NCT03728296Unknown早期 1 期
Clinical Study on the Safety and Efficacy of Autologous Induced Islet Body With Type 1 Diabetes
Allife Medical Science and Technology Co., Ltd.0 个研究点目标入组 20 人开始时间: 2019年1月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 早期 1 期
- 发起方
- 入组人数
- 20
- 主要终点
- Occurrence of treatment related adverse events as assessed by CTCAE v4.0
研究概览
简要总结
This is a single centre、single arm、open-label study，to investigate the safety and efficacy of Autologous induced islet body With Type 1 diabetes
研究设计
- 研究类型
- Interventional
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, 18 to 70 years old (including 18 and 70 years old)
- •Diagnosed as type I diabetes, the diagnostic criteria refer to the 1990 WHO diabetes diagnostic criteria:
- •（1）Diabetes symptoms (hyperglycemia caused by polydipsia, polyphagia, weight loss, itchy skin, blurred vision and other acute metabolic disorders) + random blood glucose ≥ 11.1nmol / L; （2）Fasting blood glucose ≥7.0mmol/L or 75g glucose meets 2-hour blood glucose ≥11.1mmol/L.
- •3、Voluntary informed consent is given, agree to follow the trial treatment and visit plan.
- •Note: 2 is the venous plasma glucose level, if there is no diabetes symptoms, it is necessary to repeat the test on the next day.
排除标准
- •Patients with acute complications of diabetes: including diabetic ketosis, diabetic ketoacidosis, diabetes, hyperglycemia, hypertonic state, etc.
- •Patients with Severe bacterial and viral infections
- •patients are participating in other clinical trials and treating with other immune cellular products (DC, CIK, T, NK, and Car T products with CD19 or other targets)
- •Patients with severe cardiovascular and cerebrovascular disease (NYHA class 3-4) cannot cooperate with the study
- •Patients with severe liver dysfunction(liver function AST and ALT exceeded 2.5 times the normal upper limit).
- •Patients with kidney disease or moderate to severe renal insufficiency (renal function eGFR <60 ml/min/1.73 m2)
- •Women in pregnancy (urine/blood pregnancy test positive) or lactation; men or women with pregnancy plans in the last year; patients are not guaranteed to take effective contraceptive measures during the trial;
- •patients were diagnosed as tumor or tumor chemotherapy, radiotherapy and acute uric acid nephropathy within 5 years.
- •Other circumstances that researchers do not consider suitable for research.
- •Withdrawal from trial, loss of follow-up or death due to other reasons
- •Incomplete data, affecting effectiveness and safety judges
- •Researchers believe that the need for termination of the trial is needed.
研究组 & 干预措施
islet body treatment group
Experimental
干预措施: islet body (Biological)
结局指标
主要结局
Occurrence of treatment related adverse events as assessed by CTCAE v4.0
时间窗: 1 year
Defined as \>= Grade 3 signs/symptoms, laboratory toxicities, and clinical events) that are possibly, likely, or definitely related to study treatment
次要结局
未报告次要终点
研究者
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