FDA Issues Warning Over Risks Associated with Stem Cell Treatments After A Dozen Patients Contract Bacterial Infections
Health officials in the United States warned, last week, of an outbreak of bacterial infections related to injections of stem cells derived from umbilical cord blood. So far, at least a dozen patients have been reported in Arizona, Florida, and Texas have become infected after receiving stem cell injections which were intended to back pain, degenerative joint disease, and a rotator cuff tear, according to the US Centers for Disease Control and Prevention. All 12 of the noted patients were hospitalized, though three stayed for a month or longer. Fortunately, no deaths have been reported.
Investigators do not believe the contamination of these stem cells occurred at the clinics where these shots were administered. They believe this because they found bacteria in unopened vials at the distributor, Liveyon. The Yorba Linda, the CA-based company voluntarily recalled the stem cells tested, in October.
Last month, however, the United States Food and Drug Administration delivered a warning to Genetech Inc. This is a small San Diego-based company who processed the stem cells. The warning issued by the FDA instructed the company that they should not be marketing these stem cells to customers without approval from regulators. The warning also dictates that Genetech has diverted from its original manufacturing requirements in ways which might be the reason for the bacterial contamination.
Stem cells are very young cells that can develop into specialized cells within the body. Scientist use stem cells to manufacture biological blood cells, bone cells, and brain cells; and we are currently studying them to determine if they have the potential to become disease treatments. As a matter of fact, some stem cell treatments have already been approved for quite a few medical procedures. Actually, hundreds of private clinics have opened over the past few years, specifically promoting the use of stem cells to treat disease.
Unfortunately, despite the promising results laboratory testing has found, there is not much evidence that they are effective or safe. Indeed, the CDC report discussing these cases comment, “This investigation highlights the serious potential risks to patients of stem cell therapies administered for unapproved and unproven uses.