Mesenchymal Stem Cells to Treat Type 2 Diabetes

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

Detailed Description
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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.

Official Title
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Efficacy and Safety of Umbilical-cord Mesenchymal Stem Cells in Chinese Adults With Type 2 Diabetes: a Single Center, Double-blind, Randomized, Placebo-controlled Trial

Conditions
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Type 2 Diabetes, Mesenchymal Stem Cells

Intervention / Treatment
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* Biological: Umbilical cord mesenchymal stem cells
* Biological: Controlled suspension liquid


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: UC-MSCs (1.5×106/kg) or the same volume of placebo (suspension liquid without UC-MSCs)
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Umbilical cord mesenchymal stem cells<br>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 | Biological: Umbilical cord mesenchymal stem cells<br>* Infusion treatment<br>|
| Experimental: Controlled suspension liquid<br>Patients receive Controlled suspension liquid | Biological: Controlled suspension liquid<br>* Infusion treatment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The efficacy of umbilical cord mesenchymal stem cells in Chinese adults with T2D | proportion of patients with HbA1c <7.0% and daily insulin reduction ≥50% from baseline to 48 weeks | 48 weeks from baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Other efficacy parameter of umbilical-cord mesenchymal stem cells in Chinese adults with T2D | Changes of insulin requirement, HbA1c and proportion of patients reaching the HbA1c target (<7.0%) | 48 weeks from baseline | 
| Other efficacy parameter of umbilical-cord mesenchymal stem cells in Chinese adults with T2D | Change of islet β cell function and insulin resistance | 48 weeks from baseline | 
| safety parameter of umbilical-cord mesenchymal stem cells in Chinese adults with T2D | Fever, pruritus, nausea and vomiting, anaphylactic shock, phlebitis，tumor formation, infection, impaired liver and kidney function. | 48 weeks from baseline |