Is stem cell therapy FDA approved? This is one of the most frequent questions presented by our patients. This is an issue we have to address several times a week. I usually answer that question by asking patients if they have received other treatments, such as epidural injections, joint injections with corticosteroids, ACL repair surgeries, rotator cuff surgeries, etc., and point out that none of those treatments are “FDA approved”. Patients are usually surprised by that. I then proceed to explain them that the FDA does not approve medical treatments, or what is considered the practice of medicine.
There seems to be quite a bit of confusion and misinformation about what the FDA regulates and what does it mean to be “FDA Approved”. The FDA approves the use of medicines. Any new medicine, before it can used in the USA, needs to go through the FDA regulatory process, a process that includes several research studies in both animals and humans. The medicine has to, first, be shown to be safe for use in humans, and second, it has to be shown to be more effective than placebo for a specific medical condition or diagnosis. Once the new drug has shown that, it can then receive an approval from the FDA which is specific for the diagnosis or condition studied by the pharmaceutical company. However, after the drug is approved, physicians have the option to use, if they deem necessary, that drug for conditions other than the one specifically approved by the FDA. This is what is called “off-label” use. Off-label prescription of medicines by physicians is not restricted by the FDA, as this is considered to be within the realm of the normal practice of medicine. The FDA, again, does not approve, or regulate medical treatments or the practice of medicine. This is done at the state level through State Medical Boards.
The FDA has also received the responsibility to regulate medical devices. In order for any medical device to be used in the USA, it has to be cleared by the FDA. However, the process for approval of new medical devices is very different (and simpler) than the process to approve new medications. Medical device manufacturers do not need to show that their new devices are effective in the treatment of any medical condition. They only need to show that they are safe for use in patients. Therefore, when a medical device says that it is “FDA approved” that only means that the FDA thinks the device is safe, not that the FDA has confirmed that the device is useful in any way.
Some confusion has been created in the stem cell therapy industry by the curious claim by the FDA that stem cells (or any other human tissue) become a drug if they undergo more than “minimal manipulation.” If those cells are now a ‘drug”, then, they can, and they will be regulated by the FDA. The exact meaning of “minimal manipulation” is not known as the FDA has not clarified the phrase’s meaning. The FDA, however, has already established than growing stem cell in a lab before re-injecting them constitute more than “minimal manipulation”, even if the cells are injected into the same donor. Therefore, the use of cultured, or expanded, stem cells is banned in the USA unless you are willing to spend a hundred million dollars or more in trying to get them approved by the FDA as a new “drug”. Some clinics in the USA are offering treatment using stem cells cultured and grown in a lab. Those labs have been set up in foreign countries, and patients have to fly there (and pay exorbitant prices) to receive that treatment. However, stem cells therapies that use cells harvested from the same patient (autologous) and injected the same day, as part of the same procedure, is considered part of the practice of medicine, and allowed in the USA. This is the type of stem cell therapy we offer at our clinic.
One form of stem cell therapy that seems to have been targeted by the FDA as not meeting the requirements of “minimal manipulation’ is what is called SVF (Stromal Vascular Fraction) which is a method of digesting with enzymes the fat to eliminate some of the solid components of the fat, leaving the stem cells for injecting the affected body part. There are many stem cell clinic in the USA currently using SVF fat procedures, including all clinics advertising intravenous (IV) therapies using stem cells. However, it seems clear, from recent FDA position statements that these procedures may be considered illegal by the FDA. Because of the uncertainties of the FDA position regarding SVF, we at Regenerative Orthopedic Institute are not using, and have never used SVF fat procedures. This may change in the future, if and when the FDA clarifies what “minimal manipulation” really means, and if the cloud of uncertainty regarding SVF is lifted. Besides, no one has been able to show, so far, that SVF is a better than bone marrow aspirate or undigested fat for orthopedic treatments.
So, even though our stem cell treatments are not “FDA Approved”, because the FDA does not approve any medical treatments, all of our stem cell treatments are in complete compliance with current FDA regulations, and current interpretations of those regulations.
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