US Stem Cell Clinic, LLC FDA Warning (2017)

Detailed Analysis

False Claims and Regulatory Violations

During an inspection of your firm, US Stem Cell Clinic, LLC (USSC)1located at 12651 W. Sunrise Blvd., Suite 104, Sunrise, FL 33323, conducted between April 10 and May 11, 2017, the Food and Drug Administration (FDA) found that your firm recovers and processes adipose tissue, a structural tissue, from donors for autologous use.  Your firm uses(b)(4)to(b)(4)components from adipose tissue, which are further processed into stromal vascular fraction (SVF).  Your SVF product is generally administered intravenously or intrathecally for a variety of diseases or conditions.

Records gathered during the inspection reflect that your SVF product is intended to treat a variety of diseases and conditions, including, but not limited to, Parkinson’s disease, amyotrophic lateral sclerosis (ALS), chronic obstructive pulmonary disease (COPD), heart disease, and pulmonary fibrosis.  In addition, on your website you claim to “offer stem cell treatments” for “neurological . . . autoimmune . . . degenerative” and other conditions, including but not limited to “Parkinson’s, ALS . . . Rheumatoid Arthritis, Crohn’s, Colitis, Lupus . . . COPD, Diabetes, [and] Congestive Heart Failure.”  See http://usstemcellclinic.com.

In addition, your SVF product fails to meet the 21 CFR 1271.10(a) (2) criterion that the HCT/P be “intended for homologous use only, as reflected by the labeling, advertising, or other indications of the manufacturer’s objective intent.”  As noted above, the SVF product is intended for use in the treatment of a variety of diseases or conditions.  Because the SVF product is not intended to perform the same basic function or functions of adipose tissue, such as cushioning the body, using the SVF product for treatment of these diseases or conditions is not homologous use as defined in 21 CFR 1271.3(c).  As a result, your SVF product does not qualify for regulation solely under section 361 of the PHS Act and 21 CFR Part 1271.

Potential Health Risks

Therefore, your SVF product is a drug under section 201(g) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) [21 U.S.C. 321(g)] and a biological product as defined in section 351(i) of the Public Health Service Act (PHS Act) [42 U.S.C. 262(i)].2It is also a human cell, tissue, or cellular or tissue-based product (HCT/P) as defined in 21 CFR 1271.3(d).3

Regulatory Context

Your SVF product does not meet all of the criteria in 21 CFR 1271.10(a), and therefore does not qualify for regulation solely under section 361 of the PHS Act [42 U.S.C. 264] and the regulations in 21 CFR Part 1271.  Specifically, your SVF product does not meet the minimal manipulation criterion set forth in 21 CFR 1271.10(a)(1) and defined for structural tissue, such as adipose tissue, in 21 CFR 1271.3(f)(1).  Your product does not meet this criterion because your processing alters the original relevant characteristics of the adipose tissue relating to the tissue’s utility for reconstruction, repair, or replacement.

Please be advised that in order to lawfully market a drug that is a biological product, a valid biologics license must be in effect [21 U.S.C. 355(a); 42 U.S.C. 262(a)].  Such licenses are issued only after a showing of safety and efficacy for the product’s intended use.  While in the development stage, such products may be used 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); 21 CFR Part 312].  Your SVF product is not the subject of an approved biologics license application (BLA)(b)(4).

Additionally, during the inspection, FDA investigators documented evidence of significant deviations from current good manufacturing practice (CGMP) and current good tissue practice (CGTP) between December 8, 2015, and April 17, 2017, in the manufacture of at least(b)(4)lots of your SVF product.  These deviations from CGMP and CGTP include deviations from section 501(a) (2) (B) of the FD&C Act, and 21 CFR Parts 210, 211, and 1271.  Many of these deviations were the same or similar to the observations listed on the Form FDA 483 issued to you at the conclusion of FDA’s previous inspection of your firm between October 22 and December 7, 2015.