Quality Assurance & Safety
Learn how we maintain industry-leading quality throughout our process from start to finish.
PHS Act
What are the criteria for HCT/P’s regulated under section 361 of the PHS Act and the regulations in 21 CFR Part 1271?
“(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
Compliance
Minimal Manipulation
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.
Homologous Use
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;"
At Luxegen, our Wharton’s Jelly product, is only combine with saline and an approved cryopreservative, which are both acceptable according to the FDA.
Non-Combination
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;"
At Luxegen, our Wharton’s Jelly product, is only combine with saline and an approved cryopreservative, which are both acceptable according to the FDA.
No Systemic Effect
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.
Donors
Donor Criteria
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.
Tissues & Traceability
Tissue Tracking & Traceability
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.
Facility
Luxegen Facility
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.
Certifications & Licenses
External Testing Facilities Certifications & Licenses
VRL Laboratories CLIA Expires 9.4.2023
Eurofins Denver FDA Registration Expires 12.31.2023
Leaders in Regenerative Health Products
13 Corporate Blvd NE
Atlanta, GA 30329
(229) 442-7210
info@luxtherapeutics.com
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Disclaimer: Lux Therapeutics, LLC products are purposed for homologous use ONLY. All products are not intended to be drug products that diagnose, treat, cure, or prevent any disease or condition. Lux Therapeutics, LLC does not offer Mesenchymal Stem Cells or Wharton’s Jelly as a cure for any condition, disease, or injury. No statements or implied treatments on our website or marketing material have been evaluated or approved by the FDA. This material 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, marketing material, or telephone. Lux Therapeutics, LLC does not claim that any applications, or potential applications, using our products are approved by the FDA, or are even effective. We do not claim that these treatments work for any listed or unlisted condition, intended or implied. It’s important for potential patients to do their own research based on the options that we present and consultation with their physician.