12 Hospitalized with Bacterial Infections from Stem Cell Injections
Twelve patients have suffered serious illnesses after getting injections, which contained stem cells from umbilical cord blood, the New York Times reports. The U.S. Food and Drug Administration (FDA) issued a warning to California-based Genetech, the company that made the blood products these patients were given. The patients who became ill had been given injections to their knees, shoulders or spines to treat painful conditions such as arthritis.
They contracted infections in their bloodstreams or joints and all had to be hospitalized. Patients ended up spending several days in the hospital and tests of unopened vials of the cord-blood products taken from the clinics giving these shots found the same types of pathogens that had infected the patients including E. coli and other fecal bacteria.
Enforcement of Safety Standards
The FDA said it had also written to 20 other clinics that offer unapproved stem cell treatments warning them that such products are generally regulated by the agency. Enforcement of these products is expected to tighten before November 2020. FDA Commissioner Scott Gottlieb said the agency would be going in and inspecting more stem cell operators this year. The FDA, he said, would focus on outfits that may be engaging in unsafe practices and haven’t been working with the agency to comply with federal safety laws. He also said there are too many firms that are not in compliance.
Hundreds of these clinics have sprouted around the country offering treatments purportedly containing stem cells claiming to treat a wide variety of ailments including arthritis, eye disorders, Parkinson’s disease and lung problems. These treatments are marketed as having healing properties. However, there is no scientific proof that they are safe or effective. Clinics that offer these treatments claim they are not drugs and that therefore, they don’t require FDA approval. But, the agency has disagreed with that assumption.
In November 2017, the FDA gave these clinics three years to come into compliance. In May 2018, the FDA sought permanent injunctions against two stem cell clinics including one in Florida that treated three patients who lost their sight after stem cells were injected into their eyes. Another clinic in Southern California had been administering a combination of smallpox vaccine and stem cells to cancer patients.
Consumers Should Be Cautious
These illnesses are yet another example of why consumers should be extremely cautious when approaching alternative or unorthodox treatments, even if they are not for serious or life-threatening illnesses. Treatments that are not FDA-approved or inspected may not be safe or effective. Since they are not inspected on a routine basis, any such contamination might go undetected putting patients at risk of serious infections.
If you or a loved one has been sickened as a result of these defective products, please contact an experienced California product defect lawyer who will fight to protect your rights and help you secure fair compensation for your losses.