Urgent Need for Regulatory Oversight of Human Cells, Tissues, and Cellular and Tissue–Based Products

摘要: When Shandra Eisenga underwent an elective spine surgery in April 2023, her hope was that it would let her spend more quality time with her grandchildren. A 57-year-old resident of Marion, Michigan, Shandra had already undergone 3 kidney transplants and expected that a spinal fusion procedure would improve her chronic back pain. Yet in the months after her surgery, she developed drainage from her surgical site, lymphadenopathy, night sweats, and 20 lb (9 kg) of unintentional weight loss. In July, she developed septic shock requiring intensive care unit (ICU) admission. At this time, Mycobacterium tuberculosis was identified in her spine andblood. Herclinicalteamwaspuzzled, givenShandra’s lack of any apparent risk factors for tuberculosis. Yet to tuberculosis clinicians, Shandra’s clinical course was immediately—and alarmingly—familiar. In 2021, an outbreak of M tuberculosis occurred in the US when …