Stem Cell-Derived Exosomes for Adults With Type 2 Diabetes
Tests exosomes from umbilical cord stem cells in adults with type 2 diabetes.
Plain-language title generated from the registry record
Registry title: hUC-MSC-Exosomes for T2DM - Safety & Efficacy
Key facts
- Where
- Beijing, ChinaSee the site
- Phase
- Phase 1/2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 65 years old?
Source: NCT07693036, who can take part
Where in China
- Peking University First HospitalBeijing, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Peking University First Hospital
- Trial code
- NCT07693036
- Record updated
- 9 July 2026
- Original description
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.Read full original descriptionShow less
An Exploratory Clinical Study Assessing the Safety and Preliminary Efficacy of Human Umbilical Cord Mesenchymal Stem Cell-Derived Exosomes in the Treatment of Adult Type 2 Diabetes Mellitus
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.
Inclusion: 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.
Exclusion: Type 1 diabetes or other specific types of diabetes; Active malignancy, coagulation disorders, immune system diseases; Individuals with allergic constitution; Severe cardiovascular/cerebrovascular diseases, hepatic or renal insufficiency (e.g., eGFR <30 mL/min·1.73m²); Occurrence of severe hypoglycemia or diabetic ketoacidosis within the past 6 months; Pregnant or lactating women; Exclusion of subjects currently participating in other clinical trials; Subjects deemed unsuitable for participation by the investigator.