A single patient with end-stage kidney disease received a gene-edited porcine kidney (EGEN-2784; eGenesis) under costimulation blockade with complement inhibition, followed by human kidney allotransplantation 82 days after xenograft removal — the first reported living recipient in a 3-patient FDA Expanded Access study.
The xenograft sustained dialysis independence for 271 days; early T-cell-mediated rejection (day 14) resolved with treatment, but late microvascular inflammation progressing to thrombotic microangiopathy caused graft failure after immunosuppression reduction. No zoonotic pathogen transmission occurred, anti-HLA antibodies were unchanged, and subsequent human allotransplantation (day 82 post-explant) showed immediate function with no sensitisation over 231 days of follow-up.
- Single patient (n=1); conclusions about durability, rejection mechanisms, and safety cannot be generalised. - Causal role of reduced immunosuppression vs. intrinsic xenograft biology in late TMA cannot be separated. - Longer follow-up of the allotransplant kidney needed to fully exclude delayed sensitisation effects.
Porcine kidney xenotransplantation can bridge patients with long expected wait times to human allotransplantation without causing clinically significant allosensitisation or zoonotic infection. Clinicians should be aware that late graft injury may involve macrophage/NK-cell-mediated microvascular mechanisms not captured by standard donor-specific crossmatch monitoring.
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