charging, but also whether any parameters have been set in your local area. You need to justify your fees. Consider a discount to patients if they desire multiple treatments.
4. Advertising
Many experts feel it is critical you offer as wide a range of options to patients as possible. Such options would include PRP, amniotic, chorionic and adult stem cells in your clinic. This means you should engage with companies that offer FDA-approved systems for adult stem-cell treatments.
If you do not offer both adult and placenta-derived options, it is vital that all advertising reflects that fact. And as already mentioned, do not make any claim of curing disease – or any guarantees, period.
5. SVF: Adipose-Derived Stem Cells
The FDA has taken an exception to any procedure that utilizes enzymes to separate the stem cells from adipose tissue. Two clinics have already been charged for treating disease with SVF (Stromal Vascular Fraction). Until the FDA position changes, you should ensure that any adipose system and treatments you perform are FDA compliant.
6. Mode of Administration
It's a wise idea for any placenta-derived product to be administered into joints only. Otherwise, you are playing with fire. Any other mode of administration is risky.
7. Scope of Practice
Any regenerative procedure performed in your office must be within the scope of the medical provider in that state. It is up to each clinic to do its own due diligence to ensure it is compliant.
If you are using a physician extender, ensure that all procedures they perform in your office are within their scope. It would be best to obtain a written statement to that fact from their state board.
To my knowledge, there are no states in which a chiropractor or any non-licensed medical professional can perform these services at this time.
Do It by the Book
I realize some of you may find this article somewhat daunting. But we need to really be "button downed" with regenerative medicine and "do it by the book," as any deviation outside current FDA rules is dangerous.
One of the most important points and lessons I have learned in this field is not to trust any statements of fact from company sales representatives unless they will put it in writing on company letterhead. Our medical team has interviewed more than 40 different companies and each one has told us it has the best product for various reasons. Whatever products you currently use or decide to use, make sure what you're told is the truth and doesn't put you or your patients in jeopardy.
That said, don't let any of these guidelines stop you from offering the tremendous benefits of regenerative therapies. Right now, it's a little frenetic, but just stay updated to the moving parts and react accordingly. These therapies can offer results like we've never seen in health care, and they are well-worth the time, energy and financial investment to practitioners who are "wired" to thrive with them as a practice service.
Dr. Brent Detelich, former president of the Stem Cell Institute of America (www.americastem.com), is a 1993 graduate of Parker College and a second-generation chiropractor. During the past five years, he and his medical team helped to train more than 300 practices on medical integration for the purpose of offering safe, effective and compliant regenerative therapies.