“(a) An HCT/P is regulated solely under section 361 of the PHS Act and the regulations in this part if it meets all of the following criteria:
(1) The HCT/P is minimally manipulated;
(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;
(3) The manufacture of the HCT/P does not involve the combination of the cells or tissues with another article, except for water, crystalloids, or a sterilizing, preserving, or storage agent, provided that the addition of water, crystalloids, or the sterilizing, preserving, or storage agent does not raise new clinical safety concerns with respect to the HCT/P
(4) Either:
(i) The HCT/P does not have a systemic effect and is not dependent upon the metabolic activity of living cells for its primary function; or
(ii) The HCT/P has a systemic effect or is dependent upon the metabolic activity of living cells for its primary function, and:
(a) Is for autologous use;
(b) Is for allogeneic use in a first-degree or second-degree blood relative; or
(c) Is for reproductive use.”
eCFR :: 21 CFR Part 1271 — Human Cells, Tissues, and Cellular and Tissue-Based Products
According to Title 21,
“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.”
Our unique procedure ensures that the original relevant characteristics of the tissue remain unaltered while avoiding the isolation of any components found in the tissue. Our highly skilled tissue processing scientists resize and suspend the tissue in a saline solution with cryopreservative, which is authorized by the FDA.
Throughout our manufacturing process, we dissociate the donated umbilical tissue and reduce it to a size that preserves the tissue’s inherent characteristics while maintaining its primary functions.
According to Title 21,
“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 function or functions in the recipient as in the donor.”
Scientific literature extensively supports Wharton’s jelly’s primary function as providing cushioning and structural support. Within the umbilical cord, Wharton’s jelly effectively cushions, safeguards, and insulates internal structures, such as the vein and arteries, from compression, torsion, and bending. When utilized in soft tissue defects, our product demonstrates these same functions by effectively cushioning and supporting the surrounding tissues.
According to Title 21,
“The manufacture of the HCT/P does not involve the combination of the cells or tissues with another article, except for water, crystalloids, or a sterilizing, preserving, or storage agent, provided that the addition of water, crystalloids, or the sterilizing, preserving, or storage agent does not raise new clinical safety concerns with respect to the HCT/P;”
Luxegen, our Wharton’s Jelly product, is only combine with saline and an approved cryopreservative, which are both acceptable according to the FDA.
According to Title 21,
“(i) The HCT/P does not have a systemic effect and is not dependent upon the metabolic activity of living cells for its primary function; or
(ii) The HCT/P has a systemic effect or is dependent upon the metabolic activity of living cells for its primary function, and:
(a ) Is for autologous use;
(b ) Is for allogeneic use in a first-degree or second-degree blood relative; or
(c ) Is for reproductive use.”
The primary purpose of Wharton’s Jelly in the donor tissue is to provide cushioning and protection to the umbilical cord from mechanical stress. Lux Therapeutics’ Wharton’s jelly product retains these properties. Due to the localized application of our product, it does not have a systemic effect on the recipient.
Lux Therapeutics upholds stringent donor acceptance criteria. Our screening process involves utilizing highly sensitive nucleic acid testing (NAT) to detect the presence of Hepatitis B virus (HBV), Hepatitis C virus (HCV), and HIV. We conduct a comprehensive evaluation of potential donors, carefully considering any high-risk behaviors. Our donor eligibility criteria are extensive, encompassing testing for anti-HIV1, anti-HIV2, HBsAg, anti-HBc-total, IgG/IgM, anti-HCV, RPR, syphilis, HTLV I/II, and West Nile Virus. Additionally, our products undergo sterility testing after packaging to ensure adherence to USP<85> standards.
Tissue tracking and traceability is mandated by the FDA, meaning that we must ensure that every tissue we provide to our customers can be traced back to its original donor and all records relevant to the donor.
At our facilities, we ensure stringent environmental control by consistently monitoring and maintaining temperature and humidity levels. All freezers and storage equipment undergo regular monitoring and maintenance. Our tissue processing takes place in an FDA-inspected facility equipped with cGMP-compliant equipment. Furthermore, our processing occurs within certified ISO 7 and ISO 5 cleanrooms, adhering to strict cleanliness standards.
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