NCT07126873招募中1 期
A Phase 1/2a Study to Evaluate the Safety, Tolerability, and Efficacy of E-islet 01 in Subjects Who Have Type 1 Diabetes Mellitus With Impaired Hypoglycemic Awareness and Severe Hypoglycemia
EndoCell Therapeutics, Inc.1 个研究点 分布在 1 个国家目标入组 21 人开始时间: 2025年8月11日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Proportion of Participants Free of Severe Hypoglycemic Events With Either a Glycated Haemoglobin (HbA1c) <7.0% or a ≥ 1% Reduction in Glycosylated hemoglobin(HbA1c) From Baseline
研究概览
简要总结
This study will evaluate the safety, tolerability and efficacy of E-islet 01 in participants with Type 1 diabetes mellitus (T1D) and impaired awareness of hypoglycemia (IAH) and severe hypoglycemia
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical history of Type 1 Diabetes with > 5 years of duration
- •2-hour C-peptide level <0.3 ng/mL after a mixed meal stimulation test
- •Under continuous insulin therapy, Participants have at least one of the following conditions:
- •At least one episode of documented severe hypoglycemia in the 12 months prior to enrollment;
- •Unaware hypoglycemia evaluated using the Clarke scoring system
- •Willing and able to conduct self-blood glucose monitoring as required, with good compliance
- •Voluntarily participate and sign the informed consent form
排除标准
- •Uncontrolled systemic infections, including but not limited to pulmonary tuberculosis, active hepatitis, a history of positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV-Ab), human immunodeficiency virus antibody (HIV-Ab), or Treponema pallidum antibody (TP-Ab).
- •History of malignancy within the past 5 years or undergoing antitumor treatment
- •Participation in other clinical trials in the 3 months or islet cell transplant, organ transplant, or cell therapy in the 12 months prior to enrollment
- •Other situations judged by the investigator as unsuitable for participation in the trial
研究组 & 干预措施
Allogeneic Human E-islet (E-islet 01)
Experimental
干预措施: Allogeneic Human E-islet (E-islet 01) (Biological)
结局指标
主要结局
Proportion of Participants Free of Severe Hypoglycemic Events With Either a Glycated Haemoglobin (HbA1c) <7.0% or a ≥ 1% Reduction in Glycosylated hemoglobin(HbA1c) From Baseline
时间窗: At 1 year after E-islet 01 infusion
Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
时间窗: From E-islet 01 infusion to end of study (up to 5 years)
次要结局
- Proportion of Participants who are Time in range (TIR) >70%(At 1 year after E-islet 01 infusion)
- Number of participants with increase in fasting C-peptide and stimulated C-peptide from baseline(At 1 year after E-islet 01 infusion)
- Proportion of Participants who are Insulin Independent or Reduction in Exogenous Insulin(At 1 year after E-islet 01 infusion)
研究者
研究点 (1)
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