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Unproven Stem Cell Treatments Blind 3 Women (npr.org)
An anonymous reader quotes a report from NPR: Scientists have long hoped that stem cells might have the power to treat diseases. But it's always been clear that they could be dangerous too, especially if they're not used carefully. Now a pair of papers published Wednesday in the New England Journal of Medicine is underscoring both the promise and the peril of using stem cells for therapy. In one report, researchers document the cases of three elderly women who were blinded after getting stem cells derived from fat tissue at a for-profit clinic in Florida. The treatment was marketed as a treatment for macular degeneration, the most common cause of blindness among the elderly. Each woman got cells injected into both eyes. In a second report, a patient suffering from the same condition had a halt in the inexorable loss of vision patients usually experience, which may or may not have been related to the treatment. That patient got a different kind of stem cell derived from skin cells as part of a carefully designed Japanese study. The Japanese case marks the first time anyone has given induced pluripotent stem (iPS) cells to a patient to treat any condition. The report about the three women in their 70s and 80s who were blinded in Florida is renewing calls for the Food and Drug Administration to crack down on the hundreds of clinics that are selling unproven stem cell treatments for a wide variety of medical conditions, including arthritis, autism and stroke.
Many US states have "right to try" laws, and this is the sort of thing that those laws are designed to allow.
On the supply side you have charlatans, well meaning doctors who have a dud treatment they truly believe in, and well meaning doctors who have a working-but-unproven treatment they truly believe in. On the demand side, you have patients who want to pay for a miracle and have bought into the (often hard-sell and deceptive) sales story of the supply side. These combine to try to push politicians into allowing unproven medical treatments. The medical establishment objects, but are often drowned out.
You can find lots of criticism of "right to try" here.
Quattuor res in hoc mundo sanctae sunt: libri, liberi, libertas et liberalitas.
They didn't use mesenchymal, they used indued pluripotent stem cells derived from fat cells.. There's different ways cells can be induced to pluripotency (the Yamanaka method is the favorite) but the one of the biggest trouble with iPSCs is their epigenetic profiles [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3760008/]. Basically just because you activate the genes you need for iPSCs to form doesn't mean their epigenetic profiles are the same as naturually occuring pluripotent cells, so unexpected growth and differentiation can occur. Also, iPSCs have a tendency to become cancerous, so even if you run the same treatment there's still a risk of tumor formation.
Injecting ANYTHING into somebody's Eye is dangerous business.
Sure, but these women had macular degeneration and were going blind anyway. MD causes the vision to deteriorate first in the center of the visual field, and then expand outward, so the most important part of sight is lost first, leaving only peripheral vision. So it's not like 3 women with perfect vision suddenly lost their sight.
Well looks like I clicked on the wrong NEJM abstract in the link, you were right, they did use adipose derived stem cells. But the entire thing is much, much worse than iPSCs. First, the method they used wasn't the same one in clinical trials. But secondly, the patients thought they were receiving the clinical trial procedure (which they weren't) AND the procedure they thought they were getting had already been revoked from clinical trials by the time they got this shady one. From the paper: "A distinction has been made between clinical studies of stem-cell therapies that are founded on solid preclinical research with strong scientific design and programs that lack preclinical research justification. These programs are often funded by patients at nonacademic centers, and they may not receive FDA oversight if these procedures are performed without the filing of an investigational new drug application with the FDA, which requires extensive safety data. At least one of the patients thought the procedure was performed within the context of a clinical trial (NCT02024269). However, the consent forms signed by all three patients do not mention a clinical trial. The patients paid for a procedure that had never been studied in a clinical trial, lacked sufficient safety data, and was performed in both eyes on the same day."