Two Considerations Before Administering Stem Cell and Exosome Therapies in Your Practice

Our healthcare law firm works with many providers and healthcare practices to assist them in complying with federal, state, and local laws. In particular, our med spa clients often ask to consider whether they can offer stem cell or exosome therapies as part of their practice. Stem cell and exosome therapies are popular treatment items for med spas, but offering these therapies also carries legal risk and compliance issues. This blog covers two considerations that med spas should consider before offering stem cell and exosome treatments to patients for therapeutic purposes. If you need assistance setting up a med spa to offer stem cell and exosome treatments or would like to discuss this blog post, you may contact our healthcare law firm at (404) 685-1662 (Atlanta) or (706) 722-7886 (Augusta), or by email, info@littlehealthlaw.com. You may also learn more about our law firm by visiting www.littlehealthlaw.com.

Background

Stem cells and exosomes are biological products that can be marketed and sold only if a business has a valid biologics license application (BLA) or, if in the development stage, such a product can be distributed for clinical use in humans if the sponsor has an Investigation New Drug (IND) designation. If a sponsor has an IND and wishes to work with another entity to investigate by conducting research, that researching entity must submit an FDA Form 1571, which informs the FDA of the sponsor-investigation relationship.

Stem cell research has come up recently in finding ways to treat certain diseases such as cancer, but the FDA treats the use of stem cells for treating certain diseases differently from the use of stem cells for regenerative treatments, as is what stem cells are commonly used in the med-spa space.

First Consideration: The FDA Has Issued Warning Letters to Manufacturers and Consumer Alerts About Regenerative Medicine Products that Include Stem Cells and Exosomes

The FDA is aware of the risks of regenerative medicine products and have issued warning letters to manufacturers and sellers that market stem cell and exosome products. Additionally, the FDA has warned consumers that some regenerative medicine products are illegally marketed and have misleading claims about their efficacy. The FDA has also received reports of adverse events from unapproved products containing stem cells and exosomes, including blindness, infections, and tumor formation. Products containing stem cells or exosomes are classified as “new drugs” and are required to go through the FDA approval process, and offering unapproved or misbranded drugs carries risk, including adverse reactions, board complaints, and lack of insurance coverage.

Second Consideration: Mid-Level Providers Should Consider Whether Offering Stem Cell or Exosome Products Falls Within Their Scope of Practice

Because products containing stem cells or exosomes would be classified as drugs, providers at med spas need to follow state scope of practice laws before prescribing these treatments. In Georgia, for example, this requires a good-faith exam by a physician, physician assistant with a job description with a supervising physician, or a nurse practitioner with a nurse protocol agreement with a delegating physician, where the provider prescribes stem cell or exosome treatment based on the patient’s history or physical.

If your med spa uses registered nurses (RNs) or medical assistants, scope of practice laws for registered nurses also need to be followed to administer stem cell or exosome therapies. In Georgia, if a registered nurse or medical assistant issues the stem cell or exosome treatment, the registered nurse can administer the prescribed treatment only after the individualized prescription for the prescribed treatment is issued, and the RN has the sufficient knowledge, skill, and competency necessary to administer the treatment safely. Although subcutaneous and intramuscular injections may be delegated to medical assistants, a physician, physician assistant, or nurse practitioner must be on site while the medical assistant is performing the services. RNs also cannot delegate or otherwise allow unlicensed personnel, such as medical assistants, to perform services that require nursing licensure unless there is explicit statutory authority to do so.

If you need assistance setting up a med spa that offers stem cell or exosome therapies, have questions about whether your practice is compliant with the various laws and regulations surrounding stem cells and exosomes, or would like to discuss this blog post, you may contact our healthcare law firm at (404) 685-1662 (Atlanta) or (706) 722-7886 (Augusta), or by email, info@littlehealthlaw.com. You may also learn more about our law firm by visiting www.littlehealthlaw.com.

 

 

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