Changes Are On the Horizon for Regenerative Medicine Treatments

There are many clinics around town that may be closing down in the next few months. This is not because stem cell treatments are ineffective but because the FDA is officially (finally) cracking down on stem cell clinics that offer treatments using solely birth products. Birth products are products that you can purchase, and are not stem cells from your own body. This consists of things like amniotic fluid, umbilical cells, exosomes, and more. While some of these products do work to decrease pain and improve function, there are many companies selling these products which have not been thoroughly vetted or researched.

This is actually great news for patients and for the medical community. About 7 years ago, vendors began selling birth products to physicians, and anyone with a credit card willing to purchase them. While there are very good reasons to sometimes use someone else’s stem cells, the distribution of stem cell products to anyone with a credit card became widespread and problematic. Once stem cell products could be purchased, anyone claiming they were trained in stem cells had access to these procedures. What happened was that these cellular products became a hot commodity, more than the actual practice of safe medicine, thereby decreasing the validity of the procedures.

When physicians go through very rigorous training, you can be sure that they have done a certain amount of procedures and injections prior to ever being allowed to practice medicine. The same holds true for physicians practicing in the Regenerative Medicine space. In order to offer stem cell procedures to patients, physicians had to undergo rigorous training, both on cadavers, and on volunteers, to learn how to:

1. Extract stem cells from patients
2. Appropriately and delicately process the stem cells
3. Inject the stem cells under imaging guidance (ultrasound or fluoroscopy)
4. Determine when to perform stem cell procedures
5. Evaluate risks and complications from these procedures
6. Handle an emergency or adverse outcome
7. Know when NOT to perform these procedures.

Without this established standard of training, it is impossible to have even a small baseline understanding as to what may have caused a bad outcome in a patient. Typically when a patient has an adverse outcome from a procedure, we don’t have to evaluate the credentials of “who” did the procedure, as we understand that their basic training has been standardized and complete.

Now that anyone with a needle can offer these procedures to patients, the procedure as a whole has lost credibility, and it has become increasingly unsafe for patients. Never before in medicine did we have to consider if someone was appropriately trained to even do the procedure. Was it poor training? Was it no training? Did the provider do ultrasound or fluoroscopically guided procedures? How many injections had they performed prior to doing stem cells. (for comparison, I had performed thousands of joint injections prior to even becoming proficient in regenerative medicine). You wouldn’t get a total knee replacement by someone who had just bought surgical supplies and watched a youtube video. So why are we doing this with regenerative medicine?

Without having a system to know exactly what a company is selling, we cannot guarantee sterility and even that what is in the product is what the company claims is in the product. This is deceitful and extremely dangerous to both the patient and the physician performing the procedure. Additionally, the companies selling these products have made outrageous claims as to what stem cells can actually treat, without proven studies. This has been giving some patients high hopes of improvement in their condition, without real results. The providers that have been selling these stem cells to patients and making false claims will also be taken down with the stem cell companies.

Where does that leave us in terms of stem cell procedures? It will begin to leave us with physicians who have been well trained in the pros and cons of these procedures. It will eventually get rid of “bad actors” both in terms of companies selling products and in terms of providers attempting to make money off unsuspecting patients. While I don’t always agree with what the FDA does and does not approve, I think this is a great move in the right direction for Regenerative Medicine.

If you are wondering when you would consider a Regenerative Medicine procedure, please read the next blog, as I will be discussing the benefits of Regenerative Medicine and when to consider these procedures for yourself.