Glycosaminoglycans
Predominantly hyaluronic acid, with chondroitin and dermatan sulfate. These hold the water that gives the tissue its gel character.
A clinician’s reference
What is Wharton’s jelly?
What the tissue is, what it contains, how perinatal tissue is regulated, and what a practice should require of any supplier — including us.
Wharton’s jelly is the gelatinous connective tissue that surrounds and cushions the vessels inside the umbilical cord. It was described in 1656 by Thomas Wharton, and for most of the intervening centuries it was discarded with the placenta.
It is discussed now because of what it is made of rather than what it has been shown to do, and a practice evaluating this category is better served by that distinction than by a brochure. This page sets out what the tissue is, how perinatal tissue is regulated in the United States, and what a practice should require of any supplier — including us. It names no manufacturer, no product and no price, because those belong in a conversation with a person who knows your practice, not on a page anyone can read.
A material, a regulatory pathway, and a paperwork standard. In that order.
What the tissue contains
The components most often described in the literature are structural rather than pharmacological.
Collagens
Principally types I and III — the fibrillar collagens that give connective tissue its tensile structure.
Proteoglycans
With associated glycoproteins: the matrix scaffolding that organises everything above into a tissue rather than a solution.
Cellular content
Fibroblast-like and mesenchymal stromal cells are present in fresh cord tissue. What survives a given processing and cryopreservation method is a question for that supplier’s own data.
That last point is the one most often skipped. “Contains mesenchymal stem cells” is a statement about umbilical cord tissue in the body. Whether it remains true of a particular vial, after a particular manufacturer’s processing, is a separate question with a separate answer — and the only acceptable form of that answer is their data.
How it is regulated
In the United States, human cells, tissues and cellular and tissue-based products — HCT/Ps — are regulated under 21 CFR Part 1271. The practical question is which of two pathways a product sits in.
Section 361 — regulated as tissue
No premarket approval. To qualify, a product must be minimally manipulated, intended for homologous use only, not combined with another article, and must not have a systemic effect or depend on the metabolic activity of living cells for its primary function.
Section 351 — regulated as a drug or biologic
Everything falling outside those criteria. It requires an approved Biologics License Application, which in turn requires clinical trials. There is no third category and no informal middle ground.
The distinction is not paperwork — it decides what may lawfully be said and done. A perinatal product marketed for a systemic effect, or for a use unrelated to the tissue’s original function, is by that description a 351 product, and the FDA has said so repeatedly about this category.
The moment a supplier tells a practice what their tissue treats, they have described a drug.
What to require of any supplier
These are the questions we would want a practice to put to us, which is the only reason they are worth publishing.
Donor eligibility, in writing
Screening and testing under Part 1271 Subpart C, with the eligibility determination available for the lot you were sent.
Establishment registration
Tissue establishments register with the FDA and list their HCT/Ps. This is publicly verifiable, and it is worth verifying.
A certificate for your lot
A certificate of analysis for the lot actually shipped to you — not a specimen certificate from a different one.
Processing described plainly
Enough detail to assess “minimal manipulation” yourself. A supplier who will not describe their process is telling you something.
Accreditation, understood correctly
AATB accreditation is a voluntary industry standard and a good signal. It is not FDA approval, and a supplier who blurs the two has answered a question you did not ask.
Every claim, sourced
If a mechanism is asserted, ask which paper. If a number is quoted, ask what it was measured on, and in what.
What this page deliberately does not say
It does not tell you what Wharton’s jelly treats, what results to expect, or what to charge for it. Perinatal tissue products are not FDA approved or licensed for the prevention, treatment, diagnosis, mitigation or cure of any disease, and a page implying otherwise would be describing an unapproved drug. Clinical decisions belong to the licensed professional who examined the patient, working from the primary literature and their own judgement.
Product availability, permitted uses and applicable requirements vary by jurisdiction. Everything the network carries is for licensed professionals and qualified purchasers only.
Pricing is not published here and will not be. It is contractual, it varies by practice and by volume, and it is settled in a conversation with the associate who will be looking after your account.
Tell us what you need.
Tell us the category and we’ll put the right person in front of you, with the documentation, before anyone quotes anything.