In China, there are more than 100 million diabetic patients. Stem cell therapy has attracted attention as an emerging therapy, but the popularity rate is low due to regulatory restrictions and the stage of clinical trials. Most treatments are not widely available.
As a common and serious chronic disease, the incidence of diabetes in China is on the rise, bringing a heavy financial and emotional burden to many families.
With the change of lifestyle and the intensification of the aging population, the number of diabetic patients has increased dramatically in recent years, and according to the "Report on the Prevention and Treatment of Diabetes in China (2020)", the prevalence of diabetes in China is about 11.2%, which means that about 114 million adults have diabetes. This makes diabetes and its complications an important part of the country's public health problem.
Against this backdrop, there is a growing need for diabetics and their families to find effective treatments. In particular, stem cell therapy, as a cutting-edge medical research field, has attracted widespread attention.
Stem cell therapy is thought to potentially provide a new therapeutic avenue for diabetes and its complications. As a result, many fans of diabetics have asked us in the background where to find hospitals or research institutes that offer stem cell therapy. They hope that through this innovative treatment, it is possible to find a way to control or cure diabetes.
However, regrettably, there are very few diabetic patients who can receive stem cell therapy in China, and the main reasons for this are as follows:
1. Stem cell therapy in China is still in the clinical trial stage
According to relevant reports from various media, the National Health Commission has expressed the attitude of cell therapy: except for hematopoietic stem cell transplantation for the treatment of blood diseases, other cell therapies are all in the clinical research stage and cannot be used for clinical treatment for the time being.
At present, domestic stem cell products are still in the clinical trial stage, and only 127 stem cell clinical research projects have been completed. Together, this information shows that although stem cell therapy has received widespread attention in China, most of the treatments are still in the research and trial stage and have not yet been widely used in clinical treatment.
For example, stem cell therapy is still in the clinical research stage, just like a restaurant is currently in the stage of developing dishes, and there are very few people who can enjoy "tasting". The reason for this is that at present, domestic stem cell therapy is facing many tests such as "the need to verify the safety and efficacy", "the maturity of technology and clinical application to be verified", and "the ethical issues of stem cell technology".
2. Strict supervision by the state, "double-line and dual-filing system" for clinical research
From 1993 to the present, there are at least 9 regulations related to stem cell therapy in mainland China, among which Article 6 of the General Provisions of the Administrative Measures for Stem Cell Clinical Research (Trial) issued in 2015 clearly states that "institutions shall not charge subjects for stem cell clinical research-related fees, and shall not publish or disguise stem cell clinical research advertisements." ”
Fees are not allowed, which means that commercialization has not yet begun, and it is equivalent to telling the public that "stem cell therapy for money is not legal". Of course, there is also a gray industry of "introducing stem cells", and if diabetic patients encounter the "opportunity" of "receiving tens of thousands to hundreds of thousands of yuan to participate in stem cell therapy clinical trials", please consider carefully.
At the institutional level, the clinical research and application of stem cells in China need to obtain the filing approval of two departments at the same time, namely the National Health Commission and the Food and Drug Administration. This system aims to strengthen the regulation of stem cell therapy and ensure the safety and effectiveness of the treatment.
Specifically, the first line is the regulation of stem cell drugs, which is mainly handled by the State Food and Drug Administration (NMPA). If a stem cell company chooses this route, it needs to apply for an IND application, and after approval, conduct phase I, phase II, and phase III clinical trials in accordance with the standards of the drug, and finally obtain the new drug marketing approval.
The second line is the supervision of stem cell medical technology, which allows medical institutions to apply for dual filing of institutions and projects in the secretariat jointly managed by the Health Commission and the Drug Administration, and carry out stem cell clinical research within the scope of the filing project. This approach is relatively flexible and is suitable for stem cell technologies that are not yet fully compliant with drug regulatory requirements but have shown potential therapeutic benefits.
The implementation of this "two-line and dual-filing" system is to ensure that stem cell therapy can undergo rigorous scientific verification and regulatory review before promotion and application, so as to protect the safety of patients and the effectiveness of treatment. At the same time, it also reflects China's cautious and strict regulatory attitude in the field of stem cell therapy.
3. There is no stem cell therapy in the "Medical Guidelines", and the doctor does not bear the risk
There is no stem cell therapy in the "diagnosis and treatment guidelines" related to the treatment of diabetes, and hospital doctors are required to follow the "clinical diagnosis and treatment guidelines" in clinical practice. These guidelines usually include relevant regulations and procedures such as rational drug use principles, drug inserts, clinical diagnosis and treatment guidelines, and clinical pathways, with the aim of ensuring the quality of care and patient safety.
If doctors don't follow these clinical guidelines, there are a number of risks involved. First, failure to follow guidelines can lead to poor treatment outcomes or treatment errors, increasing the health risks for patients. In addition, this practice may violate the regulations of the medical institution and medical regulations, and may lead to medical disputes or legal liability.
Although many experts in the medical field have a recognized attitude towards stem cell therapy, and 12 stem cell treatments have passed the "expert consensus". However, "expert consensus" is a consensus among experts from multiple disciplines on a specific clinical problem based on their experience and the limited evidence available in certain cases where there is insufficient evidence to support the development of guidelines. Therefore, "expert consensus" is not the basis for clinical treatment.
Moreover, in serious cases, medical malpractice resulting from non-compliance with medical guidelines can have a detrimental impact on the reputation of the hospital and the doctor's career. Therefore, even if they know that stem cell technology can treat some incurable diseases, including diabetes, most doctors will not take the risk.
4. The medical community has doubts about stem cell therapy
There are some doubts in the medical community in China about the therapeutic effects and risks of stem cell therapy, which are mainly concentrated in the following aspects:
- Safety and efficacy: Although stem cell therapy has shown potential in some areas, its long-term safety and efficacy remain a major concern for the medical community. The unknown side effects and long-term health effects that stem cell therapy may bring are not fully understood.
- Standardization of treatment: Standardization and normalization of stem cell therapy is another point of concern. Due to the diversity of stem cell sources, extraction, and treatment methods, different treatments may have different effects, which poses challenges to the evaluation of treatment effects and the standardization of treatments.
- Ethical and legal issues: Stem cell research and treatment also involves ethical and legal issues, such as the use of embryonic stem cells, which are controversial in both the medical community and society.
- Cost and accessibility: The high cost of stem cell therapy is also a point of concern. Currently, many stem cell therapy technologies are not widely available and expensive, which limits their accessibility to the general population.
- Gaps in research and clinical applications: While there has been a lot of progress in stem cell research, there are still gaps in translating these findings into practical clinical applications. How to effectively translate the results of basic research into clinical treatment is a problem that needs to be solved by the medical community.
- Regulatory and quality control: Regulatory and quality control of stem cell therapy is also a concern for the medical community. It is important to ensure that all stem cell products used in the treatment process meet strict quality standards and regulatory requirements to protect patient safety.
Despite these concerns, the domestic medical community is also actively promoting the research and clinical application of stem cell therapy, through the development of expert consensus, clinical trials and the establishment of a regulatory system, in order to address these concerns and promote the development of stem cell therapy technology.
Patients can pay attention to the clinical trials of stem cell therapy that have been filed and register through legal channels
At present, although the majority of diabetic patients cannot directly obtain stem cell therapy, they can pay attention to the relevant clinical trials that have been filed and are being conducted. These trials, which aim to explore the efficacy and safety of stem cell technology in the treatment of diabetes, are at the forefront of medical research. By participating in these documented clinical trials, people with diabetes not only have the opportunity to stay up-to-date on the latest medical advances, but may also directly benefit from emerging treatments.
Patients and their families can also pay close attention to medical research trends at home and abroad, and sign up for qualified research through legal channels in order to grasp possible treatment opportunities. Medical institutions and research institutes are valuable resources for those seeking more information and avenues to get involved.
The picture above is a clinical trial of stem cell therapy for diabetes-related conditions that has been filed so far, and I hope it will be useful to you.
In addition, stem cell therapy services for diabetic patients are available abroad, but whether these services are covered by local medical insurance varies from country to country. As:
1. Malaysia: Malaysia provides stem cell therapy services, but there is no clear information on whether it is covered by medical insurance. The average cost of stem cell treatment in Malaysia is US$19,000.
2. Georgia: Cell therapy centers in Georgia provide stem cell therapy services, especially in the treatment of type 1 and type 2 diabetes. The center has ISO 9001:2015 certification for the international quality management system.
3. Germany: TICEBA in Germany is an authoritative institution for stem cell treatment of diabetes, with German official medical qualification certification and German autologous stem cell medical operation authorization under EU standards.
However, information on whether these services are covered by local health insurance is not open and transparent. Patients should consult their medical institutions and local health insurance policies when considering these treatments.
Bibliography:
- Guidelines for the Prevention and Treatment of Type 2 Diabetes in China (2020 Edition): https://rs.yiigle.com/CN115791202104/1315485.htm
- Clinical Diagnosis and Treatment of Type 2 Diabetes Mellitus (Western Medicine) (2021 Edition): http://www.duyaonet.com/_FileUpLoad/20211207/20211207134550.pdf
- Guidelines for the prevention and treatment of type 2 diabetes in China: https://www.whcdc.org/upload/old_file/201906/234234234245234.pdf
- Clinical guidelines for the prevention and treatment of type 2 diabetes mellitus in the elderly in China (2022 edition): https://www.whcdc.org/upload/20220720/62d7c68b403f0.pdf
- 【People's Daily】The prospect of stem cell technology for disease treatment is promising: https://bjb.cas.cn/mt/202201/t20220107_6336572.html
- In 2024, 12 stem cell therapies have passed the Expert Consensus: https://zhuanlan.zhihu.com/p/695158508
- Central media reported that the level of stem cells in mainland China is "comparable" to the international and at the forefront of the world: https://www.cn-healthcare.com/articlewm/20220729/content-1409097.html
- 190,000 patients confirmed that stem cell therapy is moving from theory to clinical practice: https://www.cn-healthcare.com/articlewm/20230511/content-1548936.html
- China has made a number of breakthroughs in the clinical transformation of stem cells, and it is still necessary to break through bottlenecks such as ethical disputes: https://www.thepaper.cn/newsDetail_forward_1744838
- There are more than 860 stem cell research projects in China, which is in the first echelon of the world: https://www.cn-healthcare.com/articlewm/20211229/content-1301120.html
- Stem cell therapy: Do you still have doubts? There are 9 major diseases that have been clearly agreed by experts: https://cj.sina.com.cn/articles/view/3215693603/bfab9723001010jyo
- Stem Cells: China and the United States Face the Same Challenges in Stem Cell Therapy Regulation: https://www.cn-healthcare.com/articlewm/20220913/content-1434289.html
- Now the hot topic: what is stem cell clinical? How far is it from the common people? ：https://tech.chinadaily.com.cn/a/202012/25/WS5fe54693a3101e7ce9737631.html