Health TrialsbyHealthPanel

hUC-MSC-Exosomes for T2DM - Safety & Efficacy

ConditionType 2 Diabetes Mellitus (T2DM)
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorPeking University First Hospital

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • exosomes treatment group

    Biological/Vaccine

    GoldenExo（NATX） treatment group (n=32) The specific therapeutic dose for the second stage will be evaluated and determined jointly by the investigators and the Safety Monitoring Committee (SMC) after all three dose escalation trials (1×10¹¹, 3×10¹¹, 9×10¹¹ particles) in the first stage.Subjects in both groups will receive intravenous infusions once weekly for 8 weeks (a total of 8 doses).

  • control group

    Other intervention

    active-comparator control：（n=16）The control group will receive an equal volume of the same buffer solution without exosomes (.Subjects in this groups will receive intravenous infusions once weekly for 8 weeks (a total of 8 doses)

Treatment groups

66 Participants
are divided into 2 treatment groups
Group A: control groupPlacebo comparator 1 intervention
Group B: exosomes treatment groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Change in Glycated Hemoglobin (HbA1c)

The primary efficacy endpoint is the change in glycated hemoglobin (HbA1c) from baseline to Week 8. In the randomized comparative stage, between-group differences between the investigational intervention group and the control group will also be evaluated. Unit of Measure: Percentage (%) Interpretation: Reflects long-term glycemic control and overall metabolic efficacy of the intervention.

Time frame
Baseline, Week 8

Secondary outcomes

1

Glycated Hemoglobin (HbA1c) Response Rate

Proportion of participants achieving HbA1c target control. Definition: HbA1c \< 7.0% Unit of Measure: Percentage of participants (%) Interpretation: Reflects long-term glycemic target attainment rate.

Time frame
Week 24, Week 52
2

Pancreatic Islet Function: Insulin (INS)

Comparison of serum/plasma insulin levels between baseline and various post-treatment follow-up time points via synchronous venous blood sampling at fasting. Unit of Measure:Picomoles per liter (pmol/L). Interpretation:Used to evaluate circulating insulin levels. HOMA-IR assesses the sensitivity of peripheral target tissues (skeletal muscle, liver, adipose tissue) to insulin, where higher values indicate more severe resistance. HOMA-beta statically evaluates baseline pancreatic beta-cell secretory function under fasting conditions (applicable to subjects not receiving exogenous insulin therapy).

Time frame
Baseline, Week 4, Week 8，Week 12, Week 24, Week 52
3

Pancreatic Islet Function: C-peptide

Comparison of serum/plasma C-peptide levels between baseline and various post-treatment follow-up time points, measured synchronously from venous blood at fasting. Unit of Measure:Nanograms per milliliter (ng/mL) Interpretation:Used to evaluate endogenous insulin secretion. Because C-peptide bypasses hepatic first-pass metabolism, it precisely mirrors true residual endogenous pancreatic beta-cell mass and functional capacity. An increase from baseline (positive change) indicates functional recovery or preservation of pancreatic beta-cells.

Time frame
Baseline, Week 4, Week 8, Week 12, Week 24, Week 52
4

Changes in Blood Glucose during MMTT

Fasting (0 min) and 2-hour postprandial (120 min) blood glucose levels are measured during mixed-meal tolerance test (MMTT). Changes from baseline at various post-treatment follow-up time points are compared. Unit of Measure: mmol/L Interpretation: Lower postprandial glucose levels and/or reduced glucose excursion during MMTT indicate improved glycemic control and β-cell function.

Time frame
Baseline, Week 8, Week 52

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Peking University First Hospital

Lead sponsor

ECHO Biotech

Collaborator

Source ClinicalTrials.gov
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