Contextual Vulnerability Should Guide Fair Subject Selection in Xenotransplantation Clinical Trials by Gianna Strand

“…This potential subject population includes individuals with broadly reactive antibodies who are unlikely to match to a donor organ and individuals with anatomical contraindications who face prohibitive risks with standard allografts or bridging therapies.[xl] This subject population aligns with the FDA recommendation to enroll subjects for whom safe and effective alternatives are not available.…”
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