Approved Stem Cell Therapy for Type 2 Diabetes at Lecheng Ciming

Since December 30, 2025, when the Hainan Boao Lecheng Medical Pilot Zone approved Ciming Boao International Hospital to conduct the “human umbilical cord mesenchymal stem cell therapy for type 2 diabetes” program, patient interest has been substantial. This approval, issued under Document No. Lecheng Medical Drug Supervision [2025] 113, authorizes the hospital’s endocrinology department to treat patients who meet a specific criterion: those using at least three glucose-lowering agents (including insulin) with persistently poor glycemic control. The cell product, manufactured by Shenzhen Beike Biotechnology, is administered via intravenous infusion at a dosage of 1 × 10⁶ cells/kg per session, once weekly for three consecutive weeks.

As a service coordinator based in the Lecheng pilot zone, I work with patients from across China who are exploring this option. This article compiles the most current and objective information available about the program—drawn directly from official regulatory documents, the hospital’s patient materials, and peer-reviewed clinical evidence—to assist patients and their families in making informed decisions.

Type 2 diabetes is a chronic metabolic disorder in which the body’s cells become resistant to insulin and the pancreas gradually loses its ability to produce enough insulin to overcome that resistance. Over time, this leads to progressive β-cell dysfunction. In the first decade of the disease, β-cell function declines by approximately 10%, followed by a more rapid decline of about 10% every two years. Conventional treatments—diet, exercise, oral medications, and insulin—aim to manage blood glucose levels but do not address the underlying loss of β-cell function.

Mesenchymal stem cells (MSCs), particularly those derived from human umbilical cord tissue (hUC-MSCs), have been studied extensively for their potential to modify the disease course. They offer several advantages: low immunogenicity, anti-inflammatory properties, immunomodulatory capacity, and the ability to home to sites of injury. Importantly, hUC-MSCs are ethically accessible, exhibit high proliferation potential, and carry a low risk of viral transmission.

The mechanism of action does not involve replacing pancreatic tissue but rather creating conditions that enable the body to restore its own regulatory capacity. MSCs act through three primary pathways:

The goal is not to achieve instant “insulin independence” but rather to shift the metabolic balance so that the patient’s own pancreas can assume a greater share of the workload over time.

One of the most frequently asked questions is whether the therapy is genuinely effective. A peer-reviewed paper published in the World Journal of Diabetes examined the efficacy and safety of hUC-MSC therapy for type 2 diabetes. The study enrolled patients aged 18–70 with confirmed type 2 diabetes and baseline HbA1c levels between 7% and 9.5%. Participants received three intravenous infusions of hUC-MSCs at a dose of 1 × 10⁶ cells/kg, administered one week apart.

A broader meta-analysis published in Tissue & Cell, aggregating 17 studies involving more than 8,000 patients, reported three measurable outcomes:

• HbA1c reduction: An average decrease of 1.45%. For a patient starting at 8.5%, this typically brings the level below 7%, the generally accepted target for optimal diabetic control.
• Reduced insulin requirements: An average reduction of 2.05 U/kg per day. Some patients have been able to reduce their insulin significantly or discontinue it entirely.
• Increased C-peptide levels: C-peptide is a direct marker of the pancreas’s own insulin production. Rising levels indicate that residual β-cells are recovering function.

Case reports from the Lecheng Ciming program reflect these patterns. One patient with an 8-year history of type 2 diabetes experienced a reduction in HbA1c from 8.2% to 6.7% and was able to discontinue insulin entirely. Another patient, who had been insulin-dependent for nine years, likewise achieved complete cessation of insulin after treatment.

It is important to note that these are individual cases and that outcomes vary. Published clinical trial data provide the most reliable evidence base, while the program continues to collect real-world data through structured follow-up.

The regulatory approval sets out clear inclusion criteria. The therapy is indicated for patients who meet all of the following conditions:

• Diagnosis of type 2 diabetes (not type 1 or other forms).
• Currently using at least three glucose-lowering agents, including insulin.
• Persistently poor glycemic control despite this combination therapy.

Exclusion criteria are equally important and are assessed during a comprehensive pre-treatment evaluation at the hospital. These include, but are not limited to: positive GAD antibodies (indicating autoimmune diabetes), severe cardiovascular disease, significant hepatic or renal impairment, active infections, known malignancy, and pregnancy. All candidates undergo laboratory testing, including HbA1c and C-peptide measurement, to confirm eligibility.

The treatment protocol is straightforward and is performed on an outpatient basis. Each course consists of three intravenous infusions administered at weekly intervals, with each infusion delivering 1 × 10⁶ cells per kilogram of body weight.

The typical patient journey follows the sequence outlined below:

1. Remote consultation and record review: Patients submit medical history, recent laboratory results, and current medication lists for preliminary screening.
2. On-site evaluation: A comprehensive assessment at Lecheng Ciming, including blood tests, endocrinology consultation, and confirmation of eligibility.
3. Informed consent and scheduling: If eligible, the patient signs consent forms and schedules the three infusion sessions.
4. Infusion sessions: Each session takes approximately one hour, followed by a one-hour observation period. No hospitalization is required.
5. Post-treatment monitoring: Follow-up assessments at 4, 8, and 12 weeks post-treatment to track glycemic control and C-peptide response.

From a service perspective, our team assists with travel arrangements, accommodation, appointment scheduling, and translation services, ensuring a smooth experience for patients traveling from other provinces or countries.

After nearly six months of operation, the hospital has revised its overall treatment fees. Pricing is currently weight-based, as the cell dosage is calibrated to body mass:

These figures cover the cell product, medical procedures, and hospital services, but do not include travel, accommodation, or ancillary medications. The hospital provides a detailed cost breakdown during the consent process.

The Lecheng Ciming Project operates with the formal approval of the Lecheng Pharmaceutical Administration and is part of the regulatory framework for new biomedical technologies in the pilot zone. This framework requires ongoing real-world data collection and reporting. The cell product is manufactured under GMP conditions and has passed rigorous sterility, potency, and identity testing.

The safety profile of umbilical cord-derived MSCs is well established. To date, no tumor formation or severe immune reactions have been reported among treated patients, a finding consistent with the broader clinical experience with these cells. Transient, mild reactions—such as low-grade fever or infusion-site discomfort—have been reported but are generally self-limiting.

It is essential to emphasize that this therapy is intended as a supplement to—not a replacement for—standard diabetes care. Patients are advised to continue their prescribed medications and to maintain regular follow-up with their primary endocrinologist.

Conventional diabetes treatments—metformin, sulfonylureas, DPP-4 inhibitors, GLP-1 receptor agonists, and insulin—are effective in managing blood glucose levels. However, they do not halt the progressive decline in β-cell function. Stem cell therapy targets the underlying pathophysiology by modifying the inflammatory environment and supporting the recovery of endogenous insulin secretion.

In practice, stem cell therapy works alongside conventional treatments. As patients’ pancreatic function improves, it becomes possible to gradually reduce the doses of glucose-lowering medications. The goal is not to abandon established therapies but to reduce dependence on them—moving from “high-dose dependency” to “low-dose maintenance” and, in some cases, to the complete cessation of insulin or oral agents.

This complementary approach is reflected in the program’s inclusion criteria, which specifically target patients who have already tried multiple conventional agents without achieving adequate control.