Investigation of Bacterial Infections Among Patients Treated With Umbilical Cord Blood–Derived Products Marketed as Stem Cell Therapies
| Autor: | Janice J. Kim, Erin Breaker, Lorrie McNeill, Hollis Houston, Melissa Mendoza, Kathleen P. Hartnett, Erin Epson, Nychie Dotson, Paige Gable, Alison Laufer Halpin, Robert Hunter, Valerie A. Stevens, Kiran M. Perkins, Krista M. Powell, Mary Malarkey, Samantha Spoto, Gillian McAllister, Danielle A. Rankin |
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| Jazyk: | angličtina |
| Rok vydání: | 2021 |
| Předmět: |
Adult
Male medicine.medical_specialty Adolescent medicine.medical_treatment Blood Safety Vial Umbilical cord Disease Outbreaks Young Adult Internal medicine Outcome Assessment Health Care medicine Humans Public Health Surveillance Young adult Child Original Investigation Aged Aged 80 and over Marketing business.industry United States Food and Drug Administration Medical record Research General Medicine Stem-cell therapy Bacterial Infections Middle Aged medicine.disease United States Online Only medicine.anatomical_structure Infectious Diseases Rheumatoid arthritis Cord blood Child Preschool Female Cord Blood Stem Cell Transplantation Stem cell Centers for Disease Control and Prevention U.S business |
| Zdroj: | JAMA Network Open |
| ISSN: | 2574-3805 |
| Popis: | Key Points Question Were infections in patients who received umbilical cord blood products marketed as stem cell treatment associated with product contamination? Findings In this case series, 20 patients in 8 states developed bacterial infections after receiving unapproved products marketed as treatment for conditions including chronic pain and degenerative joint conditions. This national investigation found widespread bacterial contamination of undistributed and distributed products from multiple donors, with whole-genome sequencing indicating a common source. Meaning The findings from this outbreak underscore that unapproved and unproven stem cell products can expose patients to serious risks without clear benefit, including the possibility of product contamination. This case series examines bacterial infections in 20 patients who received umbilical cord blood–derived products marketed as stem cell treatment. Importance The number of clinics marketing stem cell products for joint diseases, chronic pain, and most recently, COVID-19, has increased despite warnings from the US Food and Drug Administration that stem cell products for these and other indications have not been proven safe or effective. Objective To examine bacterial infections in 20 patients who received umbilical cord blood–derived products marketed as stem cell treatment. Design, Setting, and Participants This case series is a national public health investigation including case-finding, medical record review and abstraction, and laboratory investigation, including sterility testing of products and whole-genome sequencing of patient and product isolates. Participants included patients who developed bacterial infections following administration of umbilical cord blood–derived products marketed as stem cell treatment during August 2017 to September 2018. Data analysis was performed from March 2019 to September 2021. Exposures Umbilical cord blood–derived products marketed as stem cell treatment. Main Outcomes and Measures Data were collected on patient infections and exposures. The Centers for Disease Control and Prevention performed sterility testing on undistributed and distributed vials of product marketed as stem cell treatment and performed whole-genome sequencing to compare patient and product bacterial isolates. Results Culture-confirmed bacterial infections were identified in 20 patients (median [range] age, 63 [2-89] years; 13 male patients [65%]) from 8 US states who sought stem cell treatment for conditions including pain, osteoarthritis, rheumatoid arthritis, and injury; all but 1 required hospitalization. The most frequently isolated bacteria from patients with infections were common enteric species, including Escherichia coli (14 patients) and Enterobacter cloacae (7 patients). Of unopened, undistributed products sampled for testing, 65% (22 of 34 vials) were contaminated with at least 1 of 16 bacterial species, mostly enteric. A patient isolate from Arizona matched isolates obtained from products administered to patients in Florida, and patient isolates from Texas matched undistributed product sent from the company in California. Conclusions and Relevance Unapproved stem cell products can expose patients to serious risks without proven benefit. Sequencing results suggest a common source of extensive contamination, likely occurring during the processing of cord blood into product. Patients and health care practitioners who are considering the use of unapproved products marketed as stem cell treatment should be aware of their unproven benefits and potential risks, including serious infections. |
| Databáze: | OpenAIRE |
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