Mesenchymal Stem Cells to Treat Type 2 Diabetes (UC-MSCs)

Chinese PLA General Hospital (301 Hospital)

Status and phase: Completed; Phase 2

Conditions: Mesenchymal Stem Cells; Type 2 Diabetes

Treatments: Biological: Umbilical cord mesenchymal stem cells; Biological: Controlled suspension liquid

Study type: Interventional

Funder types: Other

Identifiers

NCT02302599

CHIN-PLAGH-ST-003

Details and patient eligibility

About

Umbilical cord mesenchymal stem cells indicate the therapeutic effects and safety on type 2 diabetes by characteristics of secretion and immune Immunomodulation.

Full 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.

Enrollment: 103 patients

Sex: All

Ages: 20 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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103 participants in 2 patient groups

Umbilical cord mesenchymal stem cells

Experimental group

Description:

Patients receive Umbilical cord mesenchymal stem cells intravenous infusion for three times with an interval of 4 weeks in the absence of disease progression or unacceptable toxicity

Treatment:

Biological: Umbilical cord mesenchymal stem cells

Controlled suspension liquid

Experimental group

Description:

Patients receive Controlled suspension liquid

Treatment:

Biological: Controlled suspension liquid