Stem cell caution
DEAR DOCTOR: Stem cell therapies are being heavily marketed here in Florida as promising treatments for a variety of illnesses. 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 in two ways. One is news that a patient infected with HIV has been in remission for 18 months following a stem cell transplant. The other news arises from unproven and unapproved stem cell treatments that are being 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. 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. 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 warned about unapproved stem cell treatments. The Food and Drug Administration has issued numerous warnings on the issue.
The allure of stem cells is that they are a 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.
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. Various unapproved stem cell treatments were found to cause harm to patients.
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.