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IntelliCell BioSciences, Inc. Message Board

  • athec_99 athec_99 Jul 1, 2014 9:05 AM Flag

    FDA Warning Letter

    Read it and weep, SVFC bagholders.

    IntelliCell’s adipose derived stem cells are human cells, tissues, or cellular and tissue-based products (HCT/Ps) as defined in 21 CFR 1271.3(d). However, this cellular product does not meet all of the criteria in 21 CFR 1271.10(a) and therefore is not regulated solely under section 361 of the Public Health Service Act (PHS Act) [42 U.S.C. 264] and the regulations in 21 CFR Part 1271. Specifically, your processing alters the relevant characteristics of the adipose tissue relating to the tissue’s utility for reconstruction, repair, or replacement. Therefore the processing would not meet the definition of minimal manipulation for structural tissue such as adipose tissue. As a result, the IntelliCell product does not meet the criterion in 21 CFR 1271.10(a)(1).

    In addition, some of the treatments you offer do not meet the definition of homologous use in 21 CFR 1271.3(c) (e.g., use of the IntelliCell product to treat osteoarthritis, gum recession). Also, records collected during the inspection indicate clinical uses of the IntelliCell product involving IV administration or administration (b)(4) of adipose-derived stem cells. These uses would not likely be considered homologous use. As a result, the IntelliCell 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 PHS Act [42 U.S.C. 262(i)] that cannot qualify for regulation solely under section 361 of the PHS Act and 21 CFR Part 1271.

    Please be advised that in order to lawfully market such a biological drug 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 (IND) application in effect as specified by F

    Sentiment: Strong Sell

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