基因编辑猪肾，人体移植有新突破

Core Viewpoint - United Therapeutics has initiated the first clinical trial of gene-edited pig kidney transplantation in humans, marking a significant step towards large-scale clinical trials in this field [1][2]. Group 1: Clinical Trial Details - The trial is the first FDA-approved human transplantation of gene-edited pig kidneys, aimed at systematically evaluating the safety and efficacy for patients with end-stage renal disease [2]. - The initial phase will recruit 6 patients, with an independent data monitoring committee reviewing safety and efficacy data after at least 12 weeks post-surgery [2]. - If successful, the trial may expand to include up to 50 participants as more transplant centers join [2]. Group 2: Background and Significance - Previous cases of pig kidney transplantation were conducted under "compassionate use" rules for critically ill patients, but this trial allows for a more stable patient population [3]. - The trial represents a transition from individual cases to systematic clinical research, indicating technological maturity and a new phase in gene-edited organ transplantation [3]. - Another company, eGenesis, plans to start its own pig kidney clinical trial within months, aiming to complete 33 trials over the next two and a half years [3]. Group 3: Current Status and Challenges - As of early November, at least two patients (one in China and one in the U.S.) who received gene-edited pig kidney transplants are still alive [4]. - A notable case in China has seen a transplanted pig kidney functioning well for over 240 days, potentially setting a record for survival [5]. - The field of xenotransplantation aims to address the shortage of human organ donations, but challenges remain, including immune rejection and ensuring long-term organ viability [6][7].