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Clinics at home and abroad sell stem cell infusions and injections to people finishing cancer treatment. The FDA has recorded blindness, tumour formation and infections from these products, and says plainly that if you are being charged for one outside a clinical trial you are likely being deceived. Two of the harms are written up in the New England Journal of Medicine.
The industry is large and domestic, not only foreign. A 2016 survey of internet marketing identified widespread promotion of unapproved stem cell interventions by businesses based in the United States, and a follow-up found that a cohort of 570 clinics had changed substantially within three years while the total number grew. Treatments are sold for fatigue, immune recovery, neuropathy, 'anti-ageing' and, at the worst end, for the cancer itself.
The FDA's consumer page states that unapproved products marketed as regenerative medicine, whether taken from the person's own body or someone else's, include stem cells, stromal vascular fraction, umbilical cord blood, amniotic fluid, Wharton's jelly, ortho-biologics and exosomes, and that it "has received reports of blindness, tumor formation, infections, and more" from their use. It adds: "if you are being charged for these products or offered these products outside of a clinical trial, you are likely being deceived and offered a product illegally", and warns that registration of a study on clinicaltrials.gov is often presented as if it were FDA approval, which it is not.
Two case reports show what the harms look like. Three women with age-related macular degeneration lost vision after intravitreal injection of autologous adipose-derived cells at a clinic; the report is in the New England Journal of Medicine. A man who had received intrathecal injections of mesenchymal, embryonic and fetal neural stem cells at clinics in China, Argentina and Mexico developed a glioproliferative lesion of the spinal cord, also reported in the New England Journal of Medicine. In the UK, a cell therapy is an advanced therapy medicinal product and the MHRA requires a marketing authorisation for anything placed on the market; the hospital exemption is narrow and still needs a manufacturer's licence.
There is one setting in which stem cells are standard cancer care, and it is the transplant ward: autologous and allogeneic haematopoietic transplant, done in a licensed centre, for a defined indication. That is not what a clinic is selling.
There is no mechanism to state, because the products are not characterised: source tissue, cell type, dose, viability and sterility differ between clinics and are usually not disclosed. The harms reported follow from that, and from injecting live cells into compartments such as the eye and the spinal canal where they can proliferate or scar.
Query for this technology: (TITLE:"stem cell tourism" OR ABSTRACT:"stem cell tourism" OR TITLE:"unproven stem cell" OR ABSTRACT:"unproven stem cell" OR TITLE:"direct-to-consumer stem cell" OR ABSTRACT:"direct-to-consumer stem cell"). Results are unfiltered search hits about Stem cell clinics and stem cell tourism, not a curated reading list.
Shares Alternative medicine used instead of standard treatment, What actually works after treatment, Survivorship and late effects are neglected and the tags rejuvenation, survivorship, unproven, regulator-warning.
Shares Alternative medicine used instead of standard treatment, What actually works after treatment, Survivorship and late effects are neglected and the tags rejuvenation, survivorship, unproven, regulator-warning.
Shares Alternative medicine used instead of standard treatment, What actually works after treatment, Late effects and survivorship toxicity, Survivorship and late effects are neglected and the tags rejuvenation, survivorship, unproven.
Shares Alternative medicine used instead of standard treatment, What actually works after treatment, Survivorship and late effects are neglected and the tags rejuvenation, survivorship, unproven.
Shares What actually works after treatment, Autologous stem cell transplant (high-dose therapy), Allogeneic stem cell transplantation, Late effects and survivorship toxicity and the tags rejuvenation, survivorship.
Shares What actually works after treatment, Late effects and survivorship toxicity, Survivorship and late effects are neglected and the tags rejuvenation, survivorship.
Shares What actually works after treatment, Late effects and survivorship toxicity, Survivorship and late effects are neglected and the tags rejuvenation, survivorship.
Shares What actually works after treatment, Late effects and survivorship toxicity, Survivorship and late effects are neglected and the tags rejuvenation, survivorship.