hUC-MSC-Exosomes for T2DM - Safety & Efficacy

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

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.

Conditions2

Interventions1

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