NCT05990530招募中2 期
Evaluation of the Efficacy and Safety of Allogeneic Transplantation of Expanded Pancreatic Islet Cells in Patients With "Brittle" Type 1 Diabetes
Shanghai Jiao Tong University School of Medicine1 个研究点 分布在 1 个国家目标入组 6 人开始时间: 2023年2月22日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Residual β-Cell function (RBCF)
研究概览
简要总结
This study will evaluate the efficacy and safety of allogeneic pancreatic islet cells transplantation in patients with "brittle" type 1 diabetes.
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Voluntarily sign an informed consent form and agree to comply with the trial treatment plan and visit schedule.
- •Age ≥18 years and ≤60 years on the day of signing the informed consent form, regardless of gender.
- •Body mass index (BMI) ≥18.0 kg/m2 and ≤35.0 kg/m
- •Diagnosed with T1DM based on the World Health Organization's diabetes classification (2019).
- •HbA1c ≥7.0% and ≤15.0% at screening.
- •Dependence on insulin injection therapy for ≥5 years, receiving a stable insulin treatment plan for ≥3 months, and injecting insulin three or more times per day or using an insulin pump.
- •Postprandial mixed meal stimulated C-peptide level <0.3 ng/mL.
- •Experienced impaired awareness of hypoglycemia or significant glycemic instability during screening and in the past 6 months. Hypoglycemic episodes are associated with impaired awareness of hypoglycemia, extreme glycemic instability, or severe fear and maladaptive behavior.
- •Sexually active males who are not surgically sterilized or have partners of childbearing potential agree to use effective contraception during the entire trial period and for at least 6 months after the study ends; sexually active females of childbearing potential agree to use effective contraception during the entire study period and for at least 6 months after the study ends.
排除标准
- •Types of diabetes other than T1DM.
- •Body mass index (BMI) >35 kg/m2 or weight <50 kg.
- •Excessive insulin sensitivity and/or insulin resistance (insulin requirement >1.0 IU/kg/day or <15 U/day).
- •Previous pancreatic or islet transplantation. Severe trauma, severe infection, or surgery that may affect glycemic control within one month before screening.
- •History of hypertension with systolic blood pressure (SBP) >160 mmHg and/or diastolic blood pressure (DBP) >100 mmHg after stable dose (at least 4 weeks) of antihypertensive medication.
- •Blood transfusion or severe bleeding within the past 3 months, known hemoglobin-related diseases, anemia (moderate to severe), or other known hemoglobinopathies that interfere with HbA1c measurement (such as sickle cell disease).
- •Impaired liver or kidney function at screening: aspartate aminotransferase (AST) ≥3 times the upper limit of normal (ULN), alanine aminotransferase (ALT) ≥3 times ULN, total bilirubin level (TBL) ≥2 times ULN (excluding Gilbert's syndrome), creatinine clearance rate <45 mL/min (calculated by the Cockcroft-Gault formula).
- •Significant albuminuria (urinary albumin excretion rate >300 mg/g) or history thereof.
- •Uncontrolled or untreated thyroid disease or adrenal insufficiency.
- •Severe diabetic kidney disease or renal insufficiency, proliferative retinopathy, diabetic foot ulcers, diabetes-related amputation, and/or severe peripheral neuropathy at screening.
- •Active hepatitis B, hepatitis C, acquired immunodeficiency syndrome, syphilis, or tuberculosis. Even without clinical evidence of active infection, participants with laboratory evidence of active infection are also excluded.
- •Severe heart disease or a history of cardiovascular disease within 6 months before screening, including stroke, decompensated heart failure (NYHA class III or IV), myocardial infarction, unstable angina, or coronary artery bypass grafting.
- •Previous history of coagulation disorders or requiring long-term anticoagulant therapy (e.g., warfarin) (low-dose aspirin therapy is allowed) or patients with INR >1.
- •Substance abusers with a history of drug abuse/dependence or drug use within 1 year before screening.
- •Received live vaccines within 14 days before screening or planned to receive live vaccines during the trial or within 1 month after treatment. Live vaccines include, but are not limited to, measles, mumps, rubella, varicella, yellow fever, rabies, Bacillus Calmette-Guérin, typhoid vaccine, COVID-19 vaccine, etc.
- •Patients with a history of acute or chronic pancreatitis, symptomatic gallbladder disease, pancreatic injury, or other high-risk factors for pancreatitis, or patients with blood amylase >1.2 times ULN at screening.
- •Other abnormal laboratory test results deemed clinically significant by the investigator.
- •Patients with severe mental illness.
- •Participated in a drug or medical device clinical trial within the past 3 months and received investigational drugs or medical devices; or within 5 half-lives of another drug before screening (if the half-life exceeds 3 months).
- •Currently receiving long-term (continuous for ≥14 days) systemic pharmacological doses of glucocorticoids or other medications that may affect the participant's consciousness.
- •Treatment (local, intra-articular, intraocular, or inhalation preparations) for any other factors or diseases not mentioned above, deemed unsuitable for participation in this clinical study by the investigator.
结局指标
主要结局
Residual β-Cell function (RBCF)
时间窗: 12 months post-transplant
Evaluation of the magnitude of C-peptide change after transplantation
次要结局
- Glycemic control (HbA1c)(52 weeks post-transplant)
- Treatment (insulin-independent)(12 weeks and 52 weeks post-transplant)
- Treatment (insulin requirement)(12 weeks and 52 weeks post-transplant)
- Glycemic control (MAGE)(12 weeks and 52 weeks post-transplant)
- Hypoglycemia (HYPO)(baseline and 52 weeks post-transplant)
- Quality of life score(baseline and 52 weeks post-transplant)
研究者
研究点 (1)
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