Frequently Asked Questions

Umbilical cord-derived Wharton’s jelly is an exciting new option for such therapies. Wharton’s jelly is a connective tissue located within the umbilical cord largely composed of extracellular matrix components, including collagen, chondroitin sulfate, hyaluronic acid, and sulfated proteoglycans. Wharton’s jelly is a promising and applicable biologic source for regenerative applications.

According to FDA’s 21 CFR § 1271.3, 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.

Under the Public Health Service Act (PHSA) and implementing regulations, the FDA regulates HCT/Ps. The HCT/P regulations require manufacturers to register their products, create donor eligibility criteria, and establish procedures, such as current good tissue practices (cGTPs), to prevent the spread of communicable diseases.

Products that fall under Section 351 are regulated similarly to drugs or devices which must have an Investigational New Drug Application (IND) in effect or acquire pre-market approval to be commercially marketed. Section 361 governs HCT/Ps that meet the criteria listed in 21CFR 1271.10(a). Products that fall under section 361 do not need an IND or premarket approval to be distributed because if they retain their primary functions for homologous use, they are considered a known quantity and thus would not warrant further investigation.

For structural tissue, minimal manipulation means that the processing of the HCT/P does not alter the original relevant characteristics of the tissue relating to the tissue's utility for reconstruction, repair, or replacement.

Yes. (…)

Yes. Lux Therapeutics is responsible for all steps in the manufacturing process that take place after recovery, including the processing, storage, labeling, packaging, and shipping of any product marketed by Lux Therapeutics.

Lux Therapeutics produces tissue allograft products regulated under Section 361 of the PHS Act. Amniotic membrane patches (Theramend) intended to for homologous use as a covering or barrier and umbilical cord Wharton’s jelly (Luxegen) intended for homologous use to provide cushioning and structural support to an affected site.