{
 "schema": 1,
 "id": "stem-cell-unproven",
 "type": "procedure",
 "names": {
  "name": "Unapproved stem cell treatment",
  "aliases": [
   "stem cell therapy",
   "regenerative medicine",
   "stromal vascular fraction",
   "SVF",
   "exosome therapy",
   "cell therapy"
  ],
  "said": "The clinic says regenerative medicine and names the tissue the cells came from. The regulator says unapproved and names the disease they were sold for. Neither word describes a mechanism."
 },
 "etymology": {
  "root": "stem cell is a calque of the German Stammzelle — Stamm, a stem, stock or lineage — carried into English from late nineteenth-century embryology, where it meant the cell a line of descendants comes from. Stromal vascular fraction is a processing description, not a diagnosis: what is left of fat tissue after the fat cells are separated out.",
  "tier": "tradition",
  "note": "Autologous means the cells came from the patient; allogeneic means from someone else. Neither word says what the cells do. A product named for its source — umbilical cord, amniotic fluid, Wharton's jelly, adipose tissue — has been named for where it was got, which is the part of the transaction that is verifiable."
 },
 "region": [
  "global",
  "north-america",
  "mexico",
  "central-america"
 ],
 "facets": {
  "family": "unproven",
  "setting": "outpatient-course",
  "anaesthesia": "varies"
 },
 "text": {
  "what": "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.",
  "story": "Two regulators' documents and four studies do most of the work on this page, and none of them is about a faraway country.\n\nThe 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.\n\nThe 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.\n\nThe 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.\n\nThe 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.\n\nThe 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.",
  "how": "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.",
  "today": "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.",
  "notes": "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."
 },
 "metrics": {
  "stay_days": null,
  "days_before_flying": null,
  "recovery_weeks": null,
  "success_rate_pct": null,
  "complication_rate_pct": null,
  "note": "Every number here is null and each is a gap somebody could close. There is no published denominator: no count of patients treated, no register of outcomes, no complication rate. The FDA names blindness, infection and death as risks; the three-patient NEJM series is a demonstration, not an incidence.",
  "as_of": "2026-09-17",
  "source": "s:fda-regenerative-consumer-alert",
  "url": "https://www.fda.gov/vaccines-blood-biologics/consumers-biologics/consumer-alert-regenerative-medicine-products-including-stem-cells-and-exosomes"
 },
 "prices": [
  {
   "procedure": "stem-cell-unproven",
   "country": "PA",
   "city": "Panama City",
   "amount": 15825,
   "amount_high": 26900,
   "currency": "USD",
   "as_of": "2026-09-17",
   "kind": "package",
   "includes": [
    "the injections and the clinic's medical team",
    "customs clearance on arrival at the airport",
    "ground transportation",
    "a stay at a named hotel"
   ],
   "excludes": [
    "flights",
    "anything the page does not name, including any repeat course"
   ],
   "source": "s:cellmedicine-stem-cell-cost",
   "url": "https://www.cellmedicine.com/how-much-does-stem-cell-therapy-cost/",
   "note": "15,825 dollars for a child and 26,900 for an adult, on the clinic's own page. The product is described as umbilical-cord-derived mesenchymal cells under a proprietary name. The page carries no date and makes no statement about regulatory approval.",
   "tier": "cited",
   "usd": 15825.0,
   "usd_high": 26900.0,
   "rate_date": "Wed, 16 Sep 2026"
  },
  {
   "procedure": "stem-cell-unproven",
   "country": "MX",
   "amount": 4950,
   "amount_high": 18000,
   "currency": "USD",
   "as_of": "2026-08",
   "kind": "package",
   "includes": [
    "medical evaluation",
    "laboratory tests and imaging",
    "cell processing with quality testing",
    "the treatment sessions",
    "monitoring and aftercare",
    "accommodation and transfers coordinated by the clinic's concierge"
   ],
   "excludes": [
    "an NK cell cancer programme, priced separately from 50,000 dollars",
    "flights",
    "any dose beyond the one to four vials the plan sets"
   ],
   "source": "s:giostar-mexico-cost",
   "url": "https://giostarmexico.com/stem-cell-therapy-mexico-cost-at-giostar-mexico-global-standards-transparent-pricing-financing-options/",
   "note": "bands by condition group on the clinic's own page, marked verified August 2026: musculoskeletal 6,000-13,000, autoimmune 9,000-14,000, neurological 12,000-18,000, wellness from 4,950. The page cites COFEPRIS certification of the facility, which certifies premises and practice rather than approving a treatment for a disease.",
   "tier": "cited",
   "usd": 4950.0,
   "usd_high": 18000.0,
   "rate_date": "Wed, 16 Sep 2026"
  }
 ],
 "kin": [
  {
   "to": "unproven-stem-cell",
   "as": "What can go wrong, who has measured it, and what the case reports record.",
   "rel": "risk"
  },
  {
   "to": "stem-cell-regulation",
   "as": "Which preparations are lawful to sell where, and on whose approval.",
   "rel": "governed-by"
  },
  {
   "to": "advertising-rules",
   "as": "What a clinic may claim about a product no regulator has approved.",
   "rel": "governed-by"
  },
  {
   "to": "mexico",
   "as": "Where one of the two published price pages sits, and where the border survey counted 76 locations in one city.",
   "rel": "destination"
  },
  {
   "to": "tijuana",
   "as": "The city the one published count of these clinics was made in.",
   "rel": "hub"
  },
  {
   "to": "panama",
   "as": "Where the other published price page sits.",
   "rel": "destination"
  },
  {
   "to": "united-states",
   "as": "The regulator that has enjoined a clinic, and the country the marketing surveys found most of the businesses in.",
   "rel": "destination"
  },
  {
   "to": "deciding-whether",
   "as": "The step where a poor prognosis meets a confident page.",
   "rel": "step"
  },
  {
   "to": "second-opinion",
   "as": "The step at which an unapproved indication is most often identified as one.",
   "rel": "step"
  },
  {
   "to": "malpractice-recourse",
   "as": "A claim about a product no regulator approved, brought against a provider in another country.",
   "rel": "risk"
  },
  {
   "to": "counterfeit-medicines",
   "as": "The mirror case: a product that is not what it says, against a product that is exactly what it says and has not been shown to do anything.",
   "rel": "contrast"
  },
  {
   "to": "car-t",
   "as": "The approved cell therapy, with a licensed indication, a named manufacturer and a price in the same order of magnitude times ten.",
   "rel": "contrast"
  }
 ],
 "confusable_with": [
  {
   "id": "bone-marrow-transplant",
   "tell": "Haematopoietic transplantation is an approved use of blood-forming stem cells for named blood diseases, done in a transplant unit. A clinic offering cells for arthritis or autism is selling something else under the same two words."
  }
 ],
 "links": [
  {
   "label": "FDA consumer alert on regenerative medicine products",
   "url": "https://www.fda.gov/vaccines-blood-biologics/consumers-biologics/consumer-alert-regenerative-medicine-products-including-stem-cells-and-exosomes"
  },
  {
   "label": "FDA statement on the 2019 stem cell clinic permanent injunction",
   "url": "https://www.fda.gov/news-events/press-announcements/statement-stem-cell-clinic-permanent-injunction-and-fdas-ongoing-efforts-protect-patients-risks"
  },
  {
   "label": "Chavez et al., Stem Cell Research & Therapy 2021;12:189",
   "url": "https://pubmed.ncbi.nlm.nih.gov/33736697/"
  }
 ],
 "sources": [
  "s:fda-regenerative-consumer-alert",
  "s:fda-stem-cell-injunction-2019",
  "s:kuriyan-stem-cell-2017",
  "s:turner-knoepfler-2016",
  "s:berger-2016-global-distribution",
  "s:chavez-tijuana-2021",
  "s:cellmedicine-stem-cell-cost",
  "s:giostar-mexico-cost"
 ],
 "provenance": {
  "default": {
   "tier": "cited"
  },
  "fields": {
   "text.story": {
    "tier": "cited",
    "source": "s:fda-regenerative-consumer-alert",
    "note": "every quotation is from the named regulator document or the named paper; no figure here is this project's"
   },
   "text.how": {
    "tier": "cited",
    "source": "s:cellmedicine-stem-cell-cost",
    "note": "both price structures are read off the clinics' own pages; the sentence about what COFEPRIS certification is describes the certification, not the treatment"
   },
   "etymology": {
    "tier": "tradition"
   },
   "prices": {
    "tier": "cited",
    "source": "s:cellmedicine-stem-cell-cost"
   },
   "metrics": {
    "tier": "cited",
    "source": "s:fda-regenerative-consumer-alert"
   }
  }
 },
 "x_commons_files": [
  "File:Mesenchymal stem cell.jpg",
  "File:Human embryonic stem cells.png"
 ],
 "confidence": "high",
 "updated": "2026-09-17",
 "blurb": "A cell preparation is injected, infused or implanted as a treatment for a condition it has not been approved to treat.",
 "region_terms": [
  {
   "key": "global",
   "name": "Everywhere",
   "note": "use for a node that belongs to no one country — a standard, a word, a risk"
  },
  {
   "key": "north-america",
   "name": "North America",
   "note": "the United States and Canada — the two biggest source markets in the world"
  },
  {
   "key": "mexico",
   "name": "Mexico",
   "note": "its own entry because the border towns are a category of their own"
  },
  {
   "key": "central-america",
   "name": "Central America",
   "note": "Costa Rica, Panama, Guatemala, Belize"
  }
 ],
 "kin_out": [
  {
   "to": "unproven-stem-cell",
   "type": "risk",
   "name": "Unproven stem cell treatment",
   "as": "What can go wrong, who has measured it, and what the case reports record.",
   "rel": "risk"
  },
  {
   "to": "stem-cell-regulation",
   "type": "rule",
   "name": "Regulating cell and tissue therapies",
   "as": "Which preparations are lawful to sell where, and on whose approval.",
   "rel": "governed-by"
  },
  {
   "to": "advertising-rules",
   "type": "rule",
   "name": "What a clinic may say",
   "as": "What a clinic may claim about a product no regulator has approved.",
   "rel": "governed-by"
  },
  {
   "to": "mexico",
   "type": "destination",
   "name": "Mexico",
   "as": "Where one of the two published price pages sits, and where the border survey counted 76 locations in one city.",
   "rel": "destination"
  },
  {
   "to": "tijuana",
   "type": "hub",
   "name": "Tijuana",
   "as": "The city the one published count of these clinics was made in.",
   "rel": "hub"
  },
  {
   "to": "panama",
   "type": "destination",
   "name": "Panama",
   "as": "Where the other published price page sits.",
   "rel": "destination"
  },
  {
   "to": "united-states",
   "type": "destination",
   "name": "United States",
   "as": "The regulator that has enjoined a clinic, and the country the marketing surveys found most of the businesses in.",
   "rel": "destination"
  },
  {
   "to": "deciding-whether",
   "type": "pathway",
   "name": "Deciding whether to go",
   "as": "The step where a poor prognosis meets a confident page.",
   "rel": "step"
  },
  {
   "to": "second-opinion",
   "type": "pathway",
   "name": "The second opinion",
   "as": "The step at which an unapproved indication is most often identified as one.",
   "rel": "step"
  },
  {
   "to": "malpractice-recourse",
   "type": "risk",
   "name": "Malpractice recourse across a border",
   "as": "A claim about a product no regulator approved, brought against a provider in another country.",
   "rel": "risk"
  },
  {
   "to": "counterfeit-medicines",
   "type": "risk",
   "name": "Substandard and falsified medicines",
   "as": "The mirror case: a product that is not what it says, against a product that is exactly what it says and has not been shown to do anything.",
   "rel": "contrast"
  },
  {
   "to": "car-t",
   "type": "procedure",
   "name": "CAR T-cell therapy",
   "as": "The approved cell therapy, with a licensed indication, a named manufacturer and a price in the same order of magnitude times ten.",
   "rel": "contrast"
  }
 ],
 "source_list": [
  {
   "id": "s:fda-regenerative-consumer-alert",
   "kind": "org",
   "title": "Consumer Alert on Regenerative Medicine Products Including Stem Cells and Exosomes",
   "publisher": "US Food and Drug Administration",
   "url": "https://www.fda.gov/vaccines-blood-biologics/consumers-biologics/consumer-alert-regenerative-medicine-products-including-stem-cells-and-exosomes",
   "accessed": "2026-09-16"
  },
  {
   "id": "s:fda-stem-cell-injunction-2019",
   "kind": "org",
   "title": "Statement on stem cell clinic permanent injunction and FDA's ongoing efforts to protect patients from risks of unapproved products",
   "publisher": "US Food and Drug Administration",
   "url": "https://www.fda.gov/news-events/press-announcements/statement-stem-cell-clinic-permanent-injunction-and-fdas-ongoing-efforts-protect-patients-risks",
   "accessed": "2026-09-16",
   "note": "25 June 2019; summary judgment of 3 June 2019 in the Southern District of Florida"
  },
  {
   "id": "s:kuriyan-stem-cell-2017",
   "kind": "paper",
   "title": "Vision Loss after Intravitreal Injection of Autologous \"Stem Cells\" for AMD",
   "publisher": "New England Journal of Medicine 2017;376(11):1047-1053 (Kuriyan AE, Albini TA, Townsend JH, et al.)",
   "url": "https://pubmed.ncbi.nlm.nih.gov/28296617/",
   "accessed": "2026-09-16"
  },
  {
   "id": "s:turner-knoepfler-2016",
   "kind": "paper",
   "title": "Selling Stem Cells in the USA: Assessing the Direct-to-Consumer Industry",
   "publisher": "Cell Stem Cell 2016;19(2):154-157 (Turner L, Knoepfler P)",
   "url": "https://pubmed.ncbi.nlm.nih.gov/27374789/",
   "accessed": "2026-09-16"
  },
  {
   "id": "s:berger-2016-global-distribution",
   "kind": "paper",
   "title": "Global Distribution of Businesses Marketing Stem Cell-Based Interventions",
   "publisher": "Cell Stem Cell 19:158-162, 2016; Berger I, Ahmad A, Bansal A, Kapoor T, Sipp D, Rasko JEJ; doi 10.1016/j.stem.2016.07.015",
   "url": "https://europepmc.org/article/MED/27494673",
   "accessed": "2026-09-16"
  },
  {
   "id": "s:chavez-tijuana-2021",
   "kind": "paper",
   "title": "Online marketing practices of regenerative medicine clinics in US-Mexico border region: a web surveillance study",
   "publisher": "Stem Cell Research & Therapy 2021;12(1):189 (Chavez J, Shah NA, Ruoss S, Cuomo RE, Ward SR, Mackey TK); doi 10.1186/s13287-021-02254-4",
   "url": "https://pubmed.ncbi.nlm.nih.gov/33736697/",
   "accessed": "2026-09-17",
   "note": "searches run March to April 2019 in English and Spanish; 110 websites in Tijuana corresponding to 76 confirmed locations; 13 claimed licensing and 1 matched available licensing information"
  },
  {
   "id": "s:cellmedicine-stem-cell-cost",
   "kind": "web",
   "title": "How Much Does Stem Cell Therapy Cost?",
   "publisher": "Stem Cell Institute, Panama City, Panama",
   "url": "https://www.cellmedicine.com/how-much-does-stem-cell-therapy-cost/",
   "accessed": "2026-09-17",
   "note": "the clinic's own page: 15,825 USD for a child and 26,900 USD for an adult, stated to include airport customs clearance, ground transport and a hotel stay. The page names the conditions marketed and makes no statement about regulatory approval."
  },
  {
   "id": "s:giostar-mexico-cost",
   "kind": "web",
   "title": "Stem Cell Therapy Mexico Cost at GIOSTAR Mexico",
   "publisher": "GIOSTAR Mexico",
   "url": "https://giostarmexico.com/stem-cell-therapy-mexico-cost-at-giostar-mexico-global-standards-transparent-pricing-financing-options/",
   "accessed": "2026-09-17",
   "note": "the clinic's own page, marked verified August 2026: packages by condition group, a stated cell count of 35-140 million across 1-4 vials, and a claim of COFEPRIS-certified facilities. No FDA approval is claimed."
  }
 ],
 "tiers": {
  "text.what": {
   "tier": "cited"
  },
  "text.story": {
   "tier": "cited",
   "source": "s:fda-regenerative-consumer-alert",
   "note": "every quotation is from the named regulator document or the named paper; no figure here is this project's"
  },
  "text.how": {
   "tier": "cited",
   "source": "s:cellmedicine-stem-cell-cost",
   "note": "both price structures are read off the clinics' own pages; the sentence about what COFEPRIS certification is describes the certification, not the treatment"
  },
  "text.today": {
   "tier": "cited"
  },
  "etymology": {
   "tier": "tradition"
  },
  "prices": {
   "tier": "cited",
   "source": "s:cellmedicine-stem-cell-cost"
  },
  "metrics": {
   "tier": "cited",
   "source": "s:fda-regenerative-consumer-alert"
  }
 },
 "primary_image": null,
 "tag_facts": [],
 "recognition_facts": [],
 "acclaim": 0,
 "kin_in": [
  {
   "from": "izmir",
   "type": "hub",
   "name": "İzmir",
   "as": "The same evidentiary problem as the thermal indications: a therapeutic claim older or louder than its testing.",
   "rel": "contrast"
  },
  {
   "from": "tijuana",
   "type": "hub",
   "name": "Tijuana",
   "as": "Sold here to patients who cannot buy it at home, which is the whole of its business model.",
   "rel": "performs"
  },
  {
   "from": "unproven-stem-cell",
   "type": "risk",
   "name": "Unproven stem cell treatment",
   "as": "The treatment itself, and what is actually sold under the name.",
   "rel": "procedure"
  },
  {
   "from": "stem-cell-regulation",
   "type": "rule",
   "name": "Regulating cell and tissue therapies",
   "as": "The procedure these instruments are argued over.",
   "rel": "procedure"
  },
  {
   "from": "leigh-turner",
   "type": "person",
   "name": "Leigh Turner",
   "as": "The trade he counted, and the record carrying his 2021 figures.",
   "rel": "procedure"
  }
 ]
}