Phase I Open Label Clinical Trial to Evaluate Safety of Adipose Derived Mesenchymal Stem Cell Transplantation for Type 1 Diabetes Treatment
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Safety measure
研究概览
简要总结
The purpose of this study is to evaluate the safety of intravenously (IV) administered adipose-derived mesenchymal stem cell (AD-MSC) in patients with type 1 diabetes mellitus (T1D)
详细描述
Adipose derived mesenchymal stem cells (AD-MSCs) has many advantages, i.e. the greater ease of access and harvesting by means such as subcutaneous lipoaspiration, a much less painful procedure than harvesting bone marrow stem cells, and a much less ethical concern because they are harvested from autologous fat. The purpose of this study is to evaluate the safety of intravenously (IV) administered adipose-derived mesenchymal stem cell (AD-MSC) in treatment 10 patients with type 1 diabetes mellitus (T1D) at Vinmec International Hospital, Hanoi, Vietnam.
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
- 5 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient diagnosed T1D (according to the instructions of the Ministry of Health No: 5481/QD-BYT dated December 30, 2020)
- •Aged from 5 years and over.
- •The time from the diagnosis of type 1 diabetes to enrollment ≤ 12 months.
- •Blood testing conducted at the time of diagnosis:
- •Fasting blood glucose ≥ 7 mmol / L,
- •HbA1C ≥ 6.5%.
- •Have at least one antibodies associated with T1D such as ICA; GAD; ZnT8 or IAA.
- •At the time of screening at Vinmec for study enrollment, patients are actively managing their blood glucose levels with insulin.
- •The patient does not have other serious acute illness requiring treatment
- •The patient agrees to use stem cell transplant for treatment
- •The patient's parent (parent or legal guardian) can read, write, understand the ICF form and agree to sign a consent to participate in the study.
排除标准
- •Having evidence related to renal dysfunction: creatinine > 1.5 mg/dl or (>133 mmol/L) for boys, creatinine > 1.4 mg/dl or (>124 mmol/L) for girls
- •In case of kidney failure. Proteinuria within the range of nephrotic syndrome (>3.5 g/day or ratio of protein/creatinine in urine >2.7)
- •In case of kidney failure
- •Having severe infection or infected with hepatitis B virus, hepatitis C virus, HIV virus, or tuberculosis
- •Cardiovascular disease, respiratory disease (pulmonary, fibrosis, chronic respiratory failure), liver disease, cancer or neurological disease
- •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
- •History of allergic reaction to anesthetic agents and/or antibiotics
结局指标
主要结局
Safety measure
时间窗: up to the 6-month period following treatment
Safety is recognized as number of adverse events (AE) and serious adverse events (SAE) appear from the time that patients sign in ICF
次要结局
- Fasting blood glucose (FPG)(up to the 6-month period following treatment)
- C-peptide levels(up to the 6-month period following treatment)
- Blood insulin(up to the 6-month period following treatment)
- HbA1c(up to the 6-month period following treatment)
- Insulin dose(up to the 6-month period following treatment)