exosomes treatment group: GoldenExo（NATX） treatment group (n=32) The specific therapeutic dose for the second stage will be evaluated and determined jointly by the investigators and the Safety Monitoring Committee (SMC) after all three dose escalation trials (1×10¹¹, 3×10¹¹, 9×10¹¹ particles) in the first stage.Subjects in both groups will receive intravenous infusions once weekly for 8 weeks (a total of 8 doses).
control group: active-comparator control：（n=16）The control group will receive an equal volume of the same buffer solution without exosomes (.Subjects in this groups will receive intravenous infusions once weekly for 8 weeks (a total of 8 doses)
Study summary
The goal of this clinical trial is to Evaluate the Safety and Preliminary Efficacy of Human Umbilical Cord Mesenchymal Stem Cell-Derived Exosomes in the Treatment of Adult Type 2 Diabetes Mellitus.
Eligibility
Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
Inclusion Criteria:
1. Age 18-65 years, diagnosed with T2DM for ≥5 years (\<20 years).
2. Regular diet and exercise control combined with the following intensive treatment regimens, with screening HbA1c remaining between 7.5% and 9.0% (FBG \<13.9mmol/L):Stable dose of insulin (basal or premixed) (\<1.5u/kg·d) combined with ≥1 oral antidiabetic drug (OAD) (e.g., Metformin, SGLT2i) for ≥3 months; or Insulin combined with a GLP-1RA (maximum tolerated dose, ≤1mg Qw); or GLP-1RA (maximum tolerated dose, ≤1mg Qw) combined with ≥1 OAD for ≥3 months; or Stable dose of ≥3 OADs (must include Metformin) for ≥3 months.
3. Fasting C-peptide ≥1.0 ng/mL.
4. Glutamic acid decarboxylase (GAD) antibody and Islet cell antibody (IAA) negative.
5. Body Mass Index (BMI) 18.5-35 kg/m ².
6. Subjects voluntarily participate in the study and sign the informed consent form.
7. Female subjects of childbearing potential and non-sterilized male subjects must agree to use highly effective contraceptive methods during the study period and for 1 year following the final infusion.
Exclusion Criteria:
1. Type 1 diabetes or other specific types of diabetes.
2. Occurrence of severe hypoglycemia or diabetic ketoacidosis within the past 6 months.
3. Severe cardiovascular/cerebrovascular diseases, hepatic or renal insufficiency (e.g., eGFR \<30 mL/min·1.73m²).
4. Active malignancy, coagulation disorders, immune system diseases.
5. Pregnant or lactating women.
6. Individuals with allergic constitution.
7. Exclusion of subjects currently participating in other clinical trials.
8. Subjects deemed unsuitable for participation by the investigator.
Primary outcome measure(s)
Change in Glycated Hemoglobin (HbA1c) — Baseline, Week 8 The primary efficacy endpoint is the change in glycated hemoglobin (HbA1c) from baseline to Week 8. In the randomized comparative stage, between-group differences between the investigational intervention group and the control group will also be evaluated.
Unit of Measure: Percentage (%)
Interpretation:
Reflects long-term glycemic control and overall metabolic efficacy of the intervention.
Trial sites (1)
Facility
City
Region
Status
Peking University first Hospital
Beijing
China
Recruiting
More Peking University First Hospital trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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