A Preliminary Safety and Efficacy Evaluation of Bone Marrow Mononuclear Cells (BM-MNCs) and Umbilical Cord Tissue-derived Mesenchymal Stem Cells (UC-MSC) Infusion for Type 2 Diabetes Mellitus (T2DM) Patients
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- The level of C-peptid and HOMA-β
研究概览
简要总结
The purpose of this study is to evaluate the preliminary safety and efficacy of autologous bone marrow mononuclear cells (BM-MNCs) and allogeneic umbilical cord tissue-derived mesenchymal stem cells (UC-MSCs) infusion in type 2 Diabetes Mellitus patients.
详细描述
Mononuclear cells are collected from autologous bone marrow and allogeneic mesenchymal stem cells are isolated and cultured from umbilical cord tissues.
30 patients with Type 2 Diabetes Mellitus will be enrolled and received mononuclear cell and mesenchymal stem cell by intravenous infusion and followed up for 6 months. The other 30 patients with Type 2 Diabetes Mellitus will be enrolled and treated by standard medicines, which would be used as the control group.
Safety is to assess the occurrence of adverse events (AEs) during either stem cells infusion or by physician assessments.
The primary endpoint is to assess the improvement of patient's C-peptid and HOMA-β, HOMA-IR, cytokines TNF-α, IL-1β, Blood glucose level, Hemoglobin A1c (HbA1c) level.
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
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Who is diagnosed with Type 2 Diabetes Mellitus according to the ADA 3 years or more
- •Patients are able to read, write and understand ICF form and agree to participate in the study
- •Males and females between age 18 and 70 years at the screening.
- •FBG > 7 mmol/L
- •8% ≤ HbA1C ≤ 11%
- •Fasting C-peptide > 0.6 ng/ml
- •Anti GAD (-)
- •The patient is treated by two oral diabetes medications but uncontrolled blood glucose (HbA1C ≥ 8%)
排除标准
- •Pregnant women, planning to become pregnant and lactating women during the study period
- •The patient has a disease or a history of vascular disease; history of abdominal or chest aortic disease;
- •Patients are diagnosed with heart failure degree IV according to NYHA or kidney failure degree IV according to KDIGO;
- •Patients with severe malignancy or dysplasia within 5 years prior to the study period or who are suffering from severe malignant or dysplasia
- •Infection is undergoing antibiotic treatment or antibiotics have just been discontinued within 14 days
- •Hematologic disease or coagulopathy
- •There are abnormalities in liver function (AST and/or ALT ≥ 2 times or bilirubin ≥ 2.0 times normal value at the time of screening);
- •Patients with immunodeficiency diseases such as HIV or hepatitis B and C;
- •Acute or chronic pancreatitis or a history of acute pancreatitis;
- •Patients taking immunosuppressive drugs (such as azathioprine, methotrexate) within 6 months before the study time or taking immunosuppressive drugs;
- •The patient is unable to complete the study;
- •The patient is participating in another study.
研究组 & 干预措施
BM-MNC and UC-MSC
30 patients with Type 2 Diabetes Mellitus will be enrolled and received mononuclear cells and mesenchymal stem cells by intravenous infusion.
干预措施: BM-MNC and UC-MSC (Biological)
Stand medicines
30 patients with Type 2 Diabetes Mellitus will be enrolled and treated by standard medicines.
干预措施: Control (Other)
结局指标
主要结局
The level of C-peptid and HOMA-β
时间窗: enrollment, 1 month, 3 months and 6 months after transplantation
Assess the changes in C-peptid and HOMA-β level after transplantation
Hemoglobin A1c (HbA1c) level
时间窗: enrollment, 1 month, 3 months and 6 months after transplantation
Assess the changes in HbA1C level after transplantation
Adverse events
时间窗: during the course of 6 months
Number of adverse events in both groups
The level of HOMA-IR and cytokines TNF-α, IL-1β
时间窗: enrollment, 1 month, 3 months and 6 months after transplantation
Assess the changes in HOMA-IR and cytokines TNF-α, IL-1β level after transplantation
Blood glucose level
时间窗: enrollment, 1 month, 3 months and 6 months after transplantation
Assess the changes in Blood glucose level after transplantation
次要结局
- Insulin dose and drug dosage(enrollment, 1 month, 3 months and 6 months after transplantation)