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
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
Treatments tested in this trial
- exosomes treatment group
- control group
Treatment groups
66 Participants
are divided into 2 treatment groupsSponsors and collaborators
Peking University First Hospital
Lead sponsor
ECHO Biotech
Collaborator
Source ClinicalTrials.gov