a procedureUnapproved stem cell treatment

A cell preparation is injected, infused or implanted as a treatment for a condition it has not been approved to treat. The cells come from the patient's own fat or bone marrow, or from donated birth tissue; the delivery is an outpatient appointment or a short course of them; the payment is in advance and in full. The transaction is complete whether or not anything happens afterwards.

Two regulators' documents and four studies do most of the work on this page, and none of them is about a faraway country.

The US Food and Drug Administration states the approval position in one sentence: "Currently, the only stem cell products that are FDA-approved for use in the United States consist of blood-forming stem cells (also known as hematopoietic progenitor cells) that are derived from umbilical cord blood." On the same alert, on exosomes: "There are currently no FDA-approved exosome products." The page then lists what such products are marketed for anyway — arthritis, back pain, multiple sclerosis, Parkinson's, ALS, Alzheimer's, autism, macular degeneration, cardiac and pulmonary disease, chronic pain.

The agency has taken this to court. On 3 June 2019 the US District Court for the Southern District of Florida granted summary judgment against US Stem Cell Clinic LLC of Weston, Florida, US Stem Cell Inc. of Sunrise, and their chief scientific officer Kristin Comella, finding that they had adulterated and misbranded their stromal vascular fraction products; Judge Ursula Ungaro entered a permanent injunction on 25 June. The FDA's statement that day put the risks as "blindness, infection or possibly death" and said the agency had sent 46 manufacturers and health care professionals regulatory correspondences, including warning letters, over the preceding year.

The blindness is not rhetorical. In 2017 the New England Journal of Medicine reported three patients who had adipose-derived cells injected into both eyes for macular degeneration at a US clinic. Their best documented acuity before injection ranged from 20/30 to 20/200. At one year it ranged from 20/200 to no light perception.

The geography is the part most accounts get backwards. Turner and Knoepfler, surveying internet marketing in 2016, wrote that the practice was "a well-known phenomenon in countries with lax medical regulations" and then found "widespread promotion of such interventions by businesses based in the United States". Berger and colleagues, searching globally the same year, found marketing "skewed toward developed economies including the United States, Ireland, Australia, and Germany", with websites making "broad, imprecise therapeutic claims" and frequently failing to detail the procedure.

The border case has been counted once. A 2019 web survey of Tijuana, published in 2021, found 110 websites corresponding to 76 confirmed locations marketing regenerative medicine across the line from San Diego; 99.1% showed no affiliation to an academic institution, 67.3% claimed the tissue was the patient's own, most did not state the route of administration, and of the 13 that claimed licensing, one matched available licensing information.

Priced as a package by condition rather than by dose, paid before treatment, and delivered in a few days. Two clinics publish figures. The Stem Cell Institute in Panama City lists 15,825 US dollars for a child and 26,900 for an adult, stating that airport customs clearance, ground transport and a hotel stay are inside the number; its page names the conditions it markets for and says nothing about approval. GIOSTAR Mexico publishes bands by condition group — 6,000 to 13,000 dollars for musculoskeletal, 12,000 to 18,000 for neurological, 9,000 to 14,000 for autoimmune, from 4,950 for wellness, from 50,000 for an NK cell cancer programme — states a cell count of 35 to 140 million across one to four vials, and cites certification by COFEPRIS, the Mexican health regulator, which is a manufacturing and premises certification rather than an approval of the treatment for a disease.

As of 17 September 2026 no register counts how many people cross a border for an unapproved cell product, what they pay or what becomes of them. What exists is a regulator's list of what is approved, a court record of what has been enjoined, marketplace surveys, and case reports — and the case reports exist because the harm was bad enough to reach a specialist. The two published price pages read for this record are in Panama and Mexico; no US clinic page carrying a published price was read for it.

This page reports what named regulators and published studies say. It is not medical advice, and it makes no claim about any particular clinic beyond what that clinic publishes about itself.