Dear Doctor: Stem cell therapies are being heavily marketed here in Florida as promising treatments for a variety of illnesses, but I have my doubts. As a retired doctor, I hate to see people go into debt to pay for something fraudulent or unsafe. Am I being too critical?
Dear Reader: Stem cell therapies are making headlines right now in two very different ways. One is the news that a patient infected with HIV has been in remission for 18 months following a stem cell transplant. The other stem cell news arises from the subject of your letter. That is, unproven and unapproved stem cell treatments. These are being widely marketed as miracle cures for everything from Parkinson’s disease, autism, arthritis and dementia to depression, multiple sclerosis, macular degeneration and traumatic brain injury.
Although the use of embryonic stem cells is federally monitored, adult stem cells can be extracted from a patient’s own body. That makes regulation and oversight challenging.
Despite extravagant claims of success by stem cell clinics, outcomes are largely unproven. However, the potential dangers are clear. In the past year, at least 17 people in five states have become gravely ill following stem cell treatments that used injections of umbilical cord blood and required hospitalization. In one such case, a man who received an injection of umbilical cord blood to address joint pain developed sepsis, a life-threatening infection. He spent 58 days in the hospital.
Last December, the Centers for Disease Control and Prevention published a report warning about unapproved stem cell treatments. The Food and Drug Administration has issued numerous warnings on the issue as well.
The allure of stem cells is that they are a kind of blank canvas. These “unprogrammed” cells divide rapidly and have the ability to change into other types of cells, such as bone, brain or muscle cells. As a result, stem cells are the centerpiece of regenerative medicine, in which disease and injury are treated by growing new cells, or by replacing or repairing those that are dead and damaged.
Thanks to their unique properties, stem cells are seen as important tools in potential new therapies for diabetes, Parkinson’s and heart disease, among others. But because stem cells are undifferentiated, they must first go through a special process, somewhat like programming, in which they are prepared to become specific types of cells. It is during this process, as well as during the act of transplantation, that potential risks to patients can arise.
According to the CDC, a number of vials of stem cell products made from umbilical cord blood were found to be contaminated with E. coli. Even before this latest spate of bad news, various unapproved stem cell treatments were found to cause harm to patients that included severe respiratory illness, blindness and even death.
With few consumer protections in place at this time, the FDA recommends that patients avoid stem cell therapies that are not part of an approved clinical trial. To find ongoing and upcoming clinical trials that use stem cells, visit clinicaltrials.gov. The home page contains a form that you can use to focus your search.
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