NCT07503028Enrolling By Invitation1 期
An Exploratory Clinical Study Evaluating Allogeneic iPSC-derived Pancreatic Islet Cells (CRG-002) for the Treatment of Diabetic Patients With Hypoglycemia Unawareness or Severe Hypoglycemic Events
Celregen Therapeutics0 个研究点目标入组 10 人开始时间: 2025年10月17日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 10
- 主要终点
- Safety as assessed by number of adverse events accoridng to CTCAE v 6.0
研究概览
简要总结
This study is an open-label, single-arm, non-randomized trial designed to evaluate the safety and preliminary efficacy of CRG-002 administered via portal vein infusion or transplantation beneath the anterior rectus sheath in patients with type 1 diabetes mellitus (T1DM) or pancreatogenic diabetes who have hypoglycemia unawareness or severe hypoglycemic events.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-70 years, any gender.
- •Long-standing type 1 diabetes or pancreatic diabetes.
- •Significant pancreatic islet dysfunction.
- •Hemoglobin A1c within clinically acceptable range.
- •At least 1 hypoglycemic event requiring external intervention within 12 months.
- •Able to comply with intensive glucose management.
- •Agree to use the study-designated monitoring device.
- •Psychologically stable.
- •Full legal capacity.
排除标准
- •Type 2 diabetes.
- •Body mass index (BMI) > 30 kg/m².
- •Uncontrolled diabetic retinopathy or severe diabetic foot complications.
- •Active infection or positive serology for relevant pathogens.
- •Severe cardiovascular disease.
- •Uncontrolled hypertension.
- •Hematologic disorders affecting HbA1c accuracy.
- •Abnormal liver function.
- •Prior islet transplantation.
- •Renal impairment or insufficient post-transplant recovery.
- •Significant renal impairment.
- •Recent invasive fungal infection.
- •Severe hematologic abnormalities.
- •Coagulopathy.
- •Inadequate contraceptive compliance.
- •Active malignancy.
- •History of substance abuse.
- •Severe gastrointestinal/malabsorption disorders.
- •Severe psychiatric disorder.
- •Participation in other clinical trials within 6 months.
- •Live-attenuated vaccine received within 2 months prior to enrollment.
- •Inability to undergo standard imaging.
- •Other factors deemed unsuitable by investigator.
结局指标
主要结局
Safety as assessed by number of adverse events accoridng to CTCAE v 6.0
时间窗: Within one year after CRG-002 transplantation
Number of adverse events as assessed by CTCAE v6.0，including Adverse Events of Special Interest (AESI), Treatment-Related Adverse Events (TEAE), Treatment-Related Adverse Events (TRAE), and Procedure-Related Adverse Events (PRAE); Serious Adverse Events (SAE), Treatment-Related Serious Adverse Events (TRSAE), and Procedure-Related Serious Adverse Events (PRAE)
次要结局
- Time to subjects achieving insulin independence.(Within one year after CRG-002 transplantation)
- Numbers of subjects achieving insulin independence.(Within one year after CRG-002 transplantation)
- Daily insulin dosage of subjects(Within one year after CRG-002 transplantation)
- Changes in blood glucose levels(Within one year after CRG-002 transplantation)
- Changes in Time in range of glucose(Within one year after CRG-002 transplantation)
- Time to achieving HbA1c <7.0% (if baseline HbA1c ≥7.0%) or a ≥1% reduction from baseline.(Within one year after CRG-002 transplantation)
- Number of subjects achieving HbA1c <7.0% (if baseline HbA1c ≥7.0%) or ≥1% HbA1c reduction from baseline (if baseline HbA1c <7.0%).(Within one year after CRG-002 transplantation)
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