When human "parts" can be manufactured: How far has organ replacement technology come?

According to the latest report released in 2024 by the WHO Global Observatory on Donation and Transplantation (GODT), about 173,000 solid organ transplants were performed worldwide in the year, marking a historic high. However, in the same year, official waiting lists in 75 countries still had 668,000 patients queuing, including 378,000 waiting for kidneys. 31,800 patients died while waiting, with more than 60% awaiting kidneys. The above data is from GODT’s 2024 annual report. It only covers patients registered on official lists. Many terminal patients in middle- and low-income countries have no chance of being counted. The actual gap is much greater. The room for optimizing the donation system is limited, while demand keeps expanding with aging. The supply of organs cannot match the demand, and improving allocation efficiency alone is not enough. An increasingly prominent approach is: directly manufacturing organs. Immortal Dragons is a longevity-tech fund established in Singapore, managing about $40 million, with investments in over 20 longevity startups, covering xenotransplantation, 3D bioprinting, gene therapy, and more. In a recent conversation with Wall Street Insights, founder Boyang explained the fund’s core investment theme—“Replacement Strategy”: replacing degenerated or diseased components with brand new organs, tissues, or parts, rather than patching up native tissues. Boyang said, “Most responses to diseases are still patchwork, trading patient quality of life and financial burden for limited extension of life. We believe replacing and solving the shortage of human ‘parts’ is a more pragmatic direction than combating complex pathologies.” This judgment is supported by data. According to Mayo Clinic, among 1,500+ major common human diseases, more than 700 have no known cure. For terminal organ failure patients, replacing with a functioning organ is much better than maintaining a declining one. The problem is: what to use for manufacturing, and how to keep the manufactured organ alive. Both paths converge on one answer: vascularization. Any tissue block over 100–200 microns thick, lacking a perfusable vascular network inside, will see its cells suffer oxygen deprivation and die. This is a physical constraint, unrelated to engineering expertise. All tissue engineering projects, whether printing vessels or growing a heart, ultimately hit this wall. In June 2025, Stanford published a study in Science, developing an algorithm platform that designs organ-level vascular tree structures at 230 times previous speeds, successfully maintaining thick-layer cell survival in 3D printing tests. The team has generated enough human stem cells to print a complete heart, and is now combining cells and vasculature. This is a key signal: the challenge of vascularization is shifting from “known as difficult” to “precisely defined where the difficulty lies,” and is starting to see systematic engineering solutions. But from algorithm design to a clinically usable complete organ, there remains a series of verifications, including manufacturing, immune tolerance, and long-term functional stability. 01 Milestone Year for Two Routes Against this background, both technological routes delivered milestone data in 2025. In xenotransplantation, in August 2025, the team led by He Jianxing at the First Affiliated Hospital of Guangzhou Medical University completed the world’s first gene-edited pig lung transplant into a brain-dead human; the transplanted lung maintained gas exchange for 9 days, without hyperacute rejection. This achievement was published in Nature Medicine and selected as one of 12 global biomedical breakthroughs of 2025. In the US, Mass General Brigham’s pig kidney transplant patient Tim Andrews survived with the pig kidney for 271 days before removal due to chronic rejection, setting a world record. In January this year, Andrews successfully received a human kidney transplant, becoming the first to complete the full bridge from pig kidney to human kidney. In 3D bioprinting, besides Stanford’s algorithmic breakthrough for vascularization, Chinese teams are advancing rapidly as well. In August 2025, a Shanghai lab cultivated the world’s first live heart organoid exceeding 1 cm in diameter. In December of the same year, the team led by Xie Maobin at Guangzhou Medical University developed a “second-level” bio 3D printer, with post-printing cell survival rates over 95% after 14 days. CalTech developed an in-body ultrasound printing technology, allowing in-situ manufacturing of implants deep within the body. Both routes have pros and cons, but jointly point to one direction: organ replacement is moving from proof-of-concept to engineering stage. 02 The Logic of Starting with Blood Vessels At the intersection of the two routes, some companies are taking a pragmatic entry point: starting with vascularization itself. Frontier Bio, based in the San Francisco Bay Area, focuses on small diameter vascular grafts. Traditional synthetic vessels fail at diameters smaller than 5 mm, mainly because they lack natural endothelial layers, leading to thrombosis and intimal hyperplasia. Surgeons currently substitute by harvesting the patient’s own veins for bypass, which adds surgery time and is limited by available donor vessels. Frontier Bio’s solution bypasses the biggest bottleneck of traditional tissue-engineered blood vessels: ex vivo culture cycles. At surgery, a small tissue sample is taken from the patient’s abdominal subcutaneous fat; a mechanical oscillation device bed-side separates adipose-derived stem cells; these are immediately seeded onto degradable polymer scaffolds made by electrospinning, all done on the operating table, with the graft implanted on the spot. No ex vivo culture, no allogeneic cells. Large animal experiments showed that 14 days post-implant of pig carotid artery grafts, immunofluorescence confirmed a continuous CD31-positive endothelial layer on the lumen, and orderly integration of smooth muscle cells. The graft is converting into a living blood vessel in vivo. Currently the only FDA-approved tissue-engineered blood vessel is Humacyte’s Symvess (approved in 2024 for trauma indications), which relies on weeks of ex vivo culture plus decellularization. Frontier Bio retains living autologous cells, adopting the “minimal manipulation” regulatory pathway, avoiding high approval thresholds for allogeneic cells. Immortal Dragons, investor in Frontier Bio, shares two reasons for choosing blood vessels as the entry point: “Vascularization is the common bottleneck in all tissue engineering. Entry through structurally simpler, urgently needed blood vessels enables near-term clinical data and revenue. More crucially, it validates whether the paradigm of bedside on-demand manufacturing of living tissue can be extended to more complex organs.” Frontier Bio’s main product line targets the $12 billion global vascular replacement market, but the path from large animal data to FDA clinical registration and market is long and capital-intensive. The real stabilizer is the second product line: using the same tissue manufacturing capability to develop in vitro models, including microfluidic blood-brain barrier organ-on-a-chip and 3D-bioprinted mini-lungs, aimed at pharmaceutical preclinical testing. Organ chips do not involve implantation, have low approval hurdles, and pharmaceutical repurchase cycles are stable, generating revenue during clinical advancement of the main product line. 03 Regulatory Breakthrough & Unresolved Technical Risks Regulatory environments are accelerating collaboration. In China, in January 2026, the National Healthcare Security Administration officially established pricing items for bio 3D printing (tissue/vessel/organ) auxiliary fees, opening channels for clinical translation billing. Effective May 1, 2026, the State Council issued the "Regulations for Clinical Research and Translation of New Biomedical Technologies," which covers technologies acting on cellular and molecular levels—stem cells, gene editing, iPSC, etc.—putting them within the National Health Commission’s unified filing and review framework, with priority channels for urgently needed technologies. In the US, the FDA Modernization Act 2.0 (passed in 2022) removed the mandatory animal testing requirement; in 2025, new evaluation methods (NAMs) further expanded, for the first time accepting organ chip data to support IND applications. Frontier Bio’s BBB model and mini-lung now have a real regulatory entry window. But biotechnology risks cannot be ignored. Vascularization has direction, but capillary-level (<10 microns) anastomosis cannot be directly manufactured by any printing method; the final step must rely on in vivo native vessel growth, which is still uncontrollable in speed and scope. Chronic rejection and thrombotic microvasculopathy remain the main modes of failure after xenotransplantation, and the 271-day human data did not surpass predictive limits from non-human primate models. Frontier Bio’s autologous cell approach naturally avoids acute immune rejection, but the 14-day large animal data only covers the acute phase; chronic host–graft interface immune reactions remain uncharted. Between the 668,000 on waiting lists and blood vessel scaffolds growing an endothelial layer after 14 days in the lab stands not a single barrier, but a long chain of engineering validation. But in 2025, every link in that chain saw quantifiable progress. Organ replacement technologies are moving beyond proof-of-concept. Risk Disclosure and Disclaimer Markets involve risk; investment requires caution. This article does not constitute individual investment advice, nor does it account for users’ particular investment goals, financial status or needs. 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