NCT07693036RecruitingPhase 1/2
hUC-MSC-Exosomes for T2DM - Safety & Efficacy
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
Source: ClinicalTrials.gov · Last updated 9 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 66 (estimated)
- First submitted
- 8 Jun 2026
- Start date
- 5 Jun 2026
- Primary completion date
- 4 Jun 2028
- Lead sponsor
- Peking University First Hospital
- Diseases
- Type 2 diabetes
- NCT number
- NCT07693036
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 66
- From 5 Jun 2026 to the primary completion date, 4 Jun 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Type 1 diabetes or other specific types of diabetes.
- Active malignancy, coagulation disorders, immune system diseases.
- Individuals with allergic constitution.
Lab values
- Severe cardiovascular/cerebrovascular diseases, hepatic or renal insufficiency (e.g., eGFR \<30 mL/min·1.73m²).
Other
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Peking University First Hospital Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.