NCT07693036 hUC-MSC-Exosomes for T2DM - Safety & Efficacy
| NCT ID | NCT07693036 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Peking University First Hospital |
| Condition | Type 2 Diabetes Mellitus (T2DM) |
| Study Type | INTERVENTIONAL |
| Enrollment | 66 participants |
| Start Date | 2026-06-05 |
| Primary Completion | 2028-06-04 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 66 participants in total. It began in 2026-06-05 with a primary completion date of 2028-06-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07693036 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Type 2 Diabetes Mellitus (T2DM). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07693036 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07693036 currently recruiting?
Yes, NCT07693036 is actively recruiting participants. Contact the research team at emilyzy14@sina.com for enrollment information.
Where is the NCT07693036 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT07693036 clinical trial?
NCT07693036 is sponsored by Peking University First Hospital. The trial plans to enroll 66 participants.
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