Type 2 Diabetes Mellitus (T2DM)Phase 1/2HOPE-T2DMNCT07693036
hUC-MSC-Exosomes for T2DM - Safety & Efficacy
A Phase 1/2 study testing exosomes treatment group in people with Type 2 Diabetes Mellitus (T2DM), run by Peking University First Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Type 2 Diabetes Mellitus (T2DM)
- What is being tested?
- exosomes treatment group
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- 1 siteChina
- Study dates
- 5 Jun 2026to 8 Jun 2028
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
- Exclusion of subjects currently participating in other clinical trials.
- Subjects deemed unsuitable for participation by the investigator.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Peking University first Hospital
Beijing
Yang Zhang, MD, 008613910670551, emilyzy14@sina.com
About this study
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
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.
Read the detailed description
A two-stage, progressive mixed design will be adopted to balance ethical considerations and scientific rigor.
Stage 1 (Open-Label, Before-and-After Study) will employ a sequential, open-label dose-escalation design:
A total of 18 patients will be enrolled, all receiving a 2-month course (once weekly, 8 doses total) of intravenous exosome infusion therapy. This study uses a sequential dose-escalation design with three dose cohorts: low-dose (1×10¹¹ particles), medium-dose (3×10¹¹ particles), and high-dose (9×10¹¹ particles). Dose escalation will strictly adhere to the following procedure:
Sequential Progression: The study for the next dose cohort can only commence after all subjects in the previous dose cohort have completed the required safety observation period (i.e., the 5-week follow-up post-last dose) and the safety data has been reviewed.
Stage 2 (Randomized, Double-Blind, Active-Comparator Parallel Study):
Provided no major safety issues are identified in the first stage, the second stage will commence. This stage plans to enroll 48 patients, randomized 2:1 to either the exosome treatment group (n=32) or the active-comparator control group (n=16).
Follow-up Plan: Multiple visits are scheduled, including a baseline period, treatment period (after each dose), end of treatment (Week 8/Month 2), and post-treatment follow-up periods (Week 12, Month 3, Month 6, Month 12), to systematically evaluate efficacy and safety.
- Conditions
- Type 2 Diabetes Mellitus (T2DM)
- Being tested
- exosomes treatment group, control group
- Keywords
- MSC-Exosomes, Exosomes, Type 2 Diabetes, Safety, Efficacy
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exosomes treatment groupBiological
Also called GoldenExo（NATX） treatment group
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 groupOther
Also called active-comparator
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)
| Study group | Role | What they receive |
|---|---|---|
| control group | Placebo comparator | Not described Receives: Other: control group |
| exosomes treatment group | Experimental | GoldenExo（NATX） treatment Receives: Biological: exosomes treatment group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, Week 8
Secondary outcomes (39)
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.
Measured: Week 24, Week 52
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).
Measured: Baseline, Week 4, Week 8，Week 12, Week 24, Week 52
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.
Measured: Baseline, Week 4, Week 8, Week 12, Week 24, Week 52
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.
Measured: Baseline, Week 8, Week 52
Anthropometric and Metabolic Parameters
Assessment of body composition and metabolic status. Body Mass Index (kg/m²)
Interpretation:
Reflects systemic metabolic control and cardiometabolic risk profile.
Measured: Baseline, Week 2, Week 4, Week 6, Week 8, Week 12, Week 24, Week 52
Soluble Adhesion Molecule (sICAM-1)
Serum levels of soluble intercellular adhesion molecule-1 (sICAM-1) as a marker of endothelial activation.
Unit of Measure: ng/mL
Interpretation:
Reflects endothelial dysfunction and vascular inflammatory activity.
Measured: Baseline, Week 4, Week 8, Week 12, Week 24, Week 52
Ophthalmologic Assessment
Assessment of diabetic retinopathy using fundus photography and standardized grading.
Unit of Measure: Clinical staging 5, listed below
Interpretation:
Reflects progression or stabilization of retinal microvascular disease.
- No apparent retinopathy / No diabetic retinopathy (No DR)
- Mild non-proliferative diabetic retinopathy (Mild NPDR)
- Moderate non-proliferative diabetic retinopathy (Moderate NPDR)
- Severe non-proliferative diabetic retinopathy (Severe NPDR)
- Proliferative diabetic retinopathy (PDR)
Measured: Baseline, Week 24
Change in Central Obesity: Waist-to-Hip Ratio (WHR)
Evaluation of changes in waist and hip circumferences to calculate the Waist-to-Hip Ratio (WHR), comparing baseline measurements with various post-treatment follow-up time points to quantify central obesity (visceral fat accumulation).
Unit of Measure:Centimeters (cm) for raw circumferences; Ratio is dimensionless. (Normal reference range: Male < 0.9, Female < 0.85) .
Interpretation:A classic anthropometric clinical index for assessing visceral adiposity. A decrease from baseline (negative change) indicates targeted reduction in abdominal fat and metabolic risk alleviation.
Measured: Baseline, Week 4, Week 8, Week 12, Week 24, Week 52
Body fat percentage (%)
Comparison of the body fat percentage between baseline and various post-treatment follow-up time points to evaluate quantitative and qualitative shifts in overall body composition. Normal reference range: Male （10%~20%）, Female （20%~30%） Unit of Measure:Percentage (%) Interpretation:Used to differentiate whether total body weight fluctuations stem from a true reduction in adipose tissue mass or the unintended, unorganized loss of lean muscle mass. A decrease from baseline (negative change) represents a favorable structural metabolic improvement.
Measured: Baseline, Week 8, Week 24, Week 52
C-Reactive Protein (CRP)
Description: Comparative monitoring of systemic immune cell populations (leukocyte subsets) and C-Reactive Protein (CRP) absolute concentrations between baseline and post-treatment points.
Unit of Measure:Milligrams per liter (mg/L) (Note: Units to be finalized based on specific laboratory assay methods and markers selected).
Interpretation:Tracks acute infectious episodes, systemic clinical flare-ups, or subclinical active inflammatory processes relative to baseline safety thresholds.
Measured: Baseline, Week 4, Week 8, Week 12, Week 24, Week 52
Time in Range (TIR, 3.9-10.0 mmol/L)
Description:
Continuous glucose monitoring (CGM) is used to assess 24-hour interstitial glucose dynamics Unit of Measure: % (TIR)
Interpretation:
Reflects short-term glycemic stability and variability control.
Measured: baseline to week 8
Mean glucose level
Description:
Continuous glucose monitoring (CGM) is used to assess 24-hour interstitial glucose dynamics Unit of Measure: mmol/L
Interpretation:
Reflects short-term glycemic stability and variability control.
Measured: baseline to week 8
Coefficient of variation (CV%)
Continuous glucose monitoring (CGM) is used to assess 24-hour interstitial glucose dynamics Unit of Measure: %
Interpretation:
Reflects short-term glycemic stability and variability control.
Measured: Baseline to week 8
Inflammatory Biomarkers：Interleukin-4 (IL-4)
A classic Th2-type anti-inflammatory cytokine modulating adaptive immune differentiation. Longitudinal alterations in serum IL-4 values will be evaluated using multiplex assays to assess Th2 immune response and inflammation alleviation effect.
Unit of Measurement: Picograms per milliliter (pg/mL) Clinical Significance: Moderate IL-4 expression balances Th1/Th2 immune axis and suppresses excessive pro-inflammatory reaction. Declined IL-4 level leads to immune imbalance and aggravated inflammatory progression.
Unit of Measure: pg/mL
Interpretation:
Reflects systemic low-grade inflammation and immune modulation.
Measured: Baseline, Week 4, Week 8, Week 12, Week 24, Week 52
Inflammatory Biomarkers：Interleukin-6（ IL-6）
A multifunctional pleiotropic pro-inflammatory cytokine linking innate and adaptive immunity. Longitudinal alterations in serum IL-6 values will be evaluated using multiplex assays to monitor dynamic systemic inflammatory fluctuation and therapeutic inflammatory improvement.
Unit of Measurement: Picograms per milliliter (pg/mL) Clinical Significance: Serum IL-6 concentration is positively correlated with the severity of systemic low-grade inflammation. Persistently elevated IL-6 facilitates inflammatory cell aggregation and chronic tissue pathological remodeling.
Measured: Baseline, Week 4, Week 8, Week 12, Week 24, Week 52
Inflammatory Biomarkers：Interleukin- 1β (IL-1β)
An early activated pro-inflammatory cytokine released by activated macrophages. Longitudinal alterations in serum IL-1β values will be evaluated using multiplex assays to assess the initiation degree of upstream inflammatory signaling pathways.
Unit of Measurement: Picograms per milliliter (pg/mL) Clinical Significance: Elevated IL-1β triggers downstream cascade inflammatory activation, induces systemic inflammatory pain and tissue degeneration, and indicates active early low-grade inflammatory stimulation.
Measured: Baseline, Week 4, Week 8, Week 12, Week 24, Week 52
Inflammatory Biomarkers：Interleukin-10 (IL-10)
A pivotal anti-inflammatory cytokine secreted mainly by regulatory T cells and macrophages. Longitudinal alterations in serum IL-10 values will be evaluated to assess endogenous anti-inflammatory capacity and intervention-induced immune negative regulation.
Unit of Measurement: Picograms per milliliter (pg/mL) Clinical Significance: Physiologically elevated IL-10 inhibits overactivated inflammatory cascade and reduces tissue inflammatory damage. Insufficient serum IL-10 expression breaks immune homeostasis, exacerbates systemic low-grade inflammation, and prolongs inflammatory pathological status.
Measured: Baseline, Week 4, Week 8, Week 12, Week 24, Week 52
Inflammatory Biomarkers：Interleukin-8 (IL-8)
A potent chemotactic pro-inflammatory cytokine targeting neutrophil migration. Longitudinal alterations in serum IL-8 values will be evaluated using multiplex assays to assess local and systemic inflammatory cell recruitment level.
Unit of Measurement: Picograms per milliliter (pg/mL) Clinical Significance: Increased IL-8 induces massive inflammatory cell infiltration into tissues, amplifies local inflammatory lesions, and maintains chronic persistent low-grade inflammatory status in vivo.
Measured: Baseline, Week 4, Week 8, Week 12, Week 24, Week 52
Inflammatory Biomarkers：Interleukin-2 (IL-2)
A key lymphocyte-derived pro-inflammatory cytokine regulating T-cell proliferation and activation. Longitudinal alterations in serum IL-2 values will be evaluated using multiplex assays to assess peripheral T lymphocyte immune activation status.
Unit of Measurement: Picograms per milliliter (pg/mL) Clinical Significance: Abnormally elevated IL-2 mediates excessive effector T-cell activation, enhances inflammatory immune attack, and participates in the occurrence and development of immune-mediated inflammatory lesions
Measured: Baseline, Week 4, Week 8, Week 12, Week 24, Week 52
Inflammatory Biomarkers：Tumor Necrosis Factor-alpha (TNF-α)
A core pro-inflammatory cytokine derived from monocytes and macrophages. Longitudinal alterations in serum TNF-α values will be evaluated using multiplex assays to assess systemic inflammatory activation degree and inflammatory injury level.
Unit of Measurement: Picograms per milliliter (pg/mL) Clinical Significance: Sustained high serum TNF-α level drives persistent systemic low-grade inflammation, induces cellular apoptosis and visceral tissue damage, and acts as a key biomarker reflecting chronic inflammatory disease activity.
Measured: Baseline, Week 4, Week 8, Week 12, Week 24, Week 52
Inflammatory Biomarkers：Interferon-gamma (IFN-γ)
A typical type 1 pro-inflammatory cytokine produced by T lymphocytes and natural killer cells. Longitudinal alterations in serum IFN-γ values will be evaluated using multiplex assays to assess cellular immune activation and pro-inflammatory immune polarization.
Unit of Measurement: Picograms per milliliter (pg/mL) Clinical Significance: Excess IFN-γ triggers Th1-type immune hyperactivation, promotes inflammatory cell infiltration, aggravates autoimmune and inflammatory responses, and predicts poor immune regulatory status.
Measured: Baseline, Week 4, Week 8, Week 12, Week 24, Week 52
Inflammatory Biomarkers：Interferon-alpha (IFN-α)
An innate immune-derived pro-inflammatory interferon primarily secreted by plasmacytoid dendritic cells. Longitudinal alterations in serum IFN-α values will be evaluated using multiplex assays to assess innate immune activation and early inflammatory response.
Unit of Measurement: Picograms per milliliter (pg/mL) Clinical Significance: Upregulated IFN-α activates innate immune cascade reaction, induces systemic inflammatory cascade, and is closely associated with chronic low-grade inflammation and immune overreaction.
Measured: Baseline, Week 4, Week 8, Week 12, Week 24, Week 52
Inflammatory Biomarkers： Interleukin-17A（IL-17A）
A signature pro-inflammatory cytokine secreted by Th17 cells. Longitudinal alterations in serum IL-17A values will be evaluated using multiplex assays to assess Th17-mediated inflammatory response and mucosal inflammatory injury.
Unit of Measurement: Picograms per milliliter (pg/mL) Clinical Significance: High-level IL-17A breaks immune tolerance, promotes pro-inflammatory mediator release, and is a core biomarker for aggravated chronic inflammatory and autoimmune pathological changes.
Measured: Baseline, Week 4, Week 8, Week 12, Week 24, Week 52
Inflammatory Biomarkers：Interleukin-12p70 (IL-12p70)
A heterodimeric pro-inflammatory cytokine driving Th1 cell differentiation. Longitudinal alterations in serum IL-12p70 values will be evaluated using multiplex assays to assess Th1 immune axis differentiation bias.
Unit of Measurement: Picograms per milliliter (pg/mL) Clinical Significance: Upregulated IL-12p70 polarizes immune response toward pro-inflammatory Th1 phenotype, amplifies cellular inflammatory immunity, and worsens systemic inflammatory imbalance.
Measured: Baseline, Week 4, Week 8, Week 12, Week 24, Week 52
Inflammatory Biomarkers：Interleukin-5 (IL-5)
A Th2-derived anti-inflammatory regulatory cytokine modulating eosinophil activity. Longitudinal alterations in serum IL-5 values will be evaluated using multiplex assays to assess type 2 immune regulation and inflammatory remission trend.
Unit of Measurement: Picograms per milliliter (pg/mL) Clinical Significance: Physiological IL-5 assists immune homeostasis maintenance and antagonizes excessive pro-inflammatory responses. Dysregulated IL-5 expression disrupts overall anti-inflammatory immune compensation in the body.
Measured: Baseline, Week 4, Week 8, Week 12, Week 24, Week 52
High-Density Lipoprotein Cholesterol (HDL-C)
Apolipoprotein A-I (ApoA-I) serves as its primary apolipoprotein. Longitudinal alterations in HDL-C values from baseline to each post-treatment follow-up time point will be evaluated to assess the modulation of lipid metabolism.
Unit of Measurement: Millimoles per liter (mmol/L) Clinical Significance: Within the physiological range, higher concentrations are clinically desirable. Conversely, a significantly reduced level (< 1.0 mmol/L) impairs the reverse cholesterol transport pathway, leading to a corresponding increase in cardiovascular and cerebrovascular risks.
Measured: Baseline, Week 4, Week 8, Week 12, Week 24, Week 52
Low-Density Lipoprotein Cholesterol (LDL-C)
Its primary pathophysiological function is to transport endogenous cholesterol from the liver to peripheral arterial walls. Variations from baseline to subsequent follow-up intervals will be analyzed to evaluate the systemic lipid metabolic profile.
Unit of Measurement: Millimoles per liter (mmol/L) Clinical Significance: LDL-C is established as the primary target for clinical lipid-lowering therapeutic interventions. Elevated levels accelerate cholesterol infiltration into the subendothelial space, driving atheromatous plaque formation and substantially escalating the risk of acute myocardial infarction and ischemic stroke.
Measured: Baseline, Week 4, Week 8, Week 12, Week 24, Week 52
Total Cholesterol (TC)
Description: TC represents the quantified sum of cholesterol contained within all circulating lipoprotein fractions. The numerical shifts between baseline and post-treatment follow-up points will be utilized to gauge the overall regulation of lipid homeostasis.
Unit of Measurement: Millimoles per liter (mmol/L) Clinical Significance: TC serves as a fundamental screening biomarker for macroeconomic cardiovascular risk assessment. A longitudinal reduction in TC levels relative to baseline denotes a favorable optimization of systemic lipid metabolism and a subsequent decrease in cardiovascular risk.
Measured: Baseline, Week 4, Week 8, Week 12, Week 24, Week 52
Triglycerides (TG)
Description: TG is derived primarily from exogenous dietary intake and endogenous hepatic synthesis. Post-treatment variations relative to baseline will be monitored across all specified follow-up time points to assess systemic lipid metabolic homeostasis.
Unit of Measurement: Millimoles per liter (mmol/L) Clinical Significance: A downward shift or a stabilized reduction from baseline values reflects a clinically meaningful improvement in systemic lipid metabolic status and a mitigation of metabolic syndrome severity.
Measured: Baseline, Week 4, Week 8, Week 12, Week 24, Week 52
Hepatic Fibrosis (LSM)
Liver stiffness is assessed using ultrasound elastography. Liver stiffness measurement (LSM) reflects the degree of hepatic fibrotic remodeling.
Unit of Measure: kPa Interpretation: Higher LSM values indicate more advanced liver fibrosis.
Measured: Baseline, week 24
Hepatic Steatosis (CAP)
Liver fat content is assessed using ultrasound elastography. The Controlled Attenuation Parameter (CAP) reflects the degree of hepatic steatosis.
Unit of Measure: dB/m Interpretation: Higher CAP values indicate greater hepatic fat accumulation.
Measured: Baseline, week 24
Carotid Atherosclerosis Assessment: Plaque Size
High-resolution vessel wall magnetic resonance imaging (HR-VWMRI) will be utilized to perform quantitative assessments of the target vascular plaque. Longitudinal variations in plaque metrics will be analyzed by evaluating the structural changes from baseline to each post-treatment follow-up time point.
Unit of Measurement: Millimeters (mm) Clinical Significance: A statistically significant reduction in plaque dimensions relative to baseline values serves as an objective indicator of plaque regression or reversal. This morphological regression (or reduction) denotes a favorable therapeutic response, an optimization of the local vascular microenvironment, and a subsequent mitigation of the overall vascular burden.
Measured: Baseline, Week 24,
Carotid Atherosclerosis Assessment: Comparison of bilateral Carotid Intima-Media Thickness (CIMT)
Objectively evaluates macrovascular structural remodelling, atheromatous burden, and the progression or regression of systemic macrovascular sclerosis beyond isolated glycemic control.
Unit of Measurement: Millimeters (mm)
Measured: Baseline, Week 24,
Urine Albumin-to-Creatinine Ratio (UACR)
Urine albumin-to-creatinine ratio (UACR) is a sensitive marker of early renal injury and a key indicator for diabetic kidney disease screening and progression monitoring. UACR is measured from spot urine samples (first-morning void preferred). Changes in UACR from baseline reflect the impact of the intervention on renal microvascular function Unit of Measure: mg/g Interpretation: Higher UACR values indicate greater urinary albumin excretion, reflecting more advanced renal damage.
Measured: Baseline, Week 8, Week 24
Changes in Insulin Secretion during MMTT
Fasting (0 min) and 2-hour postprandial (120 min) insulin 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: μIU/mL Interpretation: Enhanced postprandial insulin secretion indicates improved β-cell secretory function.
Measured: Baseline, Week 8, Week 52
Changes in C-peptide Levels during MMTT
Fasting (0 min) and 2-hour postprandial (120 min) C-peptide levels are measured during mixed-meal tolerance test (MMTT). Changes from baseline at various post-treatment follow-up time points are compared. C-peptide is a more stable indicator of endogenous insulin secretion than insulin itself.
Unit of Measure: ng/mL Interpretation: Increased postprandial C-peptide levels indicate preserved or improved endogenous β-cell function.
Measured: Baseline, Week 8, Week 52
Change in Homeostatic Model Assessment for Insulin Resistance (HOMA-IR)
HOMA-IR is calculated from fasting blood glucose and fasting insulin (or fasting C-peptide as an alternative if patients are on an insulin regimen) to assess changes in insulin resistance from baseline to post-treatment follow-up time points.
Unit of Measure: Score on a scale (unitless) Interpretation: A lower HOMA-IR value indicates improved insulin sensitivity.
Measured: Baseline, Week 8, Week 52
Change in Homeostatic Model Assessment for β-cell Function (HOMA-β)
HOMA-β is calculated from fasting blood glucose and fasting insulin (or fasting C-peptide as an alternative if patients are on an insulin regimen) to assess changes in pancreatic β-cell function from baseline to post-treatment follow-up time points.
Unit of Measure: Percentage (%) Interpretation: A higher HOMA-β value indicates improved β-cell function.
Measured: Baseline, Week 8, Week 52
Diabetes Specific Quality of Life (DSQL)
Diabetes Specific Quality of Life Scale (DSQL) is a validated questionnaire assessing quality of life in patients with diabetes mellitus. The scale evaluates four domains: physiological function, psychological/spiritual, social relations, and treatment effects. Higher scores indicate poorer quality of life. DSQL is widely used in Chinese diabetic populations and has demonstrated good reliability and validity. The total score will be analyzed.
Unit of Measure：Score on a scale Interpretation: Higher scores indicate poorer quality of life.
Measured: Baseline, Week 8, Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2026
- Study start5 Jun 2026
- Primary completion4 Jun 2028 (estimated)
- Study completion8 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes Mellitus (T2DM)Studies of the same condition, open and under way.
- More trials run by Peking University First HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Model Description
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University First Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- ECHO Biotech
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07693036
- Sponsor's protocol ID
- 2026R0184-0002
- Acronym
- HOPE-T2DM
- Status last verified
- Apr 2026
- First submitted
- 8 Jun 2026
- Last updated
- 9 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07693036
- Acronym / sponsor ID
- HOPE-T2DM / 2026R0184-0002
- Conditions
- Type 2 Diabetes Mellitus (T2DM)
- Keywords
- MSC-Exosomes, Exosomes, Type 2 Diabetes, Safety, Efficacy
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Peking University First HospitalUniversity, hospital or other
- Collaborators
- ECHO Biotech
- Study start
- 5 Jun 2026 (actual)
- Primary completion
- 4 Jun 2028 (estimated)
- Study completion
- 8 Jun 2028 (estimated)
- First posted
- 9 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
A two-stage, progressive mixed design will be adopted to balance ethical considerations and scientific rigor.
Stage 1 (Open-Label, Before-and-After Study) will employ a sequential, open-label dose-escalation design:
A total of 18 patients will be enrolled, all receiving a 2-month course (once weekly, 8 doses total) of intravenous exosome infusion therapy. This study uses a sequential dose-escalation design with three dose cohorts: low-dose (1×10¹¹ particles), medium-dose (3×10¹¹ particles), and high-dose (9×10¹¹ particles). Dose escalation will strictly adhere to the following procedure:
Sequential Progression: The study for the next dose cohort can only commence after all subjects in the previous dose cohort have completed the required safety observation period (i.e., the 5-week follow-up post-last dose) and the safety data has been reviewed.
Stage 2 (Randomized, Double-Blind, Active-Comparator Parallel Study):
Provided no major safety issues are identified in the first stage, the second stage will commence. This stage plans to enroll 48 patients, randomized 2:1 to either the exosome treatment group (n=32) or the active-comparator control group (n=16).
Follow-up Plan: Multiple visits are scheduled, including a baseline period, treatment period (after each dose), end of treatment (Week 8/Month 2), and post-treatment follow-up periods (Week 12, Month 3, Month 6, Month 12), to systematically evaluate efficacy and safety.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Model Description
| Arm | Type | Receives |
|---|---|---|
| control group | Placebo comparator | Other: control group |
| exosomes treatment group | Experimental | Biological: exosomes treatment groupGoldenExo（NATX） treatment |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| exosomes treatment groupAlso: GoldenExo（NATX） treatment groupGoldenExo（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). | Biological | exosomes treatment group |
| control groupAlso: active-comparatoractive-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) | Other | control group |
Primary outcome
Change in Glycated Hemoglobin (HbA1c)
Time frame: Baseline, Week 8
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.
39 secondary outcomes
Glycated Hemoglobin (HbA1c) Response Rate
Time frame: Week 24, Week 52
Pancreatic Islet Function: Insulin (INS)
Time frame: Baseline, Week 4, Week 8，Week 12, Week 24, Week 52
Pancreatic Islet Function: C-peptide
Time frame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 52
Changes in Blood Glucose during MMTT
Time frame: Baseline, Week 8, Week 52
Anthropometric and Metabolic Parameters
Time frame: Baseline, Week 2, Week 4, Week 6, Week 8, Week 12, Week 24, Week 52
Soluble Adhesion Molecule (sICAM-1)
Time frame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 52
Ophthalmologic Assessment
Time frame: Baseline, Week 24
Change in Central Obesity: Waist-to-Hip Ratio (WHR)
Time frame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 52
Body fat percentage (%)
Time frame: Baseline, Week 8, Week 24, Week 52
C-Reactive Protein (CRP)
Time frame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 52
Time in Range (TIR, 3.9-10.0 mmol/L)
Time frame: baseline to week 8
Mean glucose level
Time frame: baseline to week 8
Coefficient of variation (CV%)
Time frame: Baseline to week 8
Inflammatory Biomarkers：Interleukin-4 (IL-4)
Time frame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 52
Inflammatory Biomarkers：Interleukin-6（ IL-6）
Time frame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 52
Inflammatory Biomarkers：Interleukin- 1β (IL-1β)
Time frame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 52
Inflammatory Biomarkers：Interleukin-10 (IL-10)
Time frame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 52
Inflammatory Biomarkers：Interleukin-8 (IL-8)
Time frame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 52
Inflammatory Biomarkers：Interleukin-2 (IL-2)
Time frame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 52
Inflammatory Biomarkers：Tumor Necrosis Factor-alpha (TNF-α)
Time frame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 52
Inflammatory Biomarkers：Interferon-gamma (IFN-γ)
Time frame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 52
Inflammatory Biomarkers：Interferon-alpha (IFN-α)
Time frame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 52
Inflammatory Biomarkers： Interleukin-17A（IL-17A）
Time frame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 52
Inflammatory Biomarkers：Interleukin-12p70 (IL-12p70)
Time frame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 52
Inflammatory Biomarkers：Interleukin-5 (IL-5)
Time frame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 52
High-Density Lipoprotein Cholesterol (HDL-C)
Time frame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 52
Low-Density Lipoprotein Cholesterol (LDL-C)
Time frame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 52
Total Cholesterol (TC)
Time frame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 52
Triglycerides (TG)
Time frame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 52
Hepatic Fibrosis (LSM)
Time frame: Baseline, week 24
Hepatic Steatosis (CAP)
Time frame: Baseline, week 24
Carotid Atherosclerosis Assessment: Plaque Size
Time frame: Baseline, Week 24,
Carotid Atherosclerosis Assessment: Comparison of bilateral Carotid Intima-Media Thickness (CIMT)
Time frame: Baseline, Week 24,
Urine Albumin-to-Creatinine Ratio (UACR)
Time frame: Baseline, Week 8, Week 24
Changes in Insulin Secretion during MMTT
Time frame: Baseline, Week 8, Week 52
Changes in C-peptide Levels during MMTT
Time frame: Baseline, Week 8, Week 52
Change in Homeostatic Model Assessment for Insulin Resistance (HOMA-IR)
Time frame: Baseline, Week 8, Week 52
Change in Homeostatic Model Assessment for β-cell Function (HOMA-β)
Time frame: Baseline, Week 8, Week 52
Diabetes Specific Quality of Life (DSQL)
Time frame: Baseline, Week 8, Week 52
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing exosomes treatment group in people with Type 2 Diabetes Mellitus (T2DM), run by Peking University First Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yang Zhang (+8613910670551, emilyzy14@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Glycated Hemoglobin (HbA1c) (time frame: Baseline, Week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2026.