China's Stem Cell Clinical Research Achieves Another Breakthrough; Further Efforts Needed to Transition from Laboratory to Universal Accessibility

Ask AI · How can China’s stem cell industry achieve breakthroughs in large-scale production?

21st Century Business Herald Reporter Yan Shuo Han Liming

On March 19, the cell immunotherapy concept sector in the A-share market experienced a noticeable decline compared to the previous trading day. Among them, Borui Medicine (688166.SH) and Zhongyuan Xiehe (600645.SH) saw stock prices retreat by over 2.5%; Kain Health (300272.SZ) declined by 3.18%, and InnoS (688710.SH) had the most significant drop at 7.3%.

Although the performance of related sectors in the A-share market has pulled back due to market fluctuations, major scientific achievements from the research front have injected long-term confidence into industry development.

Recently, the Cheng Xin research team from the Center for Excellence in Molecular and Cellular Sciences (Institute of Biochemistry and Cell Biology) of the Chinese Academy of Sciences, in collaboration with Professor Yin Hao’s team from the Second Affiliated Hospital of Naval Medical University (Shanghai Changzheng Hospital), successfully conducted minimally invasive transplantation of regenerative islets (E-islet) derived from autologous and allogeneic stem cells, achieving pancreatic function reconstruction and autonomous blood glucose regulation in Type 1 diabetes patients. The related research paper was published in the top international academic journal The Lancet Diabetes & Endocrinology.

Industry insiders believe that stem cell therapy has shifted from a “theoretical outlook” to a “clinical reality,” and the era of standardized and large-scale development of China’s stem cell industry is accelerating. However, it is important to note that there are still many bottlenecks to overcome from clinical validation of scientific results to widespread market application.

Currently, cell therapy product development is rapidly advancing worldwide, offering new treatment ideas and opportunities for various difficult-to-treat diseases such as autoimmune diseases, cancer, genetic disorders, and rare diseases. With ongoing clinical research validating safety and efficacy, the global market size for cell therapy is expected to grow steadily, from $9.5 billion in 2021 to $23 billion in 2028.

Although China started relatively late in stem cell research, it has quickly become one of the most active regions globally. According to the U.S. ClinicalTrials.gov database, China is currently the second-largest country in the world for registered stem cell clinical trials, after the United States.

Reports indicate that the exploratory clinical study conducted by the Cheng Xin team in collaboration with Professor Yin Hao has been successfully implemented in three Type 1 diabetes patients. The team used regenerative islets (E-islet) derived from autologous or allogeneic embryonic stem cells for treatment, and under different immunosuppressive strategies, systematically evaluated the efficacy and safety of the therapy.

It is reported that the independently developed “Allogeneic Human Regenerative Islet Injection (E-islet01)” has received new drug clinical trial (IND) approval in China in April 2025 and in the United States in January 2026. Currently, related clinical trials are being conducted in an orderly manner.

A PhD from the School of Chemistry and Materials Science at the University of Science and Technology of China, specializing in islet research, told the 21st Century Business Herald that this technological breakthrough is significant. First, it establishes a “research benchmark.” “In the past, stem cell treatments for diabetes were mostly theoretical in labs; now, clinical data published in The Lancet confirms the clinical feasibility of this approach, boosting confidence for further R&D and injecting momentum into industrial financing.”

Secondly, “the full industry chain” synergy is beginning to show. The core of this breakthrough lies in establishing an endodermal stem cell system, which not only overcomes technical barriers in upstream seed cell expansion but also promotes the localization of midstream islet organoid construction and downstream minimally invasive intervention technologies, completing a closed-loop from theory to practice.

Finally, the “industry margin” has achieved cross-generational breakthroughs. Stem cells are transforming from “precision consumables” in laboratories into “active biopharmaceuticals” targeting islet failure and insulin independence. This not only attracts more researchers but also accelerates the upgrade of domestic regulatory systems and large-scale production lines.

However, the expert also admits that there is still a long way to go from “clinical breakthroughs” to “public benefit.” The primary bottleneck is the lack of standardized, automated large-scale production systems.

He explained that currently, stem cell preparation resembles “high-end handcrafted products” in labs, heavily reliant on manual experience with large batch-to-batch variability. To achieve widespread accessibility, it is necessary to transform “workshop-style” production into highly automated “cell factories,” where billions of stem cells are precisely induced within large bioreactors to differentiate into functional islets. This involves not only biological challenges but also complex engineering issues such as fluid dynamics, metabolic oxygen supply, and tumorigenicity risk monitoring.

“If we cannot reduce the cost of single treatments from astronomical figures to a level covered by medical insurance through scale effects, even the most groundbreaking scientific breakthroughs will remain in the lab. The goal is to turn ‘nan-level’ precision experiments into ‘ton-level’ industrial miracles,” the expert added.

Globally, the development of stem cell-related therapies is still in its infancy, with countries accelerating their scientific and industrial deployment.

For example, on January 2, 2025, the National Medical Products Administration (NMPA) conditionally approved the first Chinese stem cell therapy drug, Amimaituo Sa injection, through a priority review process, for treating steroid-refractory acute graft-versus-host disease (aGVHD) mainly affecting the digestive tract in patients over 14 years old.

As the only “medical special zone” in China, the Boao Lecheng International Medical Tourism Pilot Zone in Hainan allows medical institutions to use internationally advanced drugs, medical devices, and technologies not yet approved in China. In March 2025, the zone announced clinical pricing for three stem cell therapies for knee osteoarthritis, chronic obstructive pulmonary disease (COPD), and heart failure, priced at 36,000 yuan, 150,000 yuan, and 180,000 yuan respectively.

While scientific and industrial efforts are pushing forward the transformation of stem cell technology, market chaos has also emerged: stem cell infusion services have quietly appeared in many beauty salons, private hospitals, cell companies, and even some departments of public hospitals. For ordinary consumers, how to accurately identify compliant stem cell products and services has become an urgent issue.

The PhD from the School of Chemistry and Materials Science at the University of Science and Technology of China emphasized that identifying compliant stem cell products and services mainly depends on “two certificates and one location”: the clinical trial approval (IND) from the NMPA or the clinical research record from the National Health Commission, and must be conducted in qualified tertiary hospitals. Any claims of “anti-aging” infusions at beauty salons or health centers with high charges are illegal.

He pointed out that the chaos in the industry stems from information asymmetry driven by high profits and regulatory gray areas. “Stem cells are being mythologized as ‘panacea,’ exploiting patients’ fears of disease to harvest ‘IQ taxes.’ Moreover, since stem cells have dual attributes of drugs and medical technologies, past regulatory responsibilities were inconsistent. Illegal institutions bypass costly clinical-grade quality control, disrupting the market with very low technical thresholds.”

“As researchers, we are most worried about this ‘bad money drives out good,’” he said, “before the technology truly benefits everyone, it has already eroded public trust.”

However, regulators have been intensifying efforts. The Regulations on the Clinical Research and Transformation of New Biomedical Technologies (hereafter Regulations) will come into effect on May 1, 2026, clearly defining approval pathways and regulatory requirements in cutting-edge fields like cell therapy and gene editing.

The expert believes that the Regulations are a “coming of age” for the stem cell industry, reshaping the ecosystem through a dual approach:

On one hand, the regulations limit qualification to tertiary hospitals and introduce the strictest penalties—fines up to 20 times and lifelong bans—targeting illegal activities at beauty salons and health centers, restoring seriousness to stem cell medicine.

On the other hand, the new rules clarify the transformation application pathways, significantly shortening approval cycles. This breaks the “ceiling” from laboratory to clinic, allowing China’s independently developed pancreatic regeneration technology to benefit patients more quickly and legally.

“Although the Regulations establish a full-chain closed loop, ‘root removal’ still requires continuous refinement of supporting rules,” he emphasized. “The implementation of the Regulations marks the industry’s true move into the rule of law era. Only by shedding false hype can our hard-earned scientific results dignifiedly reach the market.”