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USA ONLY: The mesenchymal and umbilical cord blood stem cells used in this study are human cells, tissues, or cellular and tissue-based products (HCT/Ps) as defined in 21 CFR § 1271.3(d). Under 21 CFR Part 1271, HCT/Ps are not subject to licensure or IND requirements if certain criteria are met (21 CFR § 1271.10). These requirements include autologous use (use by the cell donor), or if used for other patients, the HCT/Ps must be “not more than minimally manipulated” and labeled for use for “homologous use only”. They may also not be used for a purpose requiring their “metabolic” activity. StemLab S.A. mesenchymal and umbilical cord stem cells shipped to the United States of America have not been “more than minimally manipulated”. StemLab S.A. labels and intends its cells which are used within the United States of America only for homologous and non-metabolic purposes. StemLab S.A. does not interfere with the practice of medicine by individual physicians who use StemLab products, and who may do so according to their own medical training and informed choice.

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