Innate Healthcare Institute

Selected passages from the FDA letter

Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.

Passage 1

On your website, https://innatehealthcare.org, you provide the following statements: - "At Innate Healthcare Institute, we combine an effective blend of integrative medicine and regenerative stem cell medicine, treating Autism at its root." - "Stem cell therapy has really helped our son with his autism" - "Stem cell therapy with human umbilical cord tissue derived mesenchymal stem cells (UC-MSCs) corrects the inflammatory process by modulating the immune system from a pro-inflammatory attacking state to an anti-inflammatory healthy state. They also have the ability to regenerate damage done from the autoimmune attack. Stem cells do this by secreting healing activators such as growth factors, cytokines, and exosomes to the surrounding environment." - "Stem cell therapy for autism can lead to improvement in cognitive ability, behaviors, and sociability." - "Regenerative cell medicine has the potential to help with many conditions such as pain due to osteoarthritis, tendinopathy/tendonitis, degenerative disc disease, herniated discs, neuropathy, fractures, muscle injuries, ligament and tendon injuries, COPD, peripheral neuropathy, sexual dysfunction, autoimmune conditions, heart disease, and many more."

Passage 2

your UC-MSCs 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.

Passage 3

your UC-MSCs product fails to meet the criterion that the HCT/Ps be "intended for homologous use only," which 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 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 product is intended for use in the treatment of autism as well as other diseases or conditions, which is not a basic function of the umbilical cord in the donor.

Passage 4

your 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 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 product safely for its intended purposes. Accordingly, your 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).

Passage 5

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 regulated as drugs as defined in section 201(g)(1) of the FD&C Act and biological products under section 351 of the PHS Act and and are subject to premarket review and approval requirements.