Dynamic Stem Cell Therapy

The United States Food and Drug Administration (FDA) reviewed your company’s website at https://stemcellpowernow.com (last visited February 2026), through which your company markets an umbilical cord-derived stem cell product for allogeneic use (hereinafter, “your umbilical-cord derived product”).

This letter is to advise you that your misbranding of your umbilical-cord derived product while held for sale after shipment in interstate commerce violates section 301(k) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. § 331(k).

Based on information and records reviewed by FDA, https://stemcellpowernow.com (last visited February 2026), your umbilical-cord derived product is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease or conditions in humans and/or is intended to affect the structure or function of the body. For example, you make the following claims about stem cells (which you state are used to make your umbilical-cord derived product):

Under a title of Regenerative Medicine for Sports Injuries, “There are a number of different types of sports injuries that can be treated with stem cells, including:o Knee injuries such as ligament tears and cartilage damageo Shoulder injuries such as rotator cuff tears and bursitiso Ankle and foot injuries such as ankle sprains and Achilles tendon ruptureso Hip injuries such as hip labral tears and arthritiso Muscle strains and tears”

Under a title of Anti-Aging Stem Cell Therapy, “Anti-aging isn't the only amazing thing stem cell therapy can do--it has also been shown to improve various conditions resulting from injuries, like knee pain, spinal cord injury, joint pain, cardiovascular disease, and arthritis.”

Therefore, your umbilical-cord derived product is a drug as defined in section 201(g)(1) of the FD&C Act, 21 U.S.C. § 321(g)(1), and a biological product as defined in section 351(i) of the Public Health Service Act (PHS Act), 42 U.S.C. § 262(i).

Your umbilical-cord derived product is also a human cell, tissue, or cellular or tissue-based product (HCT/P) as defined in 21 CFR 1271.3(d) and is subject to regulation under 21 CFR part 1271, issued under the authority of section 361 of the PHS Act, 42 U.S.C. § 264. HCT/Ps that do not meet all the criteria in 21 CFR 1271.10(a) are not regulated solely under section 361 of the PHS Act and the regulations in 21 CFR part 1271. Unless an exception in 21 CFR 1271.15 applies, such products are regulated as drugs, devices, and/or biological products under the FD&C Act and/or the PHS Act and are subject to additional regulation, including applicable premarket review. Based on a review of relevant materials, Dynamic Stem Cell Therapy does not qualify for any exception in 21 CFR 1271.15, and your umbilical-cord derived product fails to meet all criteria in 21 CFR 1271.10(a).

For example, your umbilical-cord derived product fails to meet the minimal manipulation criterion set forth in 21 CFR 1271.10(a)(1) and defined for structural tissue in 21 CFR 1271.3(f)(1), because your processing alters the original relevant characteristics of the umbilical cord related to its utility for reconstruction, repair, or replacement. The processing of the umbilical cord from the form of a conduit into an injectable form, significantly alters the physical state of the HCT/P. The umbilical cord is more than minimally manipulated because such processing alters the original relevant characteristics of the HCT/P relating to its utility to serve as a conduit by effectively altering or eliminating its physical integrity and tubular form.

In addition, your umbilical-cord derived product fails to meet the criterion that the HCT/Ps be “intended for homologous use only.” Homologous use means that the “labeling, advertising, or other indications of the manufacturer’s objective intent” demonstrate that the HCT/P is intended to perform “the same basic function or functions in the recipient as in the donor” (21 CFR 1271.3(c) and 1271.10(a)(2)). Your umbilical-cord derived product is not intended solely to perform the same basic function or functions of the HCT/P in the recipient as in the donor (e.g., serving as a conduit). Rather, your umbilical-cord derived product is intended for use in the treatment of cardiovascular disease or arthritis, for example, which is not a basic function of the human umbilical cord in the donor.

Therefore, this HCT/P is not regulated solely under section 361 of the PHS Act, 42 U.S.C. § 264, and the regulations in 21 CFR part 1271.1 See 21 CFR 1271.20. In addition to being regulated under section 361 of the PHS Act and 21 CFR part 1271, your umbilical-cord derived product is regulated as a drug as defined in section 201(g)(1) of the FD&C Act, 21 U.S.C. § 321(g)(1), and a biological product as defined in section 351(i) of the PHS Act, 42 U.S.C. § 262(i), as stated above.

Your umbilical-cord derived product is a misbranded drug under section 502(f)(1) of the FD&C Act, 21 U.S.C. § 352(f)(1). A drug is misbranded under section 502(f)(1) if the drug fails to bear adequate directions for its intended use(s). “Adequate directions for use” means directions under which a layperson can use a drug safely and for the purposes for which it is intended. 21 CFR 201.5. Prescription drugs, as defined in section 503(b)(1)(A) of the FD&C Act, 21 U.S.C. § 353(b)(1)(A), can only be used safely at the direction, and under the supervision, of a licensed practitioner.

Your umbilical-cord derived product is intended for use in the treatment of one or more diseases that are not amenable to self-diagnosis or treatment without the supervision of a licensed practitioner. Therefore, it is impossible to write adequate directions for a layperson to use your umbilical-cord derived product safely for its intended purposes. Accordingly, your umbilical-cord derived product fails to bear adequate directions for its intended uses and, therefore, is misbranded under section 502(f)(1) of the FD&C Act, 21 U.S.C. § 352(f)(1). Misbranding your umbilical-cord derived product while it is held for sale after shipment of the drug or one or more of its components in interstate commerce is prohibited under section 301(k) of the FD&C Act, 21 U.S.C. § 331(k).

Your umbilical-cord derived product is not the subject of an approved biologics license application (BLA) under section 351(a)(1) of the PHS Act, 42 U.S.C. § 262(a)(1). Such licenses are issued only after showing that the product is safe, pure, and potent. If your umbilical-cord derived product was the subject of an approved BLA and labeled consistent with the approval, it would bear adequate directions for its intended uses, and subject to exceptions not applicable here, it could be lawfully introduced or delivered for introduction into interstate commerce.

In addition to the violations described above, we offer the following comment:

FDA’s review of your website also found that you market exosomes. As a general matter, exosomes intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease or conditions in humans and/or are intended to affect the structure or function of the body are subject to requirements for drugs, as defined in section 201(g)(1) of the FD&C Act, and biological products under section 351 of the PHS Act, including applicable premarket review and approval requirements. We also direct your attention to FDA’s Public Safety Notification on Exosome Products, available at https://www.fda.gov/vaccines-blood-biologics/safety-availability-biologics/public-safety-notification-exosome-products. FDA issued this public safety notification following multiple reports of serious adverse events experienced by patients who were treated with exosome products.

This letter is not intended to be an all-inclusive list of deficiencies that may exist in connection with your umbilical-cord derived product. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure full compliance with the FD&C Act, PHS Act, and all applicable regulations.

This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address these matters may result in action without further notice including, without limitation, seizure and/or injunction.

Send your electronic response and any questions regarding this letter to CBER’s Office of Compliance and Biologics Quality, Division of Case Management at CBERDCMRecommendations@fda.hhs.gov.