Are Wharton’s Jelly Products FDA Approved?

No Wharton’s jelly product sold in the United States today has received FDA approval as a drug or biologic. The products you see advertised at orthopedic clinics, pain management offices, and regenerative medicine centers exist in a regulatory gray zone, marketed under tissue-banking rules that were never designed to cover therapeutic claims. That distinction matters enormously for anyone considering a Wharton’s jelly injection, because it means these products have not gone through the rigorous safety and efficacy testing the FDA demands before a treatment can be called “approved.”

What Wharton’s Jelly Actually Is

Wharton’s jelly is the soft, gel-like connective tissue found inside the umbilical cord. It surrounds and cushions the cord’s blood vessels, and it is rich in a type of extracellular matrix made largely of collagen and hyaluronic acid. The tissue also contains a population of cells called mesenchymal stromal cells, sometimes referred to as mesenchymal stem cells or MSCs, which researchers have studied extensively for their potential to modulate inflammation and support tissue repair.¹ Because the umbilical cord is normally discarded after birth, Wharton’s jelly can be collected without an invasive procedure on a donor, which makes it attractive as a raw material for regenerative medicine.

Why These Products Are Not FDA Approved

The FDA draws a sharp line between two categories of human tissue products. On one side are what the agency calls “361 HCT/Ps,” which stands for human cells, tissues, and cellular and tissue-based products regulated under Section 361 of the Public Health Service Act. These products can be marketed without premarket approval as long as they meet a set of strict criteria: the tissue must be minimally manipulated, intended only for homologous use (meaning it does the same job in the recipient that it did in the donor), and it cannot be combined with other drugs or devices. Tissue banks that follow these rules register with the FDA and comply with good tissue practices, but they do not need to prove their products work for any specific disease.

On the other side of the line are “351 products,” which are biological drugs. If a tissue product is more than minimally manipulated, or if it is advertised for a non-homologous use like treating arthritis or healing tendons, the FDA considers it a drug. That triggers the full regulatory pathway: preclinical studies, phased clinical trials, and eventually a biologics license application before the product can be legally marketed with therapeutic claims.

Most commercial Wharton’s jelly products attempt to stay on the 361 side of that line. They are processed under tissue-banking standards, packaged as allografts (transplant tissue from a donor), and distributed to clinics. The problem is that the therapeutic claims made around them, pain relief, cartilage repair, anti-inflammatory effects, often sound like drug claims. The FDA has repeatedly stated that marketing an HCT/P for uses beyond its homologous function converts it into an unapproved biologic, regardless of how the tissue itself was processed.

What Is Actually in the Vial

One of the biggest gaps between marketing and reality involves what commercial Wharton’s jelly products contain. Clinics frequently describe these injections as “stem cell therapy,” implying that the vial is packed with living, functional stem cells ready to regenerate damaged tissue. Laboratory analysis tells a different story.

A 2025 study that examined six commercially available, minimally manipulated Wharton’s jelly products found total cell counts ranging from roughly 3,400 to 111,000 cells per cubic centimeter. Of those, between zero and about 19 percent were viable, meaning alive. The absolute number of living cells topped out at around 18,000 per cubic centimeter in the richest sample. The researchers concluded that these products are “virtually devoid of viable cells.”²

To put those numbers in perspective, researchers working on actual stem cell therapies typically need at least ten million MSCs for a local injection and somewhere between 70 and 190 million for an intravenous infusion to achieve a measurable effect. Those doses require intentionally isolating stem cells from fresh tissue and growing them in a lab, a process called expansion. Minimally manipulated commercial products do not undergo expansion, because doing so would push them out of the 361 tissue-banking category and into the 351 drug category, triggering the need for FDA approval.²

What the vial does contain in meaningful quantities is extracellular matrix proteins, mainly collagen and hyaluronic acid. Whether that matrix alone provides a therapeutic benefit distinct from, say, a standard hyaluronic acid injection is an open question without a clear answer from controlled trials.

The Scale of Direct-to-Consumer Marketing

Despite the absence of FDA approval, the market for these products is large and growing. A 2021 survey identified 1,480 U.S. businesses operating across 2,754 clinics that were selling purported stem cell treatments, a more than fourfold increase from five years earlier. The vast majority of these products lacked both FDA approval and convincing evidence of safety and efficacy.³ Wharton’s jelly products are a significant slice of this market, though they sit alongside other perinatal products derived from amniotic fluid, amniotic membrane, and umbilical cord blood.

A separate analysis focused specifically on perinatal stem cell products found that a substantial number of businesses continued to market these unapproved products even after the FDA’s period of enforcement discretion ended. That enforcement discretion period was a grace window the FDA gave the industry to come into compliance with regulations. Once it closed, the expectation was that companies would either stop making drug claims or file for proper approval. Many did neither.⁴

This creates a confusing environment for patients. A clinic that says it offers “Wharton’s jelly therapy” or “umbilical cord stem cells” sounds legitimate, especially when the products come from registered tissue banks. And technically, the tissue bank may be operating within the law. The regulatory question often hinges on the claims being made at the point of care, not just at the point of manufacturing.

How Legitimate Clinical Trials Work Differently

The research pipeline for Wharton’s jelly-derived MSCs does exist, and it looks nothing like what happens at a commercial clinic. In legitimate trials, researchers isolate MSCs from fresh Wharton’s jelly tissue, expand them in the lab under strict manufacturing standards, and administer them at defined therapeutic doses. This process is expensive, tightly controlled, and requires an Investigational New Drug application with the FDA.

One active area of research is acute graft-versus-host disease, a life-threatening complication that can follow bone marrow transplants. A phase 1b trial enrolled adults with severe graft-versus-host disease who had not responded to standard steroid therapy. Patients received intravenous infusions of expanded Wharton’s jelly MSCs at doses ranging from two million to ten million cells per kilogram of body weight, given weekly over four weeks.⁵ The cells for this trial were manufactured under current good manufacturing practice standards using specialized culture systems.⁶

Notice the difference. In the trial, patients received tens of millions to hundreds of millions of verified, viable stem cells produced in a pharmaceutical-grade facility. In a commercial clinic, they receive a tissue product that may contain fewer than 20,000 living cells total, with no guarantee those cells are functional MSCs. These are fundamentally different interventions, even though both get called “Wharton’s jelly.”

What Early Clinical Evidence Shows for Knee Osteoarthritis

Knee osteoarthritis is the condition most frequently treated with commercial Wharton’s jelly injections, so the research here deserves a close look. A 2025 systematic review gathered all clinical trials published through the end of 2023 that used intra-articular injections of Wharton’s jelly MSCs for knee osteoarthritis or cartilage injury. Only six studies met the inclusion criteria, involving a total of 97 patients and 134 knees. Follow-up periods ranged from three months to four years. No serious adverse effects were reported, and patients showed improvements in pain and function scores. Radiological outcomes, meaning what imaging showed about the actual cartilage, were mixed.⁷

One of the more detailed studies in that review followed 16 patients with advanced osteoarthritis who received two doses of expanded Wharton’s jelly MSCs one month apart. At 12 months, MRI scans showed statistically significant improvements in cartilage loss, bone marrow lesions, joint effusion, synovitis, and subchondral sclerosis. Pain and function scores remained improved at 48 months. Only minor side effects were observed: one case of moderate knee effusion and one case of superficial phlebitis.⁸

These results are encouraging but have real limitations. The total body of evidence amounts to fewer than 100 patients across all studies. None of these trials included a placebo control arm, and the placebo effect in knee osteoarthritis is famously strong, especially with injection-based treatments. Patients who receive any injection into an arthritic knee tend to report feeling better for weeks or months, regardless of what is in the syringe. Without blinded, placebo-controlled trials, it is impossible to know how much of the improvement comes from the cells themselves versus the act of getting an injection plus the natural fluctuation of symptoms.

Critically, the studies that showed the most promising MRI changes used expanded, lab-cultured MSCs at therapeutic doses, not the minimally manipulated commercial products that clinics actually sell. Extrapolating from an expanded cell product to a commercial tissue allograft is not scientifically valid when the cell counts differ by several orders of magnitude.

Red Flags When Evaluating a Clinic

If you are considering a Wharton’s jelly injection, certain warning signs can help you distinguish a responsible provider from one that is overselling an unproven treatment.

Guaranteed outcomes: No legitimate provider can guarantee that a Wharton’s jelly injection will regenerate cartilage, eliminate pain, or avoid surgery. The evidence base is too thin to promise specific results.
“Stem cell” language: If a clinic describes a minimally manipulated Wharton’s jelly allograft as “stem cell therapy,” that is misleading. The product contains negligible numbers of living stem cells.
Long condition lists: Clinics that advertise the same injection for everything from back pain to erectile dysfunction to lung disease are not following evidence. The early-stage research is condition-specific, and most conditions on these lists have zero clinical trial data behind them.
No mention of FDA status: A responsible provider will be upfront that these products are not FDA approved for the condition being treated. If you have to ask, and the answer is evasive, that is informative.
High out-of-pocket cost with no insurance coverage: These treatments typically cost thousands of dollars per injection and are not covered by insurance, precisely because insurers require evidence of efficacy that does not yet exist.

Asking whether the clinic is participating in an FDA-registered clinical trial is also useful. If it is, you may have access to expanded, pharmaceutical-grade MSCs under careful monitoring at little or no cost. If it is not, you are paying for a commercial tissue product with no regulatory assurance that it works.

The Enforcement Gap

The FDA has not been entirely silent on this issue. The agency has issued warning letters to companies making unsupported therapeutic claims, and it took enforcement action against a handful of clinics during the late 2010s. But the sheer scale of the market, with thousands of clinics operating across the country, means enforcement is patchy at best. The FDA tends to prioritize cases where patients have been harmed, such as infections from contaminated products or serious adverse events. Clinics that sell Wharton’s jelly injections without dramatic safety incidents can operate for years without regulatory scrutiny.

This does not mean the products are safe simply because no one has been shut down. It means the regulatory system is under-resourced relative to the speed at which the direct-to-consumer market has grown.⁴ For patients, the practical takeaway is that “available for purchase” is not the same as “FDA approved,” and “no one has stopped them from selling it” is not the same as “it has been tested and found to work.”

Why Hyaluronic Acid Content Complicates the Picture

One argument you sometimes hear from providers is that even if the stem cell count is negligible, the Wharton’s jelly matrix itself is rich in hyaluronic acid and growth factors that benefit joints. This is partially true in a narrow sense. Wharton’s jelly does contain hyaluronic acid, which is the same molecule used in conventional viscosupplementation injections for knee osteoarthritis. Some early case reports have noted improvements in patients who received minimally manipulated Wharton’s jelly formulations that were described as rich in bioactive factors and hyaluronic acid.⁹

But conventional hyaluronic acid injections have been available and FDA cleared for decades, typically at a fraction of the cost. If the benefit of a Wharton’s jelly injection comes from its hyaluronic acid content rather than its stem cells, then you are paying a substantial premium for a product that delivers the same active ingredient as a much cheaper, well-characterized, and properly regulated alternative. The burden of proof is on the Wharton’s jelly product to demonstrate that it offers something above and beyond what hyaluronic acid alone provides, and that proof does not yet exist in any controlled comparison.

What Would FDA Approval Require

For a Wharton’s jelly-derived MSC product to earn FDA approval as a biologic, a company would need to shepherd it through the full development pipeline. That starts with preclinical studies establishing safety and a plausible mechanism, followed by a Phase 1 trial to assess safety in a small number of patients, then a Phase 2 trial to test efficacy and optimize dosing, and finally a Phase 3 trial, typically involving hundreds of patients with a randomized, blinded, placebo-controlled design. The entire process commonly takes a decade or longer and costs hundreds of millions of dollars.

A few companies and academic medical centers are working through early stages of this pathway. The phase 1b graft-versus-host disease trial is one example.⁵ But no Wharton’s jelly MSC product has yet advanced to Phase 3 for any condition in the United States. Until one does, and succeeds, the answer to the title question stays the same: no, these products are not FDA approved, and the timeline for any potential approval remains years away at minimum.