Dynamic Stem Cell Therapy

Selected passages from the FDA letter

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

Passage 1

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).

Passage 2

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).

Passage 3

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.

Passage 4

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.