Abstract :
Ex vivo gene therapy in organ transplantation represents a transformative convergence of molecular medicine, transplantation science, and bioethics. By genetically modifying donor organs or recipient immune cells, this approach seeks to reduce ischemia–reperfusion injury, improve graft survival, and mitigate immune rejection. Recent advances in gene editing, particularly the use of CRISPR-Cas9, and the successful development of bioengineered organs for xenotransplantation have brought ex vivo gene therapy to the threshold of first-in-human clinical trials. However, the promise of these technologies is tempered by profound ethical challenges. The lack of comprehensive long-term preclinical data complicates the scientific justification for first-in-human experimentation, creating challenges in determining when clinical trials can responsibly proceed. The question of ‘Informed consent’ becomes invariably complex under conditions of uncertainty, necessitating an iterative, staged approach to communication that explicitly acknowledges both known and unknown risks. Broader questions of justice and equity arise concerning accessibility, affordability, availability, and cultural acceptability, predominantly in contexts where novel costly biotechnologies risk widening disparities in transplantation medicine. Medical ethics traditions ranging from principlism and deontology to communitarian and care ethics offer differing lenses, but no single framework fully addresses the pluralism of values involved in the realm of gene therapy in transplant practice. In conclusion, the integration of gene therapy into transplantation must be guided by transparent oversight, proportional risk–benefit assessment, and respect for participants who assume early research burdens. This perspective article stresses upon the need for sustained dialogue among clinicians, ethicists, regulators, and society to ensure that innovation in transplantation advances not only scientific frontiers but also ethical responsibility.
Keyword :
Bioethics, Gene therapy, Organ transplantation, Transplantation ethics