What Wharton's Jelly Is, and What It Isn't
Wharton's jelly is a matrix tissue, not a cell therapy. Published research on its composition is still early, and most studies to date have been small. We describe our products in terms of what the tissue is and how it is processed.
Products derived from Wharton's jelly are generally marketed as minimally manipulated tissue allografts. Whether a specific intended use meets the federal criteria for that category, including minimal manipulation and homologous use, is a determination your clinic and its counsel need to make for your own case.
Our Wharton's Jelly Product Line
We distribute four Wharton's jelly formats, each with different handling and presentation.
Full specifications and handling instructions for each format are on the individual product pages.
- Bio PRP Jelly: 3 mL vial, listed at 70 mg tissue weight, cryopreserved, supplied ready to use
- Bio Flex: higher-concentration format, offered in 1 mL and 2 mL vials; tissue weight is confirmed against the lot certificate of analysis
- Bio Flow: Wharton's jelly-derived formulation offered in 1 mL and 2 mL formats, with composition documentation provided to verified accounts
- Bio DPM: lyophilized (freeze-dried) format described by the supplier as shelf-stable without cryogenic storage
Donor Screening, Recovery, and Cold Chain
Tissue is donated by consenting mothers at the time of a scheduled, full-term cesarean delivery. Donation does not affect a mother's option to also bank cord blood. Donors are screened through medical and social history review and serology testing for communicable disease.
Recovery is performed by trained, licensed personnel, and tissue is processed within 48 hours of recovery. Processing is described by the supplier as following FDA regulations and AATB and AABB guidelines. Cryopreserved formats are frozen using a slow-rate process, stored at -80 degrees Celsius, and shipped overnight on dry ice in validated containers.
What to Verify Before You Order
Each lot carries a unique identifier, and samples from each lot are sent to a third-party laboratory for sterility testing. Lots are held in quarantine until testing is complete and internal release criteria are met. Ask for the certificate of analysis and lot release record tied to your specific lot.
Ordering requires account verification by NPI number, and pricing is available to verified accounts rather than published.
These products are not FDA approved or licensed for any disease or condition. Information on this page is for licensed healthcare professionals and is not medical or legal advice.
Frequently asked questions
Are your Wharton's jelly products labeled as stem cell products?+
No. We describe them as tissue allografts. Documentation for commercial cord tissue allografts generally does not support stem cell claims, so we avoid that label.
How are Wharton's jelly products shipped?+
Cryopreserved formats ship overnight on dry ice in validated containers and are stored at -80 degrees Celsius. Bio DPM is lyophilized and described by the supplier as shelf-stable without cryogenic storage.
What's the difference between Bio PRP Jelly, Bio Flex, and Bio Flow?+
They differ in vial format and concentration positioning. Bio PRP Jelly is a 3 mL vial listed at 70 mg tissue weight. Bio Flex and Bio Flow are each offered in 1 mL and 2 mL formats, with specific composition data provided on request.
Who can order Wharton's jelly products from Precision Biologics?+
Licensed clinics, medspas operating under physician supervision, and physicians, after account verification by NPI number.