A Preliminary Safety and Efficacy Evaluation of Mesenchymal Stem Cell Transplantation for Type 1 Diabetes Mellitus (T1DM) Patients
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Hemoglobin A1c (HbA1c) level
研究概览
简要总结
The purpose of this study is to evaluate the safety and efficacy of mesenchymal stem cells (MSCs) transplantation for type 1 Diabetes Mellitus patients.
详细描述
Mesenchymal stem cells (MSCs) are collected from autologous bone marrow mononuclear cells and allogeneic umbilical cord tissue (UC-MSC).
15 patients with type 1 Diabetes Mellitus will be enrolled and will receive MSCs by intravenous infusion. They were followed up for 6 months after transplantation.
Safety is to assess the occurrence of adverse events (AEs) during either stem cells infusion or by physician assessments.
The primary endpoint is to assess the improvement of patients' Fasting blood glucose, HbA1C, C-peptide, and blood insulin level.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Who is diagnosed with Type 1 Diabetes Mellitus according to the ADA, the patients meet at least one of the following criteria:
- •At least one autoantibody associated with Type 1 Diabetes Mellitus such as ICA or GAD.
- •Previously diagnosed at a medical facility with Type 1 Diabetes.
- •Having evidence of insulin depletion based on the test results during screening.
- •Patients treated with fixed insulin dose for at least 3 months.
- •Males and females between age 18 and 45 years at the screening.
- •Patients able to read, write and understand ICF form
排除标准
- •Uncontrolled blood pressure at the time of enrollment: systolic pressure >160 mmHg and/or diastolic blood pressure > 100 mmHg.
- •Having evidence related to renal dysfunction:
- •creatinine > 1.5 mg/dl or (>133 mmol/L) for men.
- •creatinine > 1.4 mg/dl or (>124 mmol/L) for woman.
- •eGRF < 40 ml/ min
- •Proteinuria > 300 mg/day
- •Having evidence of ketoacidosis at the time of selection.
- •Having evidence of ongoing or frequent hypoglycemia.
- •Having severe infection
- •Infected with hepatitis B virus or hepatitis C or tuberculosis. Positive results of HbsAg or Anti HCV or/and PCR tuberculosis are only acceptable in case of vaccination and without suspicious signs. All other cases are not accepted even in the absence of clinical signs.
- •Diseases detected before/during screening such as cardiovascular disease, respiratory disease ( pulmonary, fibrosis, chronic respiratory failure), liver disease, cancer, neurology, metabolism.
- •Having abnormalities in red blood cells such as sickle cells disease.
- •Using alcohol and/or tobacco.
- •Blood clotting disorders (INR > 1.5, PTT >40, PT > 15).
- •Taking any anticoagulant.
- •Taking systemic steroids.
- •Participate in another clinical study involving experimenting drugs and/or medical equipment.
- •Patients who are unable to perform the tests and assessments needed for the study (eg, patients who are unable to perform bone marrow transplantation) or patients who do not agree to participate in the study.
结局指标
主要结局
Hemoglobin A1c (HbA1c) level
时间窗: 1 month, 3 months and 6 months after transplantation
Assess the changes in HbA1C level after transplantation
Adverse events
时间窗: during the course of 6 months
Evaluate the safety of therapy by number record of adverse events (AEs)
Fasting blood glucose
时间窗: every month in the course of 6 months
Assess the changes in fasting blood glucose level after transplantation
次要结局
- Insulin dose(during the course of 6 months)
- C-peptide(every month in the course of 6 months)
- Blood insulin level(every month in the course of 6 months)