Autologous Bone Marrow Mononuclear Cell Transplantation in Treating Patients With Type 1 or 2 Diabetes Mellitus-a Phase 1/2 Study
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Exogenous insulin requirement; Hemoglobin A1C; Glucose and C-peptide level;
研究概览
简要总结
The study evaluates the safety and efficiency of autologous bone marrow mononuclear cell transplantation in treating patients with type 1 or 2 Diabetes Mellitus. We hypothesize that autologous bone marrow stem cell transplantation will promote β-cells regeneration by directly differentiated from the transplanted BMMCs or stimulated local stem cells regeneration and thus decrease or eliminate the need of exogenous insulin and improve β-cells function.
详细描述
Patients with type 1 or 2 Diabetes mellitus will be recruited according to eligibility criteria. Bone marrow mononuclear cells (BMMCs) will be separated from the bone marrow aspirate of each patient and be directly delivered to pancreas via splenic artery with the distal lumen occlusion through an arterial catheter. All patients will be explained in details about the procedures involved in BMMC transplantation and sign the informed consent for the study; The Ethics Committee of Qilu hospital, ShanDong university approved the treatment protocol. All patients undergo scheduled follow-up evaluations for 5 years after transplantation. Clinical, hematological, metabolical evaluations are performed to analyses the effect of the transplant, Patients fitting the inclusion criteria but not agreeing to perform the transplantation are the control group and will received the regular OHA and/or insulin therapy .They are followed in parallel with transplanted patients and will be subjected to the same follow-up management including extensive endocrinological monitoring, diet and exercise program as transplantation patients during the follow-up.
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
- 16 Years 至 65 Years(Child, Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 1 or type 2 diabetes
- •Between 16 to 65 years of age
- •Requiring daily exogenous insulin injection for the glycaemic control
- •With poor β-cell function
- •Body mass index (BMI) < 28
排除标准
- •Acute or chronic infections
- •Chronic uncompensated organic insufficiency including heart, liver, renal and lung
- •Any malignancies, congenital or acquired immunodeficiency
- •Hematological diseases or coagulopathy
- •Acute or chronic pancreatitis
- •History of thoracic or abdominal aorta diseases
- •Allergy to iodine
- •Pregnancy
结局指标
主要结局
Exogenous insulin requirement; Hemoglobin A1C; Glucose and C-peptide level;
次要结局
- Safety assessment parameter: amylase, hepatic function,renal function,
- lipid profile, autoantibody, Quality of life
