Status:
COMPLETED
Mesenchymal Stem Cells to Treat Type 2 Diabetes
Lead Sponsor:
Chinese PLA General Hospital
Conditions:
Type 2 Diabetes
Mesenchymal Stem Cells
Eligibility:
All Genders
20-65 years
Phase:
PHASE2
Brief Summary
Umbilical cord mesenchymal stem cells indicate the therapeutic effects and safety on type 2 diabetes by characteristics of secretion and immune Immunomodulation.
Detailed Description
Umbilical cord mesenchymal stem cells can improve insulin resistance of the target tissues, reduce the islet progressive damage, ease or regenerate of the islet beta cells and improve hyperglycemic st...
Eligibility Criteria
Inclusion
- 20 ≤ age ≤ 65 years;
- Duration of type 2 diabetes ≤20 years;
- 24.0 kg/m2 ≤ BMI ≤40.0 kg/m2;
- Stable exogenous insulin dose between 0.5-1.0 U/Kg/Day with or without oral hypoglycemic agents (Dipeptidyl peptidase-4 (DPP-4) inhibitor, Glucagon like peptide 1 receptor (GLP-1R) agonist and Sodium-glucose co-transporter 2 (SGLT-2) inhibitor excluded) for at least 3 months;
- 7.0% ≤ HbA1c ≤ 12.0%;
- Fasting C-peptide ≥ 1ng/ml;
- Willingness to participate in the trial.
Exclusion
- Patients with ketonuria, tumor, serum creatinine level more than 175μmol/L, myocardial infarction in the previous year, current angina or heart failure, more than one major vascular event, retinopathy requiring laser treatment, malignant hypertension, uncorrected endocrine disorder, occupations precluding insulin therapy;
- Severe concurrent illness limiting life expectancy, inadequate understanding of the study protocol, drug abuse, pregnant willing and allergic constitution.
Key Trial Info
Start Date :
January 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2020
Estimated Enrollment :
103 Patients enrolled
Trial Details
Trial ID
NCT02302599
Start Date
January 1 2013
End Date
December 1 2020
Last Update
February 3 2021
Active Locations (1)
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1
Chinese PLA General Hospital
Beijing, Beijing Municipality, China, 100039