hUC-MSC-Exosomes for T2DM - Safety & Efficacy

Recruiting now · Phase 1/Phase 2

Conditions studied: Type 2 Diabetes Mellitus (T2DM)

In brief

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.

Key facts

Study ID

NCT07693036

Run by

Peking University First Hospital

People needed

66

Starts

2026-06-05

Expected to finish

2028-06-08

Last updated by the study team

2026-07-09

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age 18-65 years, diagnosed with T2DM for ≥5 years (<20 years).
• 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.
• Fasting C-peptide ≥1.0 ng/mL.
• Glutamic acid decarboxylase (GAD) antibody and Islet cell antibody (IAA) negative.
• Body Mass Index (BMI) 18.5-35 kg/m ².
• Subjects voluntarily participate in the study and sign the informed consent form.
• 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.

You may not qualify if…

• Type 1 diabetes or other specific types of diabetes.
• Occurrence of severe hypoglycemia or diabetic ketoacidosis within the past 6 months.
• Severe cardiovascular/cerebrovascular diseases, hepatic or renal insufficiency (e.g., eGFR <30 mL/min·1.73m²).
• Active malignancy, coagulation disorders, immune system diseases.
• Pregnant or lactating women.
• Individuals with allergic constitution.
• Exclusion of subjects currently participating in other clinical trials.
• Subjects deemed unsuitable for participation by the investigator.

Where it is running

• Peking University first Hospital — Beijing, China (enrolling)

Full record on ClinicalTrials.gov

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