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.
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FAQ
What does homologous use mean?
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.
How is HTC/P regulated?
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.
What’s the difference between 351 and 361?
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.
What does minimally manipulated mean?
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.
Does Ponya Therapeutics manufacture its own products?
Yes. Ponya 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 Ponya Therapeutics.
What tissue types does Ponya Therapeutics produce?
Ponya 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 Wharton’s jelly (Luxegen™) intended for homologous use to provide cushioning and structural support to an affected site.
Disclaimer
Ponya Therapeutics, LLC products are intended for homologous use only as defined by FDA regulations. Our products are not intended to diagnose, treat, cure, or prevent any disease or medical condition and are not classified as drug products by the U.S. Food and Drug Administration (FDA). Ponya Therapeutics, LLC does not offer mesenchymal stem cells or Wharton’s Jelly as a cure for any condition, disease, or injury. No statements made on this website or in any related marketing materials have been evaluated or approved by the FDA. The content provided is for educational and informational purposes only and does not constitute medical advice. We do not diagnose or treat any condition via this website, printed materials, or telephone communications. Ponya Therapeutics makes no claims—express or implied—regarding the safety, efficacy, or regulatory status of any specific use or application of our products. It is essential that all healthcare decisions be made in consultation with a licensed physician. We encourage patients and providers to perform their own due diligence when considering the use of our products.
