Non-FDA Approved Use of Stem Cell Products Linked to Dangerous Infections
As of Dec. 14, 2018, the Food & Drug Administration (FDA) has gotten 12 reports of patients from Texas, Florida, and Arizona, who acquired infections after receiving Genetech stem cell injection or infusions.
Today, the only approved stem cell products are derived from umbilical cord blood, and the only approved use for them is to increase the number of blood cells or to increase the body’s immune capacity. If unapproved stem cell therapies are administered, or if they are administered for reasons other than to increase the body’s blood or immune systems, patients can face a number of unknown health complications. Even so companies continue to manufacture and market stem cell-based products for the treatment of other conditions, such as chronic pain and orthopedic conditions, without FDA approval.
Twelve patients have been reported to the FDA as having developed serious infections after receiving infusions or injections of stem-cell products processed by Genetech and distributed by Liveyon. The infections consisted of bloodstream infections, joint infections, and epidural abscesses. Each of the twelve patients was hospitalized because of their infection. Several unopened vials of the Genetech umbilical stem cells have been tested and found to contain bacteria that can result in infection, or possibly death.
The FDA recommends that individuals avoid receiving these products outside of controlled clinical studies to ensure that safety reporting procedures are being followed and to minimize the risk of acquiring dangerous infections.
The attorneys at D’Arcy Johnson Day are actively investigating infections caused by stem cell injections.
If you or a loved one has acquired an infection after receiving a non-FDA approved stem cell infusion or injection, contact the attorneys at D’Arcy Johnson Day for a free and confidential evaluation of your case. You can submit a free legal consultation form online, call the office at (609) 641-6200, or request more information at firstname.lastname@example.org.
Dr. Graziani joined D’Arcy Johnson Day in 2013, bringing her medical expertise and legal education to advocate for the firm’s clients. Since joining D’Arcy Johnson Day, she has successfully advocated for clients with a wide range of catastrophic personal injuries and medical malpractice claims.