Mesenchymal Stem Cells, Type 2 Diabetes
Conditions
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 state of diabetes by secreting a variety of cytokines. It can induce damaged alpha cells differentiate into beta cells in the islet transformation to realize the islet beta cells in situ regeneration by improving microenvironment of islet beta cells. Umbilical cord mesenchymal stem cells also have immunosuppressive effect, it can promote islet cell repair and regeneration by the inhibition of T cell mediated immune response to beta cells.
Interventions
BIOLOGICALUmbilical cord mesenchymal stem cells
Infusion treatment
BIOLOGICALControlled suspension liquid
Infusion treatment
Sponsors
Chinese PLA General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
All investigators and participants were masked to treatment allocation. The independent data monitoring committee and the statisticians supporting the committee's activities were the only people with access to unblinded data.
Intervention model description
UC-MSCs (1.5×106/kg) or the same volume of placebo (suspension liquid without UC-MSCs)
Eligibility
Sex/Gender
ALL
Age
20 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. 20 ≤ age ≤ 65 years; 2. Duration of type 2 diabetes ≤20 years; 3. 24.0 kg/m2 ≤ BMI ≤40.0 kg/m2; 4. 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; 5. 7.0% ≤ HbA1c ≤ 12.0%; 6. Fasting C-peptide ≥ 1ng/ml; 7. Willingness to participate in the trial.
Exclusion criteria
1. 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; 2. Severe concurrent illness limiting life expectancy, inadequate understanding of the study protocol, drug abuse, pregnant willing and allergic constitution.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The efficacy of umbilical cord mesenchymal stem cells in Chinese adults with T2D | 48 weeks from baseline | proportion of patients with HbA1c \<7.0% and daily insulin reduction ≥50% from baseline to 48 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Other efficacy parameter of umbilical-cord mesenchymal stem cells in Chinese adults with T2D | 48 weeks from baseline | Changes of insulin requirement, HbA1c and proportion of patients reaching the HbA1c target (\<7.0%) |
| safety parameter of umbilical-cord mesenchymal stem cells in Chinese adults with T2D | 48 weeks from baseline | Fever, pruritus, nausea and vomiting, anaphylactic shock, phlebitis，tumor formation, infection, impaired liver and kidney function. |
Countries
China
Outcome results
None listed