Infections After Receipt of Bacterially Contaminated Umbilical Cord Blood–Derived Stem Cell Products for Other Than Hematopoietic or Immunologic Reconstitution - United States, 2018

The only Food and Drug Administration (FDA)-approved stem cell products are derived from umbilical cord blood, and their only approved use is hematopoietic and immunologic reconstitution. On Sep 17, 2018, the Texas Department of State Health Services received notification of Enterobacter cloacae and...

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Bibliographic Details
Published inMMWR. Morbidity and Mortality Weekly Report Vol. 67; no. 50; p. 1397
Main Authors Perkins, Kiran M, Spoto, Samantha, Rankin, Danielle A, Dotson, Nychie Q, Malarkey, Mary, Mendoza, Melissa, McNeill, Lorrie, Gable, Paige, Powell, Krista M
Format Report
LanguageEnglish
Published Atlanta U.S. Center for Disease Control 21.12.2018
Subjects
Blood
Blood & organ donations
Citrobacter
Clinics
Cord blood
Disease control
E coli
Enterobacter cloacae
FDA approval
Food contamination & poisoning
Health services
Infections
Laboratories
Patients
Product recalls
Public health
Regulatory agencies
Stem cells
Umbilical cord
United States > US
Texas
California
Florida
Maryland
Virginia
Arizona
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Summary:The only Food and Drug Administration (FDA)-approved stem cell products are derived from umbilical cord blood, and their only approved use is hematopoietic and immunologic reconstitution. On Sep 17, 2018, the Texas Department of State Health Services received notification of Enterobacter cloacae and Citrobacter freundii bloodstream infections in three patients who had received injections or infusions of non-FDA-approved umbilical cord blood-derived stem cell products processed by Genetech, Inc., and distributed by Liveyon, LLC, for other than hematopoietic or immunologic reconstitution at an outpatient clinic on September 12. Patient isolates of E. cloacae had identical pulsed-field gel electropho...resis patterns, suggesting a common source. As of December 14, CDC has received reports of infections in 12 patients from three states, including the initial Florida and Texas cases: Texas (seven), Florida (four), and Arizona .
ISSN:0149-2195
1545-861X