REGENERATIVE STEM CELL THERAPY
REGENERATIVE STEM CELL THERAPY
By jdcline On February 28, 2017
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uses a biotechnology company specializing in the harvesting and isolation of stem cells
by which innovative products are developed and natural regenerative therapies are made possible. These products contain cells, stem cells, and growth factors which may serve as a therapy for a variety of degenerative diseases and disorders.
The Tissue Bank is required to follow federal regulations as defined by the FDA in 21 C.F.R. 1271. to keep its licenses. See below.
(c) Homologous use means the repair, reconstruction, replacement, or supplementation of a recipient’s cells or tissues with an HCT/P that performs the same basic functions in the recipient as in the donor.
1271.3 (f), (1), (2)
(f) Minimal manipulation means: (1) For structural tissue, processing that does not alter the original relevant characteristics of the tissue relating to the tissue’s utility for reconstruction, repair, or replacement; and (2) For cells or nonstructural tissues, processing that does not alter the relevant biological characteristics of cells or tissues.
(2) The HCT/P is intended for homologous use only, as reflected by the labeling, advertising, or other indications of the manufacturer’s objective intent
http://istemcell.com/wp-content/uploads/2017/02/tissue-bank-license-300x188.png 300w" sizes="(max-width: 136px) 100vw, 136px"> Tissue Bank License
is required by the government, and strict guidelines and procedures must be followed and maintained to receive the licensed held by the tissue bank our Stemcells are procured for our providers.
STEM CELL RELATED DOCUMENTS, CERTIFICATIONS AND LICENSES
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FDA TITLE 23 PART 1271
The product(s) you have purchased from tissue bank, is/are specifically intended to be regulated under 21 C.F.R. 1271, in its entirety and, in particular, 21 C.F.R. 1271.10 as human cells, tissues, and cellular and tissue-based product(s) (HCT/Ps).
The product(s) you have purchased is/are intended by to only be put to a HOMOLOGOUS USE, as that term is defined in 21 C.F.R. 1271.3(c). Under 21 C.F.R. 1271.3(c), HOMOLOGOUS USE is defined to mean “the repair, reconstruction, replacement, or supplementation of the recipient’s cells with an HCT/P that performs the same basic functions in the recipient as in the donor.” For more information visit invitrx. com