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
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 103
- 试验地点
- 1
- 主要终点
- The efficacy of umbilical cord mesenchymal stem cells in Chinese adults with T2D
研究概览
简要总结
Umbilical cord mesenchymal stem cells indicate the therapeutic effects and safety on type 2 diabetes by characteristics of secretion and immune Immunomodulation.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
The efficacy of umbilical cord mesenchymal stem cells in Chinese adults with T2D
时间窗: 48 weeks from baseline
proportion of patients with HbA1c \<7.0% and daily insulin reduction ≥50% from baseline to 48 weeks
次要结局
- safety parameter of umbilical-cord mesenchymal stem cells in Chinese adults with T2D(48 weeks from baseline)
- Other efficacy parameter of umbilical-cord mesenchymal stem cells in Chinese adults with T2D(48 weeks from baseline)
研究者
Yiming Mu
Director
Chinese PLA General Hospital