Wharton’s Jelly Cells
The Gold Standard in Regenerative Aesthetics.
Information on Wharton’s Jelly as a Human Cellular and Tissue-Based Product (HCT/P)
Wharton’s Jelly is the gelatinous connective tissue found in the umbilical cord. It is derived from donated umbilical cords following healthy births and is processed as an HCT/P under FDA regulations. Establishments handling Wharton’s Jelly must comply with 21 CFR Part 1271, which governs registration, donor screening, and good tissue practices. However, most Wharton’s Jelly products do not meet the criteria for regulation solely under Section 361 of the Public Health Service Act (minimal manipulation, homologous use only, not combined with other articles, and no systemic effect or dependence on metabolic activity of living cells except in autologous, allogeneic, or reproductive uses).
As such, they are typically regulated as biological products under Section 351, requiring a Biologics License Application (BLA) for marketing, which includes demonstration of safety, purity, and potency through clinical trials. To date, no Wharton’s Jelly products have received FDA approval for regenerative or aesthetic applications.
Research has analyzed Wharton’s Jelly’s composition, which includes growth factors, cytokines, hyaluronic acid (HA), and extracellular vesicles. Studies, such as Gupta et al. (2020), have compared cytokine levels in Wharton’s Jelly to those in bone marrow and adipose-derived materials, noting variations in concentrations of elements like RANTES, MCP-1, IL-1RA, and PDGF-AA. These findings are from in vitro or preclinical investigations and do not establish clinical safety or effectiveness for any specific use.
Composition and Research Observations
Wharton’s Jelly contains naturally occurring components, including:
- Hyaluronic Acid (HA): Reported at average levels of approximately 8.7 μg/mL in certain formulations, as observed in laboratory analyses.
- Growth Factors: Includes elements such as VEGF, HGF, FGF-7, TGF-α, TGF-β1, and others, identified through biochemical assays.
- Cytokines: Features anti-inflammatory markers like IL-1RA and TIMP-1/2, as quantified in comparative studies.
- Other Elements: Extracellular matrix components and vesicles, examined in research settings.
These observations are derived from scientific literature and are not intended to imply any therapeutic effects or outcomes. All uses of Wharton’s Jelly must adhere to homologous intent, where the product performs the same basic function in the recipient as in the donor (e.g., cushioning or structural support in connective tissue contexts). Non-homologous uses, such as for skin, hair, or anti-aging applications, would require FDA approval as a biological drug.
Considerations for Professional Use
Medical professionals, including those in med spas and surgical practices, may encounter Wharton’s Jelly in research or investigational contexts. Reported applications in literature include topical or injectable forms in preclinical models, but these are not FDA-approved indications.
Any use should be limited to investigational settings under an Investigational New Drug (IND) application or in compliance with the practice of medicine, where applicable. Providers must ensure donor screening, testing for communicable diseases, and proper labeling per FDA guidelines.
This information is provided for educational purposes only and does not constitute medical or legal advice. Professionals should verify compliance with current regulations, given ongoing FDA enforcement actions.
Important Disclaimers
- Wharton’s Jelly products are not approved by the FDA for any medical or aesthetic use, including skin rejuvenation, hair restoration, or anti-aging.
- These products are not intended to diagnose, treat, cure, or prevent any disease or condition.
- The FDA has issued warnings about unapproved regenerative medicine products, including those derived from umbilical cords, due to potential risks such as infections, immune reactions, and lack of proven safety or efficacy.
- Consult FDA guidance, conduct thorough risk assessments, and obtain informed consent from patients. Individual responses may vary, and use is at the discretion of licensed healthcare providers.
- For the latest regulatory information, visit FDA.gov or contact the FDA directly.