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Clinical trial Recruiting at 1 site Phase1; Phase2 Interventional Ages 18 to 65

hUC-MSC-Exosomes for Type 2 Diabetes: Safety and Early Effect

Official title: 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

Run by Peking University First Hospital · NCT07693036 · Data updated 2026-11-12

This study tests whether intravenous exosomes derived from human umbilical cord mesenchymal stem cells are safe and show early signs of benefit in adults with Type 2 diabetes.

Quick facts

PhasePhase1; Phase2
Study typeInterventional
Ages18 Years to 65 Years
SexAll
Enrollment66 (estimated)
SponsorPeking University First Hospital
Academic / other
Locations1 site (Beijing)
StatusRecruiting
StartedJune 5, 2026
Main results expectedJune 4, 2028
Study endsJune 8, 2028
Registry record updatedJuly 9, 2026
Trial IDNCT07693036 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults aged 18–65 with Type 2 diabetes of at least 5 years who are on stable, intensive therapy and meet the specified HbA1c and C-peptide criteria.

Probably not a fit

Patients with advanced diabetes complications, poor renal/hepatic function, or failing to meet the inclusion criteria may not benefit from this approach.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a two-stage, mixed-design trial. Stage 1 is open-label and dose-escalating, enrolling 18 participants to receive eight weekly exosome infusions over two months, in three dose cohorts. Stage 2, if Stage 1 is safe, will randomize 48 participants in a 2:1 ratio to exosome treatment or an active comparator, with follow-up through 12 months to evaluate safety and preliminary efficacy. The study uses a sequential progression trigger based on safety reviews before escalating doses. Primary endpoints focus on safety, with secondary endpoints exploring early efficacy signals in glycemic control and related metabolic parameters.

Why it matters

Potential benefit: If successful, the treatment could offer a new, biologically based approach to improve glucose control in adults with T2DM.

How similar studies have gone: Previous work in cell-derived exosomes for metabolic conditions has shown safety signals and potential metabolic effects in early-phase studies, but the approach remains exploratory for diabetes.

Who can join: the full rules

Show full inclusion / exclusion 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.

Where it's running

  • Peking University first Hospital
    Beijing, China     Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
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Type 2 Diabetes Mellitus (T2DM) 68Peking University First Hospital 99
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.