Autologous Insulin Producing Mesenchymal Stem Cell Transplantation in Youth With Type 1 Diabetes
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Insulin producing mesenchymal stem cells efficacy in insulin production in vitro
研究概览
简要总结
Type 1 Diabetes is a chronic autoimmune disease. It results from autoimmune destruction of pancreatic Beta cells leading to absolute insulin insufficiency. The establishment of pluripotent like human stem cells derived from adipose tissue derived mesenchymal cell origin have introduced a new potential source for cell therapy in type 1 diabetic patients, especially in light of recent successes in producing glucose-sensitive insulin secreting cells and this will be the scope of this study. In the last decade, human clinical trials of introducing insulin producing stem cells from various origins were approved and conducted.
详细描述
Differentiation of stem cells from various sources to form insulin-producing cells (IPCS) provides a new and promising strategy to reconstitute pancreatic endocrine function. Studies recently developed a multistep differentiation technique for the differentiation of human embryonic stem cells to form pancreatic progenitors. At the end of in vitro differentiation approximately 5% of cells became insulin positive.
Mesenchymal stem cells (MSCs) can be derived from various sources. MSCs are undifferentiated cells with multilinear potential, known for their immunomodulatory and regenerative properties . The bone marrow, adipose tissue, umbilical cord, liver cells, and endometrium are among several tissues that are rich in MSCs. Of these, the bone marrow and adipose tissues offer distinct advantages in view of their availability and abundance and the extent of their documentation.
In this study the investigators aim to obtain autologous differentiated insulin producing mesenchymal stem cells (derived from adipose tissue) and their introduction in human subjects with type 1 diabetes. The current study will assess of the ability of the transplanted cells to produce insulin both in vitro and in vivo. Post- transplant glycemic control will be assessed with possible amelioration of the standard treatment of type 1 diabetes.
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
- None
入排标准
- 年龄范围
- 15 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 1 diabetes
排除标准
- •patients with other autoimmune diseases
- •patients with micro or macro vascular complications
- •patients with other chronic diseases
研究组 & 干预措施
group 1a IPSC transplant in portal circulation
Insulin producing stem cells injection in portal circulation
干预措施: Insulin producing stem cells infusion (Biological)
group 1b IPSC in peripheral systemic circulation
Insulin producing stem cells injection in peripheral systemic circulation
干预措施: Insulin producing stem cells infusion (Biological)
结局指标
主要结局
Insulin producing mesenchymal stem cells efficacy in insulin production in vitro
时间窗: 1 year
Assestment of percentage of mature insulin production and c peptide in insulin producing stem cells in response to different concentrations of glucose.
Insulin producing mesenchymal stem cells efficacy in insulin production in vivo
时间窗: 1 year
Participants glycemic control will be assesed before and after insulin producing stem cells injection.
次要结局
未报告次要终点