Stem Cells in Clinical Practice: Ningbo University Hospital Opens a New Biological and Cell Therapy Center

Ningbo University Affiliated People’s Hospital launches a biological and cell therapy center focused on stem cells, CAR-T, and NK cell research under China’s national regulatory standards.

Ningbo University Affiliated People’s Hospital Opens a Dedicated Biological and Cell Therapy Center

How does a hospital responsibly bring stem cell and cellular therapies from the research laboratory into clinical practice? For Ningbo University Affiliated People’s Hospital, the answer begins with building a proper foundation.

On 5 February, the hospital officially inaugurated its Biological and Cell Therapy Center, marking its formal entry into one of medicine’s most actively developing fields. The center will focus on the clinical research and translational application of advanced cell therapies — including CAR-T, NK cells, and tumor-infiltrating lymphocyte (TIL) therapy — targeting hematological malignancies, solid tumors, and autoimmune diseases.

Clinical Focus: What the Center Will Do

The center has been established as a multidisciplinary platform combining clinical care, research, and medical education. Its work targets three disease areas where cellular therapies have shown the most clinically meaningful results internationally.

CAR-T Cell Therapy — Chimeric antigen receptor T-cell (CAR-T) therapy is currently one of the most clinically validated forms of engineered cell treatment. In China, CAR-T products have received regulatory approval from the National Medical Products Administration (NMPA) for certain hematological indications, and the center will conduct research and translational work in this area.

NK Cell Therapy — Natural killer (NK) cell therapy is an emerging approach with potential advantages in manufacturing and safety compared to some T-cell methods. Its inclusion positions the center at the leading edge of cellular immunotherapy development in the region.

TIL Therapy — Tumor-infiltrating lymphocyte (TIL) therapy involves isolating and expanding immune cells from a patient’s own tumor tissue, then reinfusing them. Together with CAR-T and NK cell programs, this gives the center a broad and clinically relevant scope across current cell therapy platforms.

Leadership and Academic Partnerships

The center is led by Dr. Pei Renzhi, a senior hematologist and academic leader at the hospital. In his opening address, Dr. Pei emphasized that cell therapy represents one of the most important directions in modern hematological medicine, and that the center’s work would remain grounded in clinical need and standardized practice.

The center also has formal academic advisory support from two senior professors at the Second Affiliated Hospital of Zhejiang University School of Medicine — Professor Qian Wenbin and Professor Xu Rongzhen — both of whom received letters of appointment at the ceremony. This collaboration gives the center direct access to the expertise of one of China’s leading academic medical institutions.

Professor Qian Wenbin committed to supporting the center’s alignment with national platforms in three critical areas: project registration, technical standards, and quality control — all essential to responsible regulatory compliance.

Regulatory Framework and Compliance

A key highlight of the inauguration was a dedicated session by Professor Xu Rongzhen, who outlined China’s national standards for the filing and approval of cell therapy projects, covering policy requirements and the technical specifications that govern clinical cell therapy programs.

In China, oversight is administered primarily by the National Health Commission (NHC) and the National Medical Products Administration (NMPA), covering cell sourcing, manufacturing conditions, quality testing, ethics review, and post-treatment follow-up.

This regulatory orientation aligns with global norms. Authorities including the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) have all developed dedicated frameworks for cell and gene therapy oversight — recognizing both the therapeutic potential and the distinct safety considerations of these treatments.

GMP Infrastructure and Cell Preparation

A central part of the center’s development is the construction of a Good Manufacturing Practice (GMP)-level cell preparation platform. GMP standards are internationally recognized quality requirements governing how biological products, including cellular therapies, are produced and tested before clinical use — and meeting these standards is a regulatory requirement under both Chinese and international norms.

Building this within a hospital setting requires controlled manufacturing environments, validated equipment, qualified personnel, and a comprehensive quality management system. The hospital’s commitment to establishing this infrastructure from the outset reflects a long-term, compliance-first approach to development.

Institutional Goals and Broader Significance

Hospital leadership connected the center’s establishment to China’s national “Healthy China” strategy, with the expressed aim of developing into a regional hub for cell therapy research and clinical application across eastern Zhejiang. Regional health authority representative Shi Boda encouraged the center to prioritize standardization and safety before scale — a position consistent with the cautious regulatory approach Chinese authorities have taken toward the broader expansion of cell therapy services.

Looking ahead, the center plans to initiate multi-center clinical research collaborations, advance its GMP preparation platform, contribute to specialist training, and progressively translate research into validated clinical protocols.

The establishment of this center reflects a wider global trend. Academic hospitals across the United States, Europe, Japan, and China are formalizing their capacity for cell-based medicine, driven by growing clinical evidence for CAR-T therapy and an expanding pipeline of cellular treatment candidates. Stem cells remain a foundational part of this landscape — coexisting alongside newer engineered cell approaches within integrated programs at leading institutions worldwide.

The center’s long-term credibility will rest on its continued adherence to national regulations, meaningful research partnerships, and an unwavering commitment to patient safety and clinical rigor.

Conclusion

The inauguration of the Biological and Cell Therapy Center at Ningbo University Affiliated People’s Hospital marks a structured and regulation-compliant step forward in regional cell therapy development. With a clear clinical focus on CAR-T, NK cell, and TIL therapy, a GMP-level preparation platform, and strong academic partnerships, the center is built on a foundation that prioritizes safety, standardization, and long-term compliance over rapid expansion.

As stem cells and advanced cellular therapies continue to reshape the treatment of blood cancers, solid tumors, and autoimmune diseases globally, developments like this reflect a broader and necessary shift — bringing clinically rigorous cell therapy closer to patients who need it most.