Efficacy and Safety of Autologous Bone Marrow Derived Stem Cell Transplantation in Patients With Type 2 Diabetes Mellitus
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Reduction of insulin requirement by ≥ 50% by the end of 6 months of autologous bone marrow derived stem cell transplantation and Improvement in Glucagon stimulated C - peptide levels and hyperglycemic clamp for assessment of beta cell function
研究概览
简要总结
The purpose of this study is to improve the blood glucose level in type 2 diabetic patients.
详细描述
We hypothesize that Autologous bone marrow derived stem cells which would be expanded into culture and their subsequent transplant into the pancreas of patients with T2DM, aged 30 - 70 years with triple oral hypoglycemic agent failure and on insulin(>0.4 U/ kg body weight/day) will lead to abolition or reduction of insulin requirement by more than or equal to 50% in these patients over a period of 6 months. It is assumed that stem cell in these patients leads to increased angiogenesis, secretion of various cytokines and upregulation of pancreatic transcription factors and Vascular endothelial growth factor(VEGF) and creates a micro-environment which supports beta cell/resident stem cell activation and survival.
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
- Single (Participant)
入排标准
- 年龄范围
- 30 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with type 2 diabetes mellitus between 30 and 70 years of age.
- •Failure to triple oral hypoglycemic agent and on stable doses of insulin for at least 3 months.
- •On vildagliptin,pioglitazone and metformin for at least 3 months along with Insulin to maintain euglycemia.
- •HbA1c < 7.5%.
- •Insulin requirement ≥0.4 IU/kg/d.
- •GAD antibody negative status.
排除标准
- •Patients with type 1 diabetes mellitus or secondary diabetes.
- •Patients with serum creatinine > 1.5 mg/dl.
- •Abnormal liver function tests (defined as value of transaminases > 3 times the upper value of normal or serum bilirubin higher than normal for the reference value for the laboratory).
- •History of cholecystitis/ cholelithiasis/ cholecystectomy
- •Seropositivity for HIV, HBsAg and hepatitis C virus (HCV).
- •History of myocardial infarction or unstable angina in the previous 3 months.
- •History of malignancy
- •Patients with active infections.
结局指标
主要结局
Reduction of insulin requirement by ≥ 50% by the end of 6 months of autologous bone marrow derived stem cell transplantation and Improvement in Glucagon stimulated C - peptide levels and hyperglycemic clamp for assessment of beta cell function
时间窗: 6 months
次要结局
未报告次要终点
研究者
Anil Bhansali
Professor and HOD
Post Graduate Institute of Medical Education and Research, Chandigarh