Dr. Tsung-Dao Lee, the 'Father of Serum,' at 90, Launches Regenerative Medicine Initiative to Empower Asia's Aging Population

He became an immunogeneticist, earned a Ph.D. in Immunology in the United States, and was hailed as the “Father of Serology.” He emerged as a renowned expert in bone marrow transplantation matching and stem cell clinical laboratory science, serving as Professor at the University of Washington, Director of the HLA Laboratory at the American National Red Cross Research Institute, Chairman of the First World Histocompatibility Conference organized by the International Federation of Red Cross and Red Crescent Societies, and Director of the Tzu Chi Bone Marrow Donor Registry Center. In 1992, he returned to China, dedicating himself to establishing a bone marrow registry for individuals of Chinese descent.

The above appears to be a summary of the first half of Dr. Tsung-Dao Lee’s life, which has been widely celebrated.

Underpinning these experiences is the rapid advancement of immunology and regenerative medicine during the second half of the 20th century. Since the late 19th century, when Russian zoology professor Metchnikoff observed the initial steps of the inflammatory response in injured starfish, our understanding of immunology has undergone rapid iteration over the course of a century. The theoretical framework of immunology has gradually expanded and matured, further extending its frontiers with the advent of systematic research into stem cell technologies, thereby opening new avenues for treating previously incurable diseases and patients.

Adhering to the belief that “medicine embodies an indisputable universal spirit—human life is paramount, and all are equal in the face of life,” Li Zhengdao has witnessed various transformations across the ocean: stem cell-based therapies, including human pluripotent stem cells (hPSCs) and multipotent mesenchymal stem cells (MSCs), have become key players in regenerative medicine. The successful approval of cancer immunotherapy in the United States and mesenchymal stem cell (MSC) therapy in Europe has established regenerative medicine as a significant therapeutic approach, with treatment strategies focusing on disease management rather than mere cure.

Entering the second decade of the 21st century, Dr. Li Zhengdao remained steadfast on the frontlines of scientific research at the advanced age of 90. Recently, VCBeat conducted an exclusive interview with Dr. Li to gain deeper insights into the portfolio of regenerative medicine projects he and his team are advancing. Aimed at “ensuring that the elderly live with dignity,” this initiative not only introduces world-leading quality standards but also incorporates multiple breakthrough technological innovations, holding promise as a new engine for the development of regenerative medicine in China.

Li Zhengdao’s academic career began in immunology, where he achieved numerous pioneering results. In 1968, Li earned a Master’s degree in Immunology from McGill University in Canada, and subsequently obtained a Ph.D. in Immunology from Rutgers University in the United States in 1972.

His research career began at the Sloan Kettering Institute for Cancer Research (SKI) in the United States, where he helped establish the bone marrow transplantation program and achieved the world’s first identification of HLA-DR antigens. This discovery not only enriched the human gene pool but also brought revolutionary changes to fields such as organ transplantation, bone marrow transplantation, stem cell transplantation, transfusion medicine, paternity testing, and forensics.

During his tenure as Director of the Laboratory at the American National Red Cross headquarters and as Director of the Serum Bank at the U.S. National Institutes of Health (NIH), Li Zhengdao screened and acquired the world’s largest collection of HLA serum antibodies, accounting for approximately 60% of the global total. His research achievements not only garnered widespread attention in the academic community but also provided critical technical support for medical practice worldwide. Even physicians, including Nobel laureates from France, relied on Li Zhengdao’s team to provide comprehensive sets of serum antibodies for analyzing patients’ genes.

Furthermore, Li Zhengdao developed a high-resolution DNA methodology and provided Type II DR antibodies to address histocompatibility issues. This advancement further propelled the development of regenerative medicine and earned him a place among the world’s top scientists. Notably, Li was also one of the first scientists globally to integrate regenerative medicine with computer science. Under his leadership, the production cycle for regenerative medicine-related products was reduced by 90%, enabling them to be sold at one-fifteenth the price of competitors’ offerings.

During this period, a vision for translating scientific achievements into practical applications gradually crystallized in Li Zhengdao’s academic and research career. Li once candidly stated, “Medicine is my faith, but good medicine should benefit more people. The greatest happiness for a scientist is to see their research truly help those in need.”

This concept serves as a ray pointing toward the long-term technological development of the future. As immunology theories, cancer therapies, and regenerative medicine technologies undergo iterative updates, and even as these technologies continually encounter opportunities for industrial commercialization, the impact of this translation-oriented mindset will be reinvigorated.

This is the power of industry infrastructure.

During the Chinese Medical Association’s inaugural visit to the United States, Dr. Li Zhengdao had already established a prominent reputation in the field and was subsequently invited to return to China for a one-month lecture tour. Thereafter, Dr. Li returned to China annually to dedicate himself to research in immunogenetics and stem cells, promoting their advancement and widespread application in the country. In 1997, upon his return, Dr. Li assisted in establishing the world’s largest Chinese bone marrow registry.

He did not interrupt these infrastructure projects.

Li Zhengdao was successively invited to serve as an honorary professor at dozens of prestigious universities and institutions, including Peking Union Medical College, West China University of Medical Sciences, and Zhejiang University. He was received on multiple occasions by former State Councilor Li Tieying and former Minister of Health Chen Minzhang. Notably, he donated a mobile blood collection vehicle to Hangzhou, which became the city’s first vehicle dedicated to voluntary unpaid blood donation. This contribution marked a significant step in advancing China’s reform from paid to voluntary unpaid blood donation, thereby enhancing domestic blood donation and transfusion safety and facilitating the integration of China’s blood services with international standards.

Meanwhile, his foundational contributions to academia and scientific research have also earned him a significant role in the history of regenerative medicine development in China. By serving as an advisor and honorary professor at multiple institutions within the country, he has trained a large number of professionals in regenerative medicine without compensation. He has also donated regenerative medicine equipment worth tens of millions of RMB to domestic institutions, thereby advancing the fields of bone marrow transplantation, organ transplantation, and stem cell research in China.

In 2025, Tsung-Dao Lee entered his nineties, yet his footsteps never ceased.

“Medicine should not merely prolong life, but ensure that every moment of life is lived with dignity.”

When asked why he initiated the regenerative medicine project cluster, Li Zhengdao responded as follows. This perhaps reflects his healthcare philosophy, shaped by years of deep engagement in immunology, stem cell technology, and oncology treatment—shifting from merely treating diseases to comprehensively enhancing quality of life.

It is reported that the project cluster will establish Asia’s most rigorous clinical laboratory for regenerative medicine, introduce the AABB Association—widely recognized as the gold standard for quality in the industry—implement Dr. Li Zhengdao’s regenerative medicine quality management system, refined over 50 years, and apply AI-driven programs for data management in regenerative medicine. These initiatives, akin to foundational infrastructure for the regenerative medicine sector, will ensure the provision of “safe and effective” products, fully meeting consumers’ rigid demand for safety and efficacy.

This also marks the first time that Tsung-Dao Lee has personally spearheaded a cluster of regenerative medicine projects in mainland China. The vision is to establish key infrastructure for the regenerative medicine industry through these initiatives, thereby addressing the diverse needs driving the sector’s continuous growth and enabling “the elderly to live with dignity.” The term “the elderly” in the project title reflects this humanistic concern. In an era of accelerating population aging, such medical innovations aimed at improving the quality of life for older adults hold particular social significance.

The project cluster will also launch a globally pioneering technology that has completed its R&D phase and is ready for immediate implementation. At the core of this technology is the ability to serve more than 10,000 patients with a single umbilical cord. “Traditional methods of culturing umbilical cord tissue can treat at most two individuals,” explained Li Zhengdao. “In contrast, our technology can generate sufficient cells from a single umbilical cord to treat tens of thousands of people.”

Regarding the specific preparation method, preliminary work involves cutting the umbilical cord into small fragments, which are individually stored in 1-mL cryovials within liquid nitrogen dewars. When needed, a single vial can be retrieved to expand hundreds of billions to over a trillion cells, sufficient to serve up to 10,000 patients.

According to Li Zhengdao, this technology can achieve the capacity to serve 500 individuals by the third generation. As research and development progress, the technology has also enabled the stratification of populations into 20–30 ethnic groups based on race, with stem cell products matched to corresponding genes for each specific group.

Furthermore, this approach can avoid immune rejection and achieve a hundredfold increase in the production yield of cell-based products. This implies that the supply model for regenerative medicine is poised for transformation, while therapies will truly become personalized, significantly enhancing treatment efficacy.

Behind the successful expansion of cell products lies a stringent quality control system.

“Clinical laboratory management in Europe and the United States is highly stringent,” pointed out Li Zhengdao. “Since clinical laboratory products are directly used for patient treatment, laboratory directors typically hold an MD or PhD degree and must undergo two years of specialized professional training before being eligible to take the certification exam, which has an acceptance rate of only 10%.” It is worth noting that cells and exosomes are pharmaceutical-grade products whose manufacturing is characterized by the principle that “the process is the product.” Consequently, this imposes extremely high requirements on process management, making overall safety and end-to-end contamination control the core competitive advantages of the industry.

Furthermore, strict adherence to the quality control system is closely aligned with the philosophy of “enabling the elderly to live with dignity.” The core technology behind the “One Umbilical Cord Serving 10,000 People” initiative has resolved issues related to cost, source, and quality; however, to truly make it universally accessible, particularly for the advanced-age population, continuous refinement is required during the product implementation phase.

“Quality and safety are the foundation of industry development,” emphasized Li Zhengdao. “Without this foundation, even the most advanced technologies will struggle to benefit patients.” Throughout the interview, Li repeatedly stressed the terms “safety” and “efficacy,” underscoring the necessity of establishing a rigorous quality control system. Driven by his relentless pursuit of quality and safety, Li decided to systematize his over 50 years of research and management experience to build a set of “infrastructure” for regenerative medicine.

At the core of this “infrastructure” is a “trinity” quality management system.

What is the “Trinity”? First, there is the AABB accreditation system. Hailed as the gold standard for quality in the industry, this system ensures that the product quality of accredited enterprises gains global recognition. AABB-accredited cell therapy clinical laboratories will serve as the framework and cornerstone of the quality management system for this project.

Secondly, it is particularly worth mentioning the quality management system pioneered by Li Zhengdao, a KNOW-HOW management approach under the AABB framework. Quality management documents of domestic regenerative medicine companies typically contain only operational procedures (generally 5–30 pages). Under Li Zhengdao’s leadership, his team continuously iterated and updated these documents, refining and expanding the operational procedures to over 1,000 pages, thereby establishing a thousand-page-level standard operating protocol. This approach not only ensures greater executability but also guarantees compliance at the source.

Furthermore, within the quality management system of this project, an AI software system is employed to manage data across the entire regenerative medicine workflow, thereby further enhancing product quality.

In addition to planning and constructing Asia’s most rigorous clinical laboratory for regenerative medicine, another objective of the project cluster is to establish a complete chain from basic research to clinical application—that is, starting with basic research, translating scientific achievements into practical applications, and extending into industrial development.

Specifically, basic research will focus on the application of stem cells and exosomes in immune-mediated diseases, age-related conditions, and other fields. In terms of clinical translation, leveraging experience in building AABB-compliant laboratories, a stem cell infusion center meeting AABB standards is expected to be established. To connect with the industry and achieve self-sustaining growth, the project portfolio will also engage in CRO/CDMO services to support product development and certification within the sector. This diversified business mix is poised to form a closed-loop ecosystem during its implementation.

The project portfolio currently addresses two major health issues facing the elderly population: mobility impairment caused by joint degeneration, and the decline in oral function, which hinders their ability to enjoy food. Both conditions significantly impair quality of life in later years. It is reported that Li Zhengdao and his team are collaborating with universities such as Peking University to develop products aimed at restoring oral function in the elderly.

The adoption of AABB standards by the project consortium is precisely aimed at aligning China’s regenerative medicine sector with international practices. In the future, as more regenerative medicine products gain regulatory approval for market entry, the global market size will expand rapidly. This growth will drive domestic regulatory policies to keep pace, serving as a significant catalyst for the development of the related market. Multiple forces will converge to propel China’s regenerative medicine industry into a sector-wide gold rush.

The public’s awareness of Li Zhengdao stems largely from the lesson titled “The Life-Spanning Bridge Across the Strait” in Volume 7 of the Chinese language textbook published by People’s Education Press. In 1998, also driven by his efforts, the First Affiliated Hospital of Zhejiang University School of Medicine successfully completed its first bone marrow donation and transplantation, setting a precedent for successful cross-strait bone marrow transplants and providing an opportunity for more people to become acquainted with Li Zhengdao, known as the “Father of Serum Stem Cells.”

In fact, during the era when direct cross-strait travel was not yet established, Li Zhengdao made over a hundred trips under courtesy visas to escort matched bone marrow transplants, saving the lives of more than a hundred people. What is recorded in the textbook may have been just one of many ordinary days in his earthly life.

Today, Li Zhengdao has embarked on a new journey, openly acknowledging the transformative impact of regenerative medicine and working with his team to advance a portfolio of regenerative medicine projects. Whether it is AABB accreditation, Li Zhengdao’s own quality management consulting, CRO or CDMO services, regenerative medicine big data, or AI, these all represent “shovel-selling” businesses in the midst of a gold rush. They not only boast strong cash flow and healthy profit margins, but also readily build industry-level brand influence, with promising growth prospects.

At this stage, the team is actively engaging with government funds and systematically advancing the further implementation of the project.