hUC-MSC-Exosomes for T2DM - Safety & Efficacy

NCT07693036 | Recruiting Phase 1 DMC

• 1 other identifier: 2026R0184-0002
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes Mellitus (T2DM)

Keywords

MSC-Exosomes; Exosomes; Type 2 Diabetes; Safety; Efficacy

Outcome Measures

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.

  Baseline, Week 8

Secondary Outcomes (39)

• Glycated Hemoglobin (HbA1c) Response Rate

  Week 24, Week 52

• Pancreatic Islet Function: Insulin (INS)

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

• Pancreatic Islet Function: C-peptide

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

• Changes in Blood Glucose during MMTT

  Baseline, Week 8, Week 52

• Anthropometric and Metabolic Parameters

  Baseline, Week 2, Week 4, Week 6, Week 8, Week 12, Week 24, Week 52

Study Arms (2)

control group

PLACEBO COMPARATOR

Other: control group

exosomes treatment group

EXPERIMENTAL

GoldenExo（NATX） treatment

Biological: exosomes treatment group

Interventions

exosomes treatment group BIOLOGICAL

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).

Also known as: GoldenExo（NATX） treatment group

exosomes treatment group

control group OTHER

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)

Also known as: active-comparator

control group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Pregnant or lactating women.
• Individuals with allergic constitution.
• Subjects deemed unsuitable for participation by the investigator.

Sponsors & Collaborators

• ECHO Biotech: collaborator
• Peking University First Hospital: lead

Study Sites (1)

Peking University first Hospital

Beijing, China

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Central Study Contacts

Yang Zhang

CONTACT

+8613910670551; emilyzy14@sina.com

Pei Heng Zhang

CONTACT

+8617710937961; zhangpeiheng2021@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Masking Description
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Model Description

Study Record Dates

• First Submitted: June 8, 2026
• First Posted: July 9, 2026
• Study Start: June 5, 2026
• Primary Completion (Estimated): June 4, 2028
• Study Completion (Estimated): June 8, 2028
• Last Updated: July 9, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)