Eight Texas patients developed bacterial infections soon after receiving an umbilical cord blood-derived stem cell product from mid-2017 through September of 2018, state health officials said in an advisory.
The cases have been identified as part of a nationwide investigation of bacterial infections occurring after a procedure involving the injection of a stem cell product manufactured by Genetech Inc. and distributed by Liveyon LLC. Specifically, the product is from Genetech’s ReGen Series, officials said.
Bloodstream and joint infections as well as epidural abscesses have been reported. “Symptoms of the infections include pain, fever, chills, and swelling at injection site,” according to an advisory from the Texas Department of State Health Services (DSHS).
Furthermore, a 2018 U.S. Food and Drug Administration (FDA) inspection found that Genetech was not appropriately testing and screening umbilical cord blood donors for communicable diseases such as HIV, hepatitis B, and hepatitis C, the DSHS advisory said.
“The transmission risk of HIV, hepatitis B, and hepatitis C through stem cell products is very low, and no reports of these diseases have been linked to the ReGen Series product,” the advisory said.
However, Texas physicians are encouraged to conduct a full medical assessment – including for HIV, hepatitis B and hepatitis C – of patients who received ReGen Series stem cell products from 2017 to September 2018.
Find more information on the Centers for Disease Control and Prevention’s website.
Last Updated On
May 08, 2019