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临床试验/NCT03562208
NCT03562208Unknown2 期

Autologous Bone Marrow Transplant in Chronic Insulin Dependent Diabetic Patients Phase II Clinical Trial. Version: 1.3 - January 13, 2016

Global Cell Med1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2018年1月1日最近更新:
适应症

试验速览

阶段
2 期
入组人数
100
试验地点
1
主要终点
C Peptide

研究概览

简要总结

Diabetes, recently declared a pandemic by the World Health Organization, is a risk factor for increased mortality and morbidity. Its multi-functional complications, in the short and long term, are a serious problems for the global public health. Millions of patients, the world over, suffer Diabetes, a chronic and degenerative disease without treatments today. America, and particularly the Caribbean and Central America Region, is seriously affected despite the efforts of the Public Health Systems. Caribbean Region presented nearly twice the incidence and prevalence of type 1 and type 2 diabetes when compared with the rest of the Americas. Today stem cells are emerging as a valid alternative of treatment. In vitro experiments with adult stem cells demonstrated their ability to migrate and differentiate into cells of different lineages. The bone marrow stem cells are safe, effective and have a lot of scientific evidence that supports the carrying out of clinical research in phases II and III. Our protocol is an Autologous Bone Marrow Stem Cell Transplantation, without immune suppression or cell cultures. Our hypothesis is that the stem cells will act as immune modulators, angiogenic and in a regenerative way stimulating quiescent stem cells and improving the metabolic control by endogenous secretion of insulin.

详细描述

Our clinical trial, authorized and controlled by the Government of Bahamas, offer safety data and effectiveness that encourage continued research. We will divide the patients into a treatment group and into a control group. We will control insulin daly dose, c peptide, A1C glycated hemoglobin and specific antibodies. Follow up two years.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
None

入排标准

年龄范围
16 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients diagnosed with chronic insulin dependent type 1 or 2 diabetes, with negative specific antibodies (Islets, GAD, E2) and low basal c peptide (Using C-peptide measurement (NV 0.9 mg / dl). Men and women, between 16 and 70 years old, derived voluntarily by their family doctors.

排除标准

  • 未提供

结局指标

主要结局

C Peptide

时间窗: two years

C Peptide measurement

次要结局

  • A1C(Two Years)
  • Insulin Daly Dose(Two years)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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