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Tests treatment safety and results for Type 2 Diabetes Mellitus (T2DM)
Official title hUC-MSC-Exosomes for T2DM - Safety & Efficacy
ClinicalTrials.gov ID: NCT07693036
What this study is testing
What is exosomes treatment group?
exosomes treatment group is an investigational medicine, given as an once-weekly infusion into a vein, being studied as a potential treatment for type 2 diabetes mellitus (t2dm).
Also referred to as GoldenExo（NATX） treatment group.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join 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...
- 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.
You likely can't join 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.
See the full eligibility criteria
- 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...
- 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.
- people voluntarily participate in the study and sign the informed consent form.
- Female people of childbearing potential and non-sterilized male people must agree to use highly effective contraceptive methods during the study period and for 1 year following the final infusion.
- 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 people currently participating in other clinical trials.
- people deemed unsuitable for participation by the investigator.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.