Mother Stem Institute, Corp.

Selected passages from the FDA letter

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

Passage 1

These claims on your website establish that you intend your SVF product to be used for the treatment of various diseases and conditions, including Alzheimer’s disease, Type I/II Diabetes, Lupus, and Rheumatoid Arthritis. These intended uses indicate that the product is a drug under section 201(g)(1)(B) and (C) of the FD&C Act [21 U.S.C. § 321(g)(1)(B)-(C)] because it is intended for use in the mitigation, treatment, or prevention of disease and because it is intended to affect the structure or function of the body. Additionally, your product is a biological product as defined in section 351(i) of the Public Health Service Act (PHS Act) [42 U.S.C. § 262(i)] because it is applicable to the prevention, treatment, or cure of a disease or condition of human beings.

Passage 2

For example, you do not qualify for the exception in 21 CFR 1271.15(b), which provides that an “establishment that removes HCT/P’s from an individual and implants such HCT/P’s into the same individual during the same surgical procedure” is excepted from FDA regulations in 21 CFR Part 1271. The HCT/P that you remove from patients – adipose tissue – is different from the HCT/P that you later administer to patients – your SVF product. In its original form, adipose tissue is a structural tissue composed of cells surrounded by a reticular fiber network and interspersed small blood vessels.***1*** According to your response to FDA’s record request, you break down that adipose tissue using enzymatic digestion and isolate cellular components. What remains of the adipose tissue following your enzymatic digestion, filtration, and centrifugation is not considered tissue. Rather, the organized structure of the adipose tissue has been destroyed and, biologically, what remains would be a heterogeneous collection of cells.***2*** Therefore, your SVF product is not “such HCT/P” within the meaning of 21 CFR 1271.15(b), and the same surgical procedure exception does not apply.

Passage 3

Furthermore, your SVF 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). Adipose tissue is typically defined as a connective tissue composed of clusters of cells (adipocytes) surrounded by a reticular fiber network and interspersed small blood vessels, divided into lobes and lobules by connective tissue septa; therefore, the FDA considers adipose tissue to be a structural tissue for the purpose of applying the regulatory framework.***3*** Additionally, adipose tissue contains other cells, including preadipocytes, fibroblasts, vascular endothelial cells, and macrophages.***4*** Adipose tissue provides cushioning and support for other tissues, including the skin and internal organs, stores energy in the form of lipids, and insulates the body, among other functions. Structural tissues, like adipose tissue, may contain both extracellular matrix and cellular components, and any alteration of these components that relates to the structural tissue’s utility for reconstruction, repair, or replacement generally would be considered more than minimal manipulation. To assess whether a processing step alters the original relevant characteristics of a structural tissue relating to its utility for reconstruction, repair, or replacement, the effects of the processing on the properties that contribute to the specific tissue’s function in the donor are considered. Thus, whether processing of adipose tissue would meet the regulatory definition of minimal manipulation takes into consideration whether the processing alters the original relevant characteristics of the adipose tissue related to its utility to provide cushioning and support to the body. Adipose tissue is processed by Mother Stem Institute using enzymatic digestion to isolate cellular components of adipose tissue, i.e., SVF. This processing to isolate non-adipocyte or non-structural components from adipose tissue (with or without subsequent cell culture or expansion) is more than minimal manipulation because removing the adipocytes and structural components alters the original relevant characteristics relating to the tissue’s utility to provide cushioning and support. Unlike adipose tissue, your SVF product does not provide cushioning and support.***5***

Passage 4

To lawfully market a drug that is also a biological product, a valid biologics license must be in effect [42 U.S.C. § 262(a)]. Such licenses are issued only after a demonstration that the product is safe, pure, and potent. While in the development stage, such products may be distributed for clinical use in humans only if the sponsor has an investigational new drug application (IND) in effect as specified by FDA regulations [21 U.S.C. § 355(i); 42 U.S.C. § 262(a)(3); 21 CFR Part 312]. Your SVF product is not the subject of an approved biologics license application (BLA) nor is there an IND in effect.

Passage 5

Furthermore, your SVF 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 SVF product is intended for 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 SVF product safely for its intended purposes. Accordingly, your SVF product fails to bear adequate directions for its intended uses and, therefore, is misbranded under section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)]. Misbranding your SVF 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)].