Efficacy Of Autologous Bone Marrow Derived Stem Cell Transplantation In Patients With Type 2 Diabetes Mellitus
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Reduction of insulin requirement by ≥ 50% by the end of 6 months of ABMSCT and Improvement in Glucagon stimulated C - peptide levels .
研究概览
简要总结
The purpose of this study is to improve blood glucose control in Type 2 Diabetes mellitus patients.
详细描述
We hypothesize that Autologous bone marrow derived stem cell transplantation(ABMSCT)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 ABMSCT 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 microenvironment which supports beta cell/resident stem cell activation and survival.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 30 Years 至 75 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 OHA and on stable doses of insulin for atleast 3 months.
- •On vildagliptin,pioglitazone and metformin for atleast 3 months along with Insulin to maintain euglycemia.
- •HbA1c < 8.5%.
- •Insulin requirement ≥0.4 IU/kg/d.
- •GAD antibody negative status.
排除标准
- •Patients with T1DM 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/ cholelitiasis/ cholecystectomy
- •Seropositivity for HIV, HBsAg and 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 ABMSCT and Improvement in Glucagon stimulated C - peptide levels .
时间窗: 6 months
次要结局
- Any reduction in requirement of insulin dosage and any improvement of HbA1c levels as compared to controls.(6 months)
研究者
Anil Bhansali
head of department
Post Graduate Institute of Medical Education and Research, Chandigarh