What is Wharton's jelly?

Wharton's jelly is the gelatinous connective tissue that surrounds and cushions the vessels running through the umbilical cord. It is named for Thomas Wharton, who described it in 1656, and for most of the time since it was discarded with the placenta.

It is discussed now because of what it is made of. That is a narrower statement than the one usually made about it, and the difference between those two statements is what this piece is about.

What is actually in it

The components most often described in the literature are structural rather than pharmacological. It is a matrix — the scaffolding tissue is built on — rather than an active ingredient.

• Glycosaminoglycans, predominantly hyaluronic acid, with chondroitin and dermatan sulfate. These hold the water that gives the tissue its gel character.
• Collagens, principally types I and III — the fibrillar collagens that give connective tissue its tensile structure.
• Proteoglycans and associated glycoproteins, which organise the above into a tissue rather than a solution.
• Cellular content: fibroblast-like and mesenchymal stromal cells are present in fresh cord tissue.

The regulation is the interesting part

In the United States, human cells, tissues and cellular and tissue-based products — HCT/Ps — are regulated under 21 CFR Part 1271. There are two pathways, and which one a product sits in decides what may lawfully be said about it.

• 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: everything outside those criteria. Regulated as a drug or biologic, requiring an approved Biologics License Application — which requires clinical trials.

Homologous use is the hinge. 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 you what their tissue treats, they have described a drug.

What this means if you are a patient

It means that anyone offering you a perinatal tissue product as a treatment for a named condition is making a claim the regulatory framework does not support, and that you are entitled to ask them about it directly. These products are not FDA approved or licensed for the prevention, treatment, diagnosis, mitigation or cure of any disease.

It also means this page cannot tell you whether anything here is right for you, and would be doing you a disservice if it tried. That conversation belongs with a qualified healthcare professional who has examined you and can weigh your history against the actual evidence.

What this means if you are a practice

It means the diligence is documentary, and it is the same list regardless of who is selling. Ask for the donor eligibility determination under Part 1271 Subpart C. Ask whether the establishment is FDA-registered and listed, which is publicly verifiable. Ask for a certificate of analysis for the lot you were actually sent rather than a specimen from another one. Ask for the processing described plainly enough that you can assess minimal manipulation yourself.

And ask what they are not claiming. A supplier who can state the boundary of their own evidence is telling you they know where it is.

Why we wrote it this way

There is a version of this article that would perform better. It would open with a number, name a condition, and finish with a call to action. We did not write it, because every honest sentence available on this subject is a sentence about material and paperwork, and the ones that are not honest are the ones the FDA has spent a decade writing letters about.

This applies to us as much as to anyone else. If we would not publish a claim here, we would not want an associate making it in a room.