Effectivity and Safety of Autologous BM-MNC Stem Cell Therapy and Allogenic Umbilical Cord Mesenchymal Stem Cell for Type 2 Diabetes Mellitus Patients"
试验速览
- 阶段
- 1 期
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Decreasing total daily dose of insulin (>= 30%)
研究概览
简要总结
The aim of this preliminary study is to evaluate the safety and efficacy of bone-marrow mononuclear cells (BM-MNCs) and umbilical-cord tissue-derived mesenchymal stem cells (UC-MSCs) administration in type 2 diabetes patients
详细描述
Type 2 diabetes (T2D) patients had peripheral insulin resistance accompanied by progressive pancreatic beta cell degeneration and dysfunction due to glucotoxicity and lipotoxicity. Several studies have shown that the immune system plays a significant role in the pathogenesis of T2D. Bone-marrow mononuclear cells (BM-MNCs) and umbilical-cord tissue-derived mesenchymal stem cells (UC-MSCs) via its immunomodulatory properties have the potential to improve insulin resistance condition and pancreatic beta-cells dysfunction thus improve the glycemic control and insulin requirement in T2D patients. In this pilot study, we plan to recruit 15 T2D patients with total daily dose of insulin >= 0.5 unit/kgBW/day to receive BM-MNCs (5 subjects) or UC-MSCs injections (10 subjects). These subjects will be closely followed up for 12 months for evaluation of primary and secondary outcome.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 2 diabetes patients on insulin therapy with or without oral hypoglycemic agents, with total daily dose of insulin >= 0,5 unit/kg body weight
- •Stable HbA1C in the last six months (HbA1c <= 8.5%)
排除标准
- •Type 1 diabetes mellitus
- •eGFR < 45 mL/min/m2 (for BM-MNC)
- •Liver disease (moderate- severe)
- •Active infection
- •Contrast hypersensitivity (for BM-MNC)
- •History of Malignancy
- •Acute coronary syndrome in last three months
- •Coronary arterial diseases with significant stenosis and has not carried out revascularization
- •Pregnancy (for women subjects)
结局指标
主要结局
Decreasing total daily dose of insulin (>= 30%)
时间窗: Before intervention, 1st, 3rd, 6th, and 12th month after intervention
After intervention, blood glucose level will be reported by the subjects on weekly basis. The insulin dose and/or oral medication will be adjusted accordingly.
次要结局
- Increasing of C-peptide level(Before intervention, 1st, 3rd, 6th, and 12th month after intervention)
- Immunology/inflammatory markers(Before intervention, 1st, 3rd, 6th, and 12th month after intervention)
- HbA1c(Before intervention, 1st, 3rd, 6th, and 12th month after intervention)
- Decreasing of insulin resistance level(Before intervention, 1st, 3rd, 6th, and 12th month after intervention)
- Adverse events(Up to 12 months after intervention)
研究者
Prof. Dr. dr. Pradana Soewondo, SpPD-KEMD
Prof
Fakultas Kedokteran Universitas Indonesia