Phase 1/2 Clinical Study of MenSCs Infusion in Type 1 Diabetes
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Glycosylated hemoglobin (HbA1c)
研究概览
简要总结
The purpose of this study is to investigate whether the treatment of human menstrual blood-derived mesenchymal stem cells which would be applied to diabetes patients is safe and effective.
详细描述
Diabetes mellitus is chronic metabolic diease caused by absent or rejection insulin from pancreatic b cells.The traditional treatment strategies for diabetes are daily injections with insulin and transplantation of islets from cadaver. However, daily injuection is very inconvenient and there is a shortage of organs and life long immunosuppression. Therefore, such therapy can be offered to a very limited number of patients only. MSC-based therapeutic intervention has become an emerging strategy for the replacement of injured tissues. MSCs also have been noted to possess immunomodulatory effects in vivo. Thus, their potential for clinical use as a cell-based therapy should be focused and observation.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •male and female patients at the age of 18 to
- •agreement to receive written informed consent.
- •voluntary submission to the procedures of the study protocol.
- •clinical diagnosis is classified to type 1 diabetes(T1DM).
- •T1DM duration ≥ 1 and ≤ 20 years from the time of enrollment.
排除标准
- •renal dysfunction, eye disease or other organ disease.
- •cardiovascular disease, existing congestive cardiac failure on physical exam and/or acute coronary syndrome in past 6 months.
- •pregnancy
- •mental disorders
- •hepatitis C, HIV, RPR,active tuberculosis or blood diseases
- •any malignancy
- •any other severe diseases that could potentially influence the infusion results
研究组 & 干预措施
Traditional therapy control
干预措施: exogenous indulin injection daily (Drug)
Stem cell infusion
干预措施: MenSCs transplantation (Biological)
结局指标
主要结局
Glycosylated hemoglobin (HbA1c)
时间窗: 1 year
次要结局
- The postprandial blood glucose(1 year)
- The random glucose level(2 years)
- The acute reaction and severity of adverse events related to the stem cell infusion procedure(2 years)
- Number of severe and documented hypoglycemic events(2 years)
- C-peptide release test(3 months)
- The reduction in fasting blood glucose (FBG)(1 year)
- The increase in basal C-peptide(1 year)