干细胞治疗 z-bio 2026-02-04 917

　　"Doctor, I heard that stem cells can cure diabetic foot, why doesn't your hospital do it?" Doctors often encounter this kind of question from patients in outpatient clinics.It’s not that tertiary hospitals are unwilling to carry out stem cell treatment, but that this technology faces strict thresholds, coupled with the practical considerations of the medical system, making it difficult to popularize it on a large scale.

　　Stem cell therapy is clearly classified as a third-category medical technology and is a high-risk medical project. The National Health Commission has drawn a red line: it must be approved by official registration before it can be carried out. It is illegal to practice medicine without registration.At present, there are more than 100 institutions nationwide that have registered for stem cell clinical research. Even so, compared with the thousands of tertiary hospitals across the country, they are still very few.

　　The core competitiveness of stem cell therapy lies in cell quality, and its preparation conditions are harsh.The cells need to be cultured in a GMP standard sterile laboratory, and the temperature, humidity, and nutrients need to be controlled to the decimal point. The final product needs to be stored in a -196°C liquid nitrogen tank for long-term storage. Contamination must be strictly prevented throughout the process to ensure activity.Once the cells are contaminated or have insufficient activity, not only the therapeutic effect cannot be achieved, but also complications such as serious infection may occur. This is a medical risk that neither hospitals nor patients can afford.

　　There are significant individual differences in the efficacy of stem cell therapy.Taking the treatment of spinal cord injury as an example, after transplantation of the same batch of stem cells, some patients can regain a certain ability to walk, but some patients have little effect.Even among more mature osteoarthritis treatments, about 15% of patients do not achieve the expected efficacy, and long-term safety data are still accumulating.Faced with this technology that is not yet fully mature, routine treatment will not be carried out easily.

　　In addition, the affordability of the medical insurance system is an important reason why it is difficult for stem cell therapy to enter tertiary hospitals on a large scale.The current cost of stem cell treatment is high. Taking the type 2 diabetes stem cell treatment piloted in Boao Lecheng as an example, the total cost of three courses of treatment is about 174,000 yuan, while the single cost of cell therapy such as CAR-T can reach 120,000-150,000 yuan.If it is directly included in medical insurance, under the pressure of existing social security funds, medical insurance resources for other basic diseases will inevitably be squeezed, affecting the protection of critically ill patients.

　　The 2026 policy has made a clear signal: stem cell therapy will not be fully included in basic medical insurance for the time being, but will be implemented on a "pilot basis first and supplemented by commercial insurance".At present, only hematopoietic stem cell transplantation (used for 12 types of severe blood diseases such as leukemia and aplastic anemia) is included in medical insurance, and the reimbursement ratio varies between 50% and 90% depending on the region and insurance type. The first stem cell drug, Amymetose injection, has been included in the innovative catalog of commercial health insurance, and inclusive commercial insurance can reimburse up to 65%, but it is still not covered by basic medical insurance.This gradual advancement not only reduces pressure on social security funds, but also reserves time for verification of technology maturity.

　　Stem cell therapy pilot projects in registered hospitals have achieved clear results, and treatment options for some diseases are becoming increasingly mature:

　　1) Diabetic foot: After treatment, 5 patients in Shaanxi Provincial People's Hospital all had ulcers healed with no recurrence for 1 year; Boao Lecheng has included umbilical cord mesenchymal stem cells in the treatment of type 2 diabetes in a pilot program, targeting patients with poor drug treatment effects.　

　　2) Autoimmune diseases: Beijing Hospital used umbilical cord mesenchymal stem cells to treat systemic lupus erythematosus. The patient's urinary protein dropped by 60%, which is expected to get rid of hormone dependence and bring new hope to patients with this type of difficult disease.

　　3) Other fields: Stem cell treatments for COPD, heart failure, acute graft-versus-host disease and other diseases have been piloted in Ruijin Hainan Hospital, West China Lecheng Hospital and other institutions.

　　Patients need to strictly review the hospital qualifications, and treatment must be carried out in a formal institution registered with the National Health Commission. Before treatment, a formal agreement must be signed to clarify the follow-up responsibilities for at least one year; the condition must be evaluated by the multidisciplinary team of a tertiary hospital; if you want to try cutting-edge technology, you can pay attention to pilot projects in pilot areas such as Hainan Boao Lecheng, and some projects can enjoy commercial insurance compensation.

　　As of January 27, 2026, the information on the number of stem cell clinical research registration institutions and registration projects in my country is shown below (a partial list based on public information). Stem cell registration projects must be reviewed by the National Stem Cell Clinical Research Expert Committee and must not charge patients.

　　Data sources: National Health Commission official website, Medical Research Registration Information System (http://www.mrrs.org.cn), China Medical and Biotechnology Association (http://www.cmba.org.cn)