FAQ
NO, this is a human tissue allograft sourced from Wharton’s jelly, a mesenchymal connective tissue found in the umbilical cord. While this tissue is rich in native cell populations and may provide some regenerative properties, its main function is to protect the vasculature in the umbilical cord from mechanical stress.
When transplanted directly at the site of a connective tissue defect, or injury, (via syringe) our Wharton’s jelly products will cushion and support surrounding tissues while providing a structural scaffold which the body can use to repair itself.
Minimally manipulated Wharton’s jelly products such as Vitacell & Vitacell Pro contain collagen particulates that may present a clotting risk when administered intravenously.
Additionally, intravenous administration will present a systemic effect and thus would not qualify under Section 361 of the PHS (Public Health Service) Act.
Vitacell products do not treat or cure any disease or condition. Similar to a transplant, Vitacell & Vitacell Pro performs the same function in the recipient as it did in the donor (provide cushioning and structural support). Learn more on our Products page.
No, Vitacell and Vitacell Pro are regulated under Section 361 of the PHS Act. This regulation is for HCT/Ps (Human Cell and Tissue Products) that are minimally manipulated and are intended for homologous use only.
The rationale for this regulation is that HCT/Ps that meet the 361 criteria do not pose a significant risk to public health or safety because these products can be “reasonably expected to perform appropriately”. Read more on 361 regulation here.
If you are interested in the history and introduction of 361 regulation, read the comment section in this FDA statement from 2001 entitled “Human Cells, Tissues, and Cellular and Tissue-Based Products; Establishment Registration and Listing”.
We remove the red blood cells from the umbilical cord, disassociate the tissue so that the particulates are sufficiently small to flow through a syringe. We do not remove anything from the tissue so that all of the original components are still present and we do not add anything save saline, which is expressly allowed by the FDA.
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