REGENERATIVE STEM CELL THERAPY

REGENERATIVE STEM CELL THERAPY

By jdcline On February 28, 2017
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iSTEMCELL 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.
1271.3 (c)
(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.
1271.10 (2)
(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 Stem cells s 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


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Human Umbilical Cord Tissue Stem Cell Injection Therapy | Stem Cell Injections | iSTEMCELL FOUNDATION | Regenerative Stem Cell Therapy | Chronic Back Pain Releif Protocol Including Stem Cell Injections | Advantages of Human Umbiilical Cord Tissue | Are Stem Cell Injections covered by HSA Accounts?

 

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iSTEMCELL is a non-goverment portal designed to help connect individuals looking to providers who offer different options. Stem Cells are not FDA approved for everything but but we will provide testomonials of as many people who have used them as well as information from providers who treat with them. Tissue Banks are regulated by the FDA and have an approval process for their operations. ISTEMCELL is an online platform designed to connect providers and clients. Its not offering stem cell therapy as a cure for any condition, disease, or injury. No statements or implied treatments on this website have been evaluated or approved by the FDA. This website contains no medical advice. All statements and opinions provided by this website are provided for educational and informational purposes only and we do not diagnose or treat via this website or via telephone. iSTEMCELL does not claim that any applications, or potential applications, using stem cells are approved by the FDA, or are even effective. We do not claim that these treatments work for any listed nor unlisted condition, intended or implied. It’s important for potential patients to do their own research based on the options that we present so that one can make an informed decision. Any decision to participate in any protocols is completely voluntary and is between you and the provider of your choice.ueTCEL