Bozkurt, B. et al. Heart failure epidemiology and outcomes statistics: a report of the Heart Failure Society of America. J. Card. Fail. 29, 1412–1451 (2023).Article PubMed PubMed Central Google Scholar Fedeli, U. et al. Mortality from chronic liver disease: recent trends and impact of the COVID-19 pandemic. World J. Gastroenterol. 29, 4166–4173 (2023).Article PubMed PubMed Central Google Scholar World Health Organization. Chronic obstructive pulmonary disease (COPD); https://www.who.int/news-room/fact-sheets/detail/chronic-obstructive-pulmonary-disease-(copd) (2024).Kovesdy, C. P. Epidemiology of chronic kidney disease: an update 2022. Kidney Int. Suppl. 12, 7–11 (2022).Article Google Scholar Rana, A. et al. Survival benefit of solid-organ transplant in the United States. JAMA Surg. 150, 252–259 (2015).Article PubMed Google Scholar Statista. Estimated number of organ transplantations worldwide in 2023; https://www.statista.com/statistics/398645/global-estimation-of-organ-transplantations/ (2024).Eurotransplant. Eurotransplant Annual Report 2023; https://www.eurotransplant.org/wp-content/uploads/2024/06/ETP_AR2023_LowRes.pdf (2024).Chesnaye, N. C., Ortiz, A., Zoccali, C., Stel, V. S. & Jager, K. J. The impact of population ageing on the burden of chronic kidney disease. Nat. Rev. Nephrol. 20, 569–585 (2024).Article PubMed Google Scholar Guha, A. et al. Implication of ventricular assist devices in extracorporeal membranous oxygenation patients listed for heart transplantation. J. Clin. Med. 8, 572 (2019).Article CAS PubMed PubMed Central Google Scholar Pockros, B. M., Finch, D. J. & Weiner, D. E. Dialysis and total health care costs in the United States and worldwide: the financial impact of a single-payer dominant system in the US. J. Am. Soc. Nephrol. 32, 2137–2139 (2021).Article PubMed PubMed Central Google Scholar Chadban, S. et al. Projecting the economic burden of chronic kidney disease at the patient level (inside CKD): a microsimulation modelling study. EClinicalMedicine 72, 102615 (2024).Article PubMed PubMed Central Google Scholar Wang, Y. et al. Pig-to-human kidney xenotransplants using genetically modified minipigs. Cell Rep. Med. 5, 101744 (2024).Article CAS PubMed PubMed Central Google Scholar Mehta, M., Hosgood, S. & Nicholson, M. L. Protocol for a single-centre randomised pilot study to assess the safety and feasibility of adding a CytoSorb filter during kidney normothermic machine perfusion to remove inflammatory and immune mediators prior to kidney transplantation. BMJ Open 15, e093001 (2025).Article PubMed PubMed Central Google Scholar Hosgood, S. A. et al. Normothermic machine perfusion versus static cold storage in donation after circulatory death kidney transplantation: a randomized controlled trial. Nat. Med. 29, 1511–1519 (2023).Article CAS PubMed PubMed Central Google Scholar Schlegel, A. et al. A multicenter randomized-controlled trial of hypothermic oxygenated perfusion (HOPE) for human liver grafts before transplantation. J. Hepatol. 78, 783–793 (2023).Article CAS PubMed Google Scholar Ardehali, A. et al. Ex-vivo perfusion of donor hearts for human heart transplantation (PROCEED II): a prospective, open-label, multicentre, randomised non-inferiority trial. Lancet 385, 2577–2584 (2015).Article PubMed Google Scholar Schroder, J. N. et al. Increasing utilization of extended criteria donor hearts for transplantation. JACC Heart Fail. 12, 438–447 (2024).Article CAS PubMed Google Scholar Loupy, A., Mengel, M. & Haas, M. Thirty years of the International Banff Classification for Allograft Pathology: the past, present, and future of kidney transplant diagnostics. Kidney Int. 101, 678–691 (2022).Article PubMed Google Scholar Cozzi, E., Colpo, A. & De Silvestro, G. The mechanisms of rejection in solid organ transplantation. Transfus. Apher. Sci. 56, 498–505 (2017).Article PubMed Google Scholar De Graav, G. N. et al. New developments and therapeutic drug monitoring options in costimulatory blockade in solid organ transplantation: a systematic critical review. Ther. Drug Monit. 47, 64–76 (2025).Article PubMed Google Scholar Fodor Duric, L., Basic Jukic, N. & Vujicic, B. Comparison of autologous and allogeneic adipose-derived stem cells in kidney transplantation: immunological considerations and therapeutic efficacy. J. Clin. Med. 13, 5763 (2024).Article CAS PubMed PubMed Central Google Scholar Zhang, W. et al. Patch grafting, strategies for transplantation of organoids into solid organs such as liver. Biomaterials 277, 121067 (2021).Article CAS PubMed PubMed Central Google Scholar Mohiuddin, M. M. et al. Graft dysfunction in compassionate use of genetically engineered pig-to-human cardiac xenotransplantation: a case report. Lancet 402, 397–410 (2023).Article PubMed PubMed Central Google Scholar Anand, R. P. et al. Design and testing of a humanized porcine donor for xenotransplantation. Nature 622, 393–401 (2023).Article CAS PubMed PubMed Central Google Scholar Poirier, N. et al. Inducing CTLA-4–dependent immune regulation by selective CD28 blockade promotes regulatory T cells in organ transplantation. Sci. Transl. Med. 2, 17ra10 (2010).Article PubMed PubMed Central Google Scholar Loupy, A. et al. Prediction system for risk of allograft loss in patients receiving kidney transplants: international derivation and validation study. BMJ 366, l4923 (2019).Article PubMed PubMed Central Google Scholar Zhang, X., Gavaldà, R. & Baixeries, J. Interpretable prediction of mortality in liver transplant recipients based on machine learning. Comput. Biol. Med. 151, 106188 (2022).Article PubMed Google Scholar Bartosh, T. J. et al. Aggregation of human mesenchymal stromal cells (MSCs) into 3D spheroids enhances their antiinflammatory properties. Proc. Natl Acad. Sci. USA 107, 13724–13729 (2010).Article CAS PubMed PubMed Central Google Scholar Sablik, M. et al. Microvascular inflammation of kidney allografts and clinical outcomes. N. Engl. J. Med. 392, 763–776 (2025).Article CAS PubMed Google Scholar Khush, K. K. et al. The international thoracic organ transplant registry of the international society for heart and lung transplantation: thirty-sixth adult heart transplantation report — 2019; focus theme: donor and recipient size match. J. Heart Lung Transplant. 38, 1056–1066 (2019).Article PubMed PubMed Central Google Scholar Halverson, L. P. & Hachem, R. R. Antibody-mediated rejection. Clin. Chest Med. 44, 95–103 (2023).Article PubMed PubMed Central Google Scholar Van Der Mark, S. C., Hoek, R. A. S. & Hellemons, M. E. Developments in lung transplantation over the past decade. Eur. Respir. Rev. 29, 190132 (2020).Article PubMed PubMed Central Google Scholar Choudhary, N. S. et al. Acute and chronic rejection after liver transplantation: what a clinician needs to know. J. Clin. Exp. Hepatol. 7, 358–366 (2017).Article PubMed PubMed Central Google Scholar Manzia, T. M. et al. Immunosuppression in adult liver transplant recipients: a 2024 update from the italian liver transplant working group. Hepatol. Int. 18, 1416–1430 (2024).Article PubMed Google Scholar Lucey, M. R., Furuya, K. N. & Foley, D. P. Liver transplantation. N. Engl. J. Med. 389, 1888–1900 (2023).Article CAS PubMed Google Scholar Fernando, J. J., Biswas, R. & Biswas, L. Non‐invasive molecular biomarkers for monitoring solid organ transplantation: a comprehensive overview. Int. J. Immunogenet. 51, 47–62 (2024).Article CAS PubMed Google Scholar Millán, O., Julian, J. & Brunet, M. miRNAs, dd-cf-DNA, and chemokines as potential noninvasive biomarkers for the assessment of clinical graft evolution and personalized immunosuppression requirement in solid organ transplantation. Ther. Drug Monit. 47, 77–97 (2025).Article PubMed Google Scholar Madill-Thomsen, K. S. & Halloran, P. F. Precision diagnostics in transplanted organs using microarray-assessed gene expression: concepts and technical methods of the molecular microscope diagnostic system (MMDx). Clin. Sci. 138, 663–685 (2024).Article CAS Google Scholar Halloran, P. F. Immunosuppressive drugs for kidney transplantation. N. Engl. J. Med. 351, 2715–2729 (2004).Article CAS PubMed Google Scholar Ufere, N. N., Satapathy, N., Philpotts, L., Lai, J. C. & Serper, M. Financial burden in adults with chronic liver disease: a scoping review. Liver Transpl. 28, 1920–1935 (2022).Article PubMed PubMed Central Google Scholar Jha, V. et al. Global economic burden associated with chronic kidney disease: a pragmatic review of medical costs for the inside CKD research programme. Adv. Ther. 40, 4405–4420 (2023).Article PubMed PubMed Central Google Scholar Al Moussawy, M., Lakkis, Z. S., Ansari, Z. A., Cherukuri, A. R. & Abou-Daya, K. I. The transformative potential of artificial intelligence in solid organ transplantation. Front. Transplant. 3, 1361491 (2024).Article PubMed PubMed Central Google Scholar Kamath, P. S. & Kim, W. R. The model for end-stage liver disease (MELD). Hepatology 45, 797–805 (2007).Article PubMed Google Scholar Bertsimas, D. et al. Development and validation of an optimized prediction of mortality for candidates awaiting liver transplantation. Am. J. Transplant. 19, 1109–1118 (2019).Article PubMed Google Scholar Brüggenwirth, I. M. A. et al. The liver retransplantation risk score: a prognostic model for survival after adult liver retransplantation. Transpl. Int. 34, 1928–1937 (2021).Article PubMed Google Scholar Truchot, A. et al. Extended validations of the iBox system in real life settings. In 22nd Congress of the European Society for Organ Transplantation Abstract FOS_06_1 (ESOT, 2025).Klein, A. et al. Qualifying a novel clinical trial endpoint (iBOX) predictive of long-term kidney transplant outcomes. Am. J. Transplant. 23, 1496–1506 (2023).Article CAS PubMed Google Scholar Raynaud, M. et al. Dynamic prediction of renal survival among deeply phenotyped kidney transplant recipients using artificial intelligence: an observational, international, multicohort study. Lancet Digit. Health 3, e795–e805 (2021).Article CAS PubMed Google Scholar Loupy, A. et al. Identification and characterization of trajectories of cardiac allograft vasculopathy after heart transplantation: a population-based study. Circulation 141, 1954–1967 (2020).Article PubMed Google Scholar Loftus, T. J. et al. Artificial intelligence-enabled decision support in nephrology. Nat. Rev. Nephrol. 18, 452–465 (2022).Article PubMed PubMed Central Google Scholar Monlezun, D. J., Samura, A. T., Patel, R. S., Thannoun, T. E. & Balan, P. Racial and socioeconomic disparities in out-of-hospital cardiac arrest outcomes: artificial intelligence-augmented propensity score and geospatial cohort analysis of 3,952 patients. Cardiol. Res. Pract. 2021, 3180987 (2021).Article PubMed PubMed Central Google Scholar Becker, J. U. et al. Artificial intelligence and machine learning in nephropathology. Kidney Int. 98, 65–75 (2020).Article CAS PubMed PubMed Central Google Scholar Peyster, E. et al. Computational pathology assessments of cardiac stromal remodeling: clinical correlates and prognostic implications in heart transplantation. JHLT Open 7, 100202 (2024).Yoo, D. et al. An automated histological classification system for precision diagnostics of kidney allografts. Nat. Med. 29, 1211–1220 (2023).Article CAS PubMed Google Scholar Demir, Z. et al. Identification of liver transplant biopsy phenotypes associated with distinct liver biological markers and allograft survival. Am. J. Transplant. 24, 954–966 (2024).Article CAS PubMed Google Scholar Zielinski, D. et al. Molecular diagnosis of kidney allograft rejection based on the Banff Human Organ Transplant (B-HOT) gene panel: a multicenter international study. Am. J. Transplant. https://doi.org/10.1016/j.ajt.2025.04.025 (2025).Spooner, A. et al. Benchmarking ensemble machine learning algorithms for multi-class, multi-omics data integration in clinical outcome prediction. Brief. Bioinform. 26, bbaf116 (2025).Article PubMed PubMed Central Google Scholar Khanal, B. et al. Investigating the robustness of vision transformers against label noise in medical image classification. Ann. Int. Conf. IEEE Eng. Med. Biol. Soc. 2024, 1–6 (2024).Tasca, P. et al. Application of spatial-omics to the classification of kidney biopsy samples in transplantation. Nat. Rev. Nephrol. 20, 755–766 (2024).Article PubMed Google Scholar Amancherla, K. et al. Dynamic responses to rejection in the transplanted human heart revealed through spatial transcriptomics. Preprint at bioRxiv https://doi.org/10.1101/2025.02.28.640852 (2025).Kang, M. et al. Spatial transcriptomic signatures of early acute T cell–mediated rejection in kidney transplants. Transplant. Direct 10, e1705 (2024).Article PubMed PubMed Central Google Scholar Martin-Martin, C. et al. Exploring kidney allograft rejection: a proof-of-concept study using spatial transcriptomics. Am. J. Transplant. 24, 1161–1171 (2024).Article PubMed Google Scholar Mou, L. et al. Single-cell genomics and spatial transcriptomics in islet transplantation for diabetes treatment: advancing towards personalized therapies. Front. Immunol. 16, 1554876 (2025).Article CAS PubMed PubMed Central Google Scholar Chauveau, B., Couzi, L. & Merville, P. The microscope and beyond: current trends in the characterization of kidney allograft rejection from tissue samples. Transplantation 109, 440–453 (2025).Article PubMed Google Scholar Cross, A. R., Gartner, L., Hester, J. & Issa, F. Opportunities for high-plex spatial transcriptomics in solid organ transplantation. Transplantation 107, 2464–2472 (2023).Article PubMed Google Scholar Noel, T., Wang, Q. S., Greka, A. & Marshall, J. L. Principles of spatial transcriptomics analysis: a practical walk-through in kidney tissue. Front. Physiol. 12, 809346 (2022).Article PubMed PubMed Central Google Scholar Pilch, N. A., Bowman, L. J. & Taber, D. J. Immunosuppression trends in solid organ transplantation: the future of individualization, monitoring, and management. Pharmacotherapy 41, 119–131 (2021).Article PubMed Google Scholar Dunn, D. L. Problems related to immunosuppression. Infection and malignancy occurring after solid organ transplantation. Crit. Care Clin. 6, 955–977 (1990).Article CAS PubMed Google Scholar Kasiske, B. L. Payment for immunosuppression after organ transplantation. JAMA 283, 2445–2450 (2000).Article PubMed Google Scholar Aubert, O. et al. Cell-free DNA for the detection of kidney allograft rejection. Nat. Med. 30, 2320–2327 (2024).Article CAS PubMed PubMed Central Google Scholar Van Rijn, A., Roos, R., Dekker, F., Rotmans, J. & Feltkamp, M. Torque teno virus load as marker of rejection and infection in solid organ transplantation – a systematic review and meta-analysis. Rev. Med. Virol. 33, e2393 (2023).Article PubMed Google Scholar Thishya, K., Vattam, K. K., Naushad, S. M., Raju, S. B. & Kutala, V. K. Artificial neural network model for predicting the bioavailability of tacrolimus in patients with renal transplantation. PLoS ONE 13, e0191921 (2018).Article PubMed PubMed Central Google Scholar Süsal, C. & Döhler, B. Late intra-patient tacrolimus trough level variability as a major problem in kidney transplantation: a collaborative transplant study report. Am. J. Transplant. 19, 2805–2813 (2019).Article PubMed Google Scholar Wang, Z. et al. Locally controlled release of immunosuppressive promotes survival of transplanted adult spinal cord tissue. Regen. Biomater. 10, rbac097 (2023).Article CAS PubMed Google Scholar Chang, C. -C. et al. A peptide derived from interleukin-10 exhibits potential anticancer activity and can facilitate cell targeting of gold nanoparticles loaded with anticancer therapeutics. Commun. Chem. 6, 278 (2023).Article CAS PubMed PubMed Central Google Scholar Cassano, A., Chong, A. S. & Alegre, M. -L. Tregs in transplantation tolerance: role and therapeutic potential. Front. Transplant. 2, 1217065 (2023).Article PubMed PubMed Central Google Scholar Bézie, S., Anegon, I. & Guillonneau, C. Advances on CD8+ Treg cells and their potential in transplantation. Transplantation 102, 1467–1478 (2018).Article PubMed Google Scholar Sawitzki, B. et al. Regulatory cell therapy in kidney transplantation (The ONE Study): a harmonised design and analysis of seven non-randomised, single-arm, phase 1/2A trials. Lancet 395, 1627–1639 (2020).Article CAS PubMed PubMed Central Google Scholar Proics, E. et al. Preclinical assessment of antigen-specific chimeric antigen receptor regulatory T cells for use in solid organ transplantation. Gene Ther. 30, 309–322 (2023).Article CAS PubMed Google Scholar European Cooperation in Science and Technology (COST). BM1305 - action to focus and accelerate cell-based tolerance-inducing therapies (A FACTT); https://www.cost.eu/actions/BM1305/ (2018).European Cooperation in Science and Technology. COST Action Mye-EUNITER establish a common yet robust protocol for the comparative analysis of myeloid cells (MDSC) in various diseases; https://www.cost.eu/breaking-boundaries-cost-action-mye-euniter/ (2020).INsTRuCT Consortium. A network of European scientists from academic and industry focused on developing innovative myeloid regulatory cell (MRC)-based immunotherapies; https://instruct-h2020.eu/consortium (2020).Pushpakom, S. et al. Drug repurposing: progress, challenges and recommendations. Nat. Rev. Drug Discov. 18, 41–58 (2019).Article CAS PubMed Google Scholar Corsello, S. M. et al. Discovering the anticancer potential of non-oncology drugs by systematic viability profiling. Nat. Cancer 1, 235–248 (2020).Article CAS PubMed PubMed Central Google Scholar Zhang, Q. et al. Drug repurposing: ibrutinib exhibits immunosuppressive potential in organ transplantation. Int. J. Med. Sci. 15, 1118–1128 (2018).Article CAS PubMed PubMed Central Google Scholar Zhou, Y. et al. Network-based drug repurposing for novel coronavirus 2019-nCoV/SARS-CoV-2. Cell Discov. 6, 14 (2020).Article CAS PubMed PubMed Central Google Scholar Laubenbacher, R. et al. Building digital twins of the human immune system: toward a roadmap. NPJ Digit. Med. 5, 64 (2022).Article CAS PubMed PubMed Central Google Scholar Montgomery, R. A. et al. Results of two cases of pig-to-human kidney xenotransplantation. N. Engl. J. Med. 386, 1889–1898 (2022).Article CAS PubMed Google Scholar Porrett, P. M. et al. First clinical-grade porcine kidney xenotransplant using a human decedent model. Am. J. Transplant. 22, 1037–1053 (2022).Article PubMed Google Scholar Locke, J. E., Kumar, V., Anderson, D. & Porrett, P. M. Normal graft function after pig-to-human kidney xenotransplant. JAMA Surg. 158, 1106–1108 (2023).Article PubMed PubMed Central Google Scholar NYU Langone Health. wo-month study of pig kidney xenotransplantation gives new hope to the future of the organ supply; https://nyulangone.org/news/two-month-study-pig-kidney-xenotransplantation-gives-new-hope-future-organ-supply (2023).Kawai, T. et al. Xenotransplantation of a porcine kidney for end-stage kidney disease. N. Engl. J. Med. 392, 1933–1940 (2025).NYU Langone Health. First-ever combined heart pump and pig kidney transplant gives new hope to patient with terminal illness; https://nyulangone.org/news/first-ever-combined-heart-pump-gene-edited-pig-kidney-transplant-gives-new-hope-patient-terminal-illness (2024).NYU Langone Health. Gene-edited pig kidney gives living donor new lease on life; https://nyulangone.org/news/gene-edited-pig-kidney-gives-living-donor-new-lease-life (2024).Griffith, B. P. et al. Genetically modified porcine-to-human cardiac xenotransplantation. N. Engl. J. Med. 387, 35–44 (2022).Article CAS PubMed PubMed Central Google Scholar Tao, K. -S. et al. Gene-modified pig-to-human liver xenotransplantation. Nature 641, 1029–1036 (2025).Mallapaty, S. First pig-to-human liver transplant recipient ‘doing very well’. Nature 630, 18–18 (2024).Article CAS PubMed Google Scholar US Food & Drug Administration. Xenotransplantation; https://www.fda.gov/vaccines-blood-biologics/xenotransplantation (2021).Cooper, D. K. C. & Cozzi, E. Clinical pig heart xenotransplantation—where do we go from here? Transpl. Int. 37, 12592 (2024).Article PubMed PubMed Central Google Scholar Griffith, B. P. et al. Transplantation of a genetically modified porcine heart into a live human. Nat. Med. 31, 589–598 (2025).Article CAS PubMed Google Scholar Moazami, N. et al. Pig-to-human heart xenotransplantation in two recently deceased human recipients. Nat. Med. 29, 1989–1997 (2023).Article CAS PubMed Google Scholar Kotz, D. In Memoriam: Lawrence Faucette. University of Maryland School of Medicine. https://www.medschool.umaryland.edu/news/2023/in-memoriam-lawrence-faucette.html (2023).Eisenson, D. L., Hisadome, Y. & Yamada, K. Progress in xenotransplantation: immunologic barriers, advances in gene editing, and successful tolerance induction strategies in pig-to-primate transplantation. Front. Immunol. 13, 899657 (2022).Article CAS PubMed PubMed Central Google Scholar Cross-Najafi, A. A. et al. Current barriers to clinical liver xenotransplantation. Front. Immunol. 13, 827535 (2022).Article CAS PubMed PubMed Central Google Scholar Zhang, X. et al. A review of pig liver xenotransplantation: current problems and recent progress. Xenotransplantation 26, e12497 (2019).Article PubMed PubMed Central Google Scholar Loupy, A. et al. Immune response after pig-to-human kidney xenotransplantation: a multimodal phenotyping study. Lancet 402, 1158–1169 (2023).Article CAS PubMed Google Scholar Samy, K. P., Butler, J. R., Li, P., Cooper, D. K. C. & Ekser, B. The role of costimulation blockade in solid organ and islet xenotransplantation. J. Immunol. Res. 2017, 1–11 (2017).Article Google Scholar Dominici, M. et al. Minimal criteria for defining multipotent mesenchymal stromal cells. The international society for cellular therapy position statement. Cytotherapy 8, 315–317 (2006).Article CAS PubMed Google Scholar Thomson, J. A. et al. Embryonic stem cell lines derived from human blastocysts. Science 282, 1145–1147 (1998).Article CAS PubMed Google Scholar Hyun, I. The bioethics of stem cell research and therapy. J. Clin. Invest. 120, 71–75 (2010).Article CAS PubMed PubMed Central Google Scholar Yamanaka, S. Induced pluripotent stem cells: past, present, and future. Cell Stem Cell 10, 678–684 (2012).Article CAS PubMed Google Scholar Wnorowski, A., Yang, H. & Wu, J. C. Progress, obstacles, and limitations in the use of stem cells in organ-on-a-chip models. Adv. Drug Deliv. Rev. 140, 3–11 (2019).Article CAS PubMed Google Scholar Wang, S. et al. Transplantation of chemically induced pluripotent stem-cell-derived islets under abdominal anterior rectus sheath in a type 1 diabetes patient. Cell 187, 6152–6164 (2024).Article CAS PubMed Google Scholar Guilak, F. et al. Control of stem cell fate by physical interactions with the extracellular matrix. Cell Stem Cell 5, 17–26 (2009).Article CAS PubMed PubMed Central Google Scholar Zhao, Z. et al. Organoids. Nat. Rev. Methods Primers 2, 94 (2022).Article CAS PubMed PubMed Central Google Scholar McKee, C. & Chaudhry, G. R. Advances and challenges in stem cell culture. Colloids Surf. B Biointerfaces 159, 62–77 (2017).Article CAS PubMed Google Scholar Dzobo, K. et al. Advances in regenerative medicine and tissue engineering: innovation and transformation of medicine. Stem Cells Int. 2018, 2495848 (2018).Article PubMed PubMed Central Google Scholar Shopova, D. et al. (Bio)printing in personalized medicine-opportunities and potential benefits. Bioengineering 10, 287 (2023).Article PubMed PubMed Central Google Scholar Li, P. et al. The potential role of 3D-bioprinting in xenotransplantation. Curr. Opin. Organ Transplant. 24, 547–554 (2019).Article CAS PubMed PubMed Central Google Scholar Murphy, S. V. & Atala, A. 3D bioprinting of tissues and organs. Nat. Biotechnol. 32, 773–785 (2014).Article CAS PubMed Google Scholar Vanaei, S., Parizi, M. S., Vanaei, S., Salemizadehparizi, F. & Vanaei, H. R. An overview on materials and techniques in 3D bioprinting toward biomedical application. Eng. Regen. 2, 1–18 (2021).Google Scholar Ricci, G., Gibelli, F. & Sirignano, A. Three-dimensional bioprinting of human organs and tissues: bioethical and medico-legal implications examined through a scoping review. Bioengineering 10, 1052 (2023).Article PubMed PubMed Central Google Scholar Pipis, N., James, B. D. & Allen, J. B. Multifunctional DNA-collagen biomaterials: developmental advances and biomedical applications. ACS Biomater. Sci. Eng. 11, 1253–1268 (2025).Article CAS PubMed PubMed Central Google Scholar Rodrigues, F. A. P. et al. Molecules in motion: unravelling the dynamics of vascularization control in tissue engineering. Macromol. Biosci. 24, 2400139 (2024).Article CAS Google Scholar Neishabouri, A., Soltani Khaboushan, A., Daghigh, F., Kajbafzadeh, A. -M. & Majidi Zolbin, M. Decellularization in tissue engineering and regenerative medicine: evaluation, modification, and application methods. Front. Bioeng. Biotechnol. 10, 805299 (2022).Article PubMed PubMed Central Google Scholar Rathnam, C. et al. Hybrid SMART spheroids to enhance stem cell therapy for CNS injuries. Sci. Adv. 7, eabj2281 (2021).Article CAS PubMed PubMed Central Google Scholar Torabinavid, P., Khosropanah, M. H., Azimzadeh, A. & Kajbafzadeh, A. -M. Current strategies on kidney regeneration using tissue engineering approaches: a systematic review. BMC Nephrol. 26, 66 (2025).Article PubMed PubMed Central Google Scholar Abbaszadeh, S. et al. Emerging strategies to bypass transplant rejection via biomaterial-assisted immunoengineering: insights from islets and beyond. Adv. Drug Deliv. Rev. 200, 115050 (2023).Article CAS PubMed Google Scholar Ajima, K. et al. A porcine islet-encapsulation device that enables long-term discordant xenotransplantation in immunocompetent diabetic mice. Cell Rep. Methods 3, 100370 (2023).Article CAS PubMed Google Scholar Keymeulen, B. et al. Encapsulated stem cell–derived β cells exert glucose control in patients with type 1 diabetes. Nat. Biotechnol. 42, 1507–1514 (2024).Article CAS PubMed Google Scholar Zhang, K. et al. Concepts and applications of digital twins in healthcare and medicine. Patterns 5, 101028 (2024).Article PubMed PubMed Central Google Scholar Keyue, X. & Qiongfang, D. China’s first AI hospital town debuts: revolutionizing healthcare with artificial intelligence (Global Times, 2024).Hein, D. et al. Prompts to table: specification and iterative refinement for clinical information extraction with large language models. Preprint at medRxiv https://doi.org/10.1101/2025.02.11.25322107 (2025).Liu, X. et al. A generalist medical language model for disease diagnosis assistance. Nat. Med. 31, 932–942 (2025).Article CAS PubMed Google Scholar Tozuka, R. et al. Application of NotebookLM, a large language model with retrieval-augmented generation, for lung cancer staging. Jpn. J. Radiol. 43, 706–712 (2024).Singh, R. et al. ChatGPT vs. Gemini: comparative accuracy and efficiency in lung-RADS score assignment from radiology reports. Clin. Imaging 121, 110455 (2025).Article PubMed Google Scholar Villani, V., Nguyen, H. -H. T. & Shanmugarajah, K. Evaluating quality and readability of AI-generated information on living kidney donation. Transplant. Direct 11, e1740 (2024).Article PubMed PubMed Central Google Scholar Demirbaş, K. C. et al. The potential of ChatGPT as a source of information for kidney transplant recipients and their caregivers. Pediatr. Transplant. 29, e70068 (2025).Article PubMed Google Scholar Temsah, A. et al. DeepSeek in healthcare: revealing opportunities and steering challenges of a new open-source artificial intelligence frontier. Cureus 17, e79221 (2025).PubMed PubMed Central Google Scholar Bedi, S. et al. Testing and evaluation of health care applications of large language models: a systematic review. JAMA 333, 319–328 (2025).Article PubMed Google Scholar Miao, J., Thongprayoon, C., Craici, I. M. & Cheungpasitporn, W. How to improve ChatGPT performance for nephrologists: a technique guide. J. Nephrol. 37, 1397–1403 (2024).Article PubMed Google Scholar Horgan, S., Vanuno, D., Sileri, P., Cicalese, L. & Benedetti, E. Robotic-assisted laparoscopic donor nephrectomy for kidney transplantation. Transplantation 73, 1474–1479 (2002).Article PubMed Google Scholar Giulianotti, P. C. et al. Robot-assisted right lobe donor hepatectomy. Transpl. Int. 25, e5–e9 (2012).Article PubMed Google Scholar Boggi, U. et al. Laparoscopic robot-assisted pancreas transplantation: first world experience. Transplantation 93, 201–206 (2012).Article PubMed Google Scholar Emerson, D., Catarino, P., Rampolla, R., Chikwe, J. & Megna, D. Robotic-assisted lung transplantation: first in man. J. Heart Lung Transplant. 43, 158–161 (2024).Article PubMed Google Scholar Lu, Y., Zhou, Y., Ju, R. & Chen, J. Human-animal chimeras for autologous organ transplantation: technological advances and future perspectives. Ann. Transl. Med. 7, 576 (2019).Article CAS PubMed PubMed Central Google Scholar Tan, T. et al. Chimeric contribution of human extended pluripotent stem cells to monkey embryos ex vivo. Cell 184, 3589 (2021).Article CAS PubMed Google Scholar Lebret, A. Allocating organs through algorithms and equitable access to transplantation—a European human rights law approach. J. Law Biosci. 10, lsad004 (2023).US Food and Drug Administration. Current Good Manufacturing Practice regulations for drugs (21 CFR Parts 210 & 211) (2023).US Food and Drug Administration. Expedited programs for regenerative medicine therapies for serious conditions—guidance for industry (2019).US Food and Drug Administration. CBER standards recognition program for regenerative medicine therapies standard recognition summary (SRS) (2023).European Commission. Regulation (EC) no. 1394/2007 of the European parliament and of the council of 13 November 2007 on advanced therapy medicinal products and amending directive 2001/83/EC and regulation (EC) no. 726/2004—EU requirements for ATMP authorization and hospital exemption (2007).Zhang, J. et al. Standardisation is the key to the sustained, rapid and healthy development of stem cell-based therapy. Clin. Transl. Med. 14, e1646 (2024).Article CAS PubMed PubMed Central Google Scholar World Health Organization. WHO releases AI ethics and governance guidance for large multi-modal models (2024).European Commission. Proposal for a Regulation on the European Health Data Space (2022).US Food and Drug Administration. Artificial intelligence and machine learning in software as a medical device (2025).Wang, W., He, W., Ruan, Y. & Geng, Q. First pig-to-human heart transplantation. Innovation 3, 100223 (2022).PubMed PubMed Central Google Scholar Cooper, D. K. C. et al. Regulation of clinical xenotransplantation—time for a reappraisal. Transplantation 101, 1766–1769 (2017).Article PubMed PubMed Central Google Scholar Hawthorne, W. J. et al. Third WHO Global Consultation on Regulatory Requirements for Xenotransplantation Clinical Trials, Changsha, Hunan, China December 12–14, 2018: ‘The 2018 Changsha Communique’ The 10-year anniversary of The International Consultation on Xenotransplantation. Xenotransplantation 26, e12513 (2019).Centers for Disease Control and Prevention. Morbidity and Mortality Weekly Report. US Public Health Service Guideline on infectious disease issues in xenotransplantation. MMWR Recomm. Rep. 50, 1–46 (2001).US Department of Health and Human Services Food and Drug Administration Center for Biologics Evaluation and Research. Source animal, product, preclinical, and clinical issues concerning the use of xenotransplantation products in humans–guidance for industry (2016).Hawthorne, W. J., Cowan, P. J., Buhler, L. & Wolf, E. International standards and guidelines for xenotransplantation. Nat. Biotechnol. 39, 1501–1502 (2021).Article CAS PubMed Google Scholar Fishman, J. A., Scobie, L. & Takeuchi, Y. Xenotransplantation‐associated infectious risk: a WHO consultation. Xenotransplantation 19, 72–81 (2012).Article PubMed PubMed Central Google Scholar World Health Organization. First WHO global consultation on regulatory requirements for xenotransplantation clinical trials: Changsha, China, 19–21 November 2008. The Changsha Communiqué. Xenotransplantation 16, 61–63 (2009).Harris, A. R., Walker, M. J. & Gilbert, F. Ethical and regulatory issues of stem cell-derived 3-dimensional organoid and tissue therapy for personalised regenerative medicine. BMC Med. 20, 499 (2022).Article PubMed PubMed Central Google Scholar Witten, C. M., McFarland, R. D. & Simek, S. L. Concise review: the US food and drug administration and regenerative medicine. Stem Cells Transl. Med. 4, 1495–1499 (2015).Article PubMed PubMed Central Google Scholar US Food and Drug Administration. Regulatory considerations for human cells, tissues, and cellular and tissue-based products: minimal manipulation and homologous use. FDA-2017-D-6146 (2020).