On the 3rd, United Therapeutics, a US biotechnology company, announced that it has completed the first clinical trial surgery of transplanting gene edited pig kidneys into humans at New York University Langone Medical Center, marking the official launch of the large-scale clinical trial of this surgery.
According to US media reports, this is the first large-scale clinical trial approved by the US Food and Drug Administration (FDA) for human transplantation of gene edited pig kidneys, following multiple previous cases of “compassion drug” transplantation surgeries. The aim is to systematically evaluate the safety and efficacy of gene edited pig kidneys for end-stage kidney disease patients.
At the initial stage of the research plan, 6 subjects were enrolled and underwent surgery at two transplantation centers. At least 12 weeks after the completion of the first batch of surgeries, an independent data monitoring committee will review safety and efficacy data to determine whether to proceed with the next phase of the study, which may involve expanding to approximately 50 participants in the future.
According to the research protocol, the subjects were aged between 55 and 70 years old, diagnosed with end-stage renal disease, and had undergone hemodialysis for at least 6 months. After receiving gene edited pig kidney transplantation, the subjects will undergo a 24 week follow-up to evaluate indicators such as kidney function, survival rate, quality of life, and safety, and receive long-term monitoring to assess organ function and potential animal source infection risk.
The joint therapy company stated in a statement that the gene edited pig kidney developed by the company has undergone 10 gene edits, knocking out 4 genes that may cause human rejection, and adding 6 human genes to improve the compatibility between animal organs and the human immune system.
Robert Montgomery, the head of the transplant surgery team and director of the Langone Transplantation Institute at New York University, said that this clinical study is a key turning point in transplant medicine, providing a new path for alleviating global organ shortages through xenotransplantation technology.
Pig organs are similar in tissue structure and physiological function to human organs, making pigs an ideal donor candidate for xenotransplantation. However, xenotransplantation faces various risks and technical challenges. In recent years, the US medical team has conducted individual transplant trials under the FDA’s “compassionate drug” framework. In January of this year, Brigham Medical Center at Massachusetts General Hospital completed a gene edited pig kidney transplant surgery. After the surgery, the pig kidney maintained its function in the human body for nearly 9 months, setting a new record for similar trials and laying the foundation for subsequent clinical research.
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