Has stem cell therapy been approved in China?

As a long-time observer of global biomedical developments, I've been asked repeatedly: “What exactly is China's progress in stem cell therapy? Has it truly been approved for clinical use?” Behind this question lies both anticipation for the miracles of regenerative medicine and scrutiny over whether China's rapid pace adheres to regulatory standards. Over the past decade, I've tracked China's stem cell policies, research, and clinical practices to address this query from a more multidimensional perspective.

I. Stem Cell Therapy: China's Role in the Global Race

Stem cells, with their unique ability to self-renew and differentiate into multiple cell types, are regarded as the “seed cells” of regenerative medicine. From repairing damaged tissues to treating diseases challenging to conquer with traditional medicine (such as spinal cord injuries, Parkinson's disease, and diabetes complications), scientists worldwide hold high hopes for them. The United States, the European Union, and Japan were early movers in this field. However, due to safety concerns (such as tumorigenic risks and immune rejection) and cautious regulatory approaches, only a limited number of stem cell products have been approved to date. For instance, the hematopoietic stem cell transplants approved by the U.S. FDA for hematologic malignancies are, strictly speaking, classified as “cell therapy” rather than broadly defined “stem cell therapy.”

China entered this field relatively late but has rapidly emerged as a global hub for stem cell research, leveraging its vast patient population, policy support, and substantial R&D investment. According to 2022 statistics from a Nature journal, China ranks second globally in stem cell-related publications and second only to the U.S. in clinical trial registrations. However, “research activity” does not equate to “unrestricted clinical application”—this distinction is crucial for understanding China's current stem cell therapy landscape.

II. China's Regulatory Framework: From “Unchecked Growth” to “Cautionary Regulation”

Before 2015, China's stem cell therapy sector descended into chaos due to regulatory gaps: some institutions bypassed formal procedures, luring patients with “cure-all” claims, and even caused infections through illegal injections. International media criticized China's rampant “stem cell tourism,” prompting tighter policies.

In 2015, the former National Health and Family Planning Commission and the China Food and Drug Administration jointly issued the “Administrative Measures for Stem Cell Clinical Research (Trial Implementation).” This regulation explicitly stated that “stem cell therapy shall not be charged directly to patients as a clinical service item.” All applications must be conducted in registered tertiary hospitals and strictly limited to “clinical research” (i.e., no efficacy guarantees could be promised). In 2019, the National Medical Products Administration (NMPA) further classified stem cells as “biological products,” requiring complete safety and efficacy data for drug applications—meaning stem cells must undergo rigorous three-phase clinical trials similar to those of the U.S. FDA to be formally approved as drugs.

The current status is: As of 2024, China has not approved any stem cell product for formal market launch as a “drug” for clinical treatment. However, two caveats must be added to this conclusion: First, some stem cell preparations have entered the clinical trial phase; second, the boundary between “clinical research” and “clinical application” is being cautiously explored.

III. Attempts at “Pre-Approval”: Clinical Trials and Limited Scenarios

Despite lacking “marketing authorization,” China has not halted its exploration. Currently, approximately 60 stem cell clinical trials are registered with the Center for Drug Evaluation (CDE) under the National Medical Products Administration (NMPA), covering diseases such as graft-versus-host disease (GVHD), ischemic heart disease, and spinal cord injury. Among these, some projects have advanced to Phase II or even Phase III, including:

• Graft-versus-Host Disease (GVHD): A clinical trial utilizing umbilical cord mesenchymal stem cells demonstrated a symptom remission rate exceeding 50% in patients. The findings were published in the international journal Stem Cell Translational Medicine.

• Retinal disease treatment: Some hospitals are collaborating with biotech companies to explore stem cell-based repair of retinal damage. Individual case reports indicate vision improvement, though large-scale validation remains necessary.

Furthermore, under the category of “medical technology” rather than “medicines,” China permits certain registered stem cell clinical studies to provide treatments to patients—though this differs fundamentally from “market approval”: patients must sign informed consent forms, treatment costs are typically covered or partially waived by the research institution, and efficacy data must be submitted to regulatory authorities for evaluation.

IV. Controversies and Challenges: Safety, Ethics, and International Dialogue

Foreign concerns often center on two questions: “Is China ‘relaxing’ standards?” and “Are these treatments truly safe?”

In reality, China's regulatory logic has never been relaxed. In 2021, a stem cell institution had its license revoked for conducting clinical applications in violation of regulations. In 2023, the CDE explicitly required complete data from “non-clinical safety evaluations” (including long-term carcinogenicity studies) for stem cell drug applications. Safety remains an absolute red line.

Ethically, China's restrictions on embryonic stem cells align with international norms (only established cell lines are permitted), while mesenchymal stem cells—often derived from adult tissues like umbilical cords and fat—face fewer ethical controversies.

In international discourse, China's progress is gaining recognition. For instance, in 2022, a stem cell drug developed by a Chinese team received EU Advanced Therapy Medicinal Product designation, signifying its development process meets international standards.

Conclusion: Cautious Optimism, Not “Miracle Selling”

Returning to the initial question: “Has stem cell therapy been approved in China?” The answer is no—as a “drug,” no products have yet reached the market; but as “research,” China is at the global forefront.

Foreign observers often focus on “whether it's open,” but what deserves greater attention is how China balances innovation with risk. As one policy expert involved in decision-making stated: “We don't reject the hope stem cells bring, but we must ensure every step is grounded in science.” For patients, this means: Don't blindly believe rumors that “China has approved stem cells as a cure-all,” but also don't overlook the groundbreaking explorations unfolding here that could rewrite medical history.

In the coming years, as more clinical trial data emerges, stem cell drugs may gain approval in China first, which would be the best answer to balancing “scientific rigor and clinical need.”

Document dated 2025-11-13 14:52 Modify