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临床试验/NCT00465478
NCT00465478Unknown1 期

Autologous Bone Marrow Mononuclear Cell Transplantation in Treating Patients With Type 1 or 2 Diabetes Mellitus-a Phase 1/2 Study

Shandong University1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2006年3月1日最近更新:
适应症

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

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

研究者

发起方
Shandong University
申办方类型
Other

研究点 (1)

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