NCT05990517招募中2 期
Evaluation of the Efficacy and Safety of Autologous Transplantation of Expanded Pancreatic Islet Cells (YD01-2022) in Patients With Diabetes Mellitus After Total Pancreatectomy
Shanghai Jiao Tong University School of Medicine1 个研究点 分布在 1 个国家目标入组 3 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
- 3
- 试验地点
- 1
- 主要终点
- C-peptide change
研究概览
简要总结
This study will evaluate the efficacy and safety of autologous transplantation of expanded pancreatic islet cells in patients with diabetes mellitus after total pancreatectomy.
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 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.
- •Diagnosed with chronic pancreatitis and indication for total pancreatectomy.
- •Post-total pancreatectomy, experiencing elevated blood glucose levels and meeting the diagnostic criteria for diabetes (World Health Organization, 2019 edition).
- •Post-mixed meal stimulation, C-peptide level <0.3 ng/mL at 120 minutes.
- •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.
- •History of diabetes or preoperative diagnosis of hyperglycemia, meeting the diagnostic criteria for diabetes.
- •Previous pancreatic or islet transplantation.
- •Uncontrolled hypertension, such as systolic blood pressure (SBP) >160 mmHg and/or diastolic blood pressure (DBP) >100 mmHg despite stable dose (at least 4 weeks) of antihypertensive medication.
- •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 (reference range from the study center's laboratory): 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 thyroid disease or adrenal insufficiency.
- •Positive hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) with peripheral blood hepatitis B virus (HBV) DNA ≥104 copies or ≥2000 IU/mL (HBsAg positive with HBV DNA <2000 IU/mL (<104/mL) must receive antiviral treatment throughout the study; HBcAb positive with HBV DNA <2000 IU/mL (<104/mL) require regular monitoring of HBV DNA quantification throughout the study); Hepatitis C virus (HCV) antibody positive with peripheral blood HCV RNA ≥103 IU/mL; Human immunodeficiency virus (HIV) antibody positive; Active syphilis infection (cured cases may be included); Cytomegalovirus (CMV) DNA positive; Positive nucleic acid test for novel coronavirus (COVID-19).
- •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 virus vaccines within the past 6 months or planned to receive live virus 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.
- •Previous history of pancreatic cancer, intraductal papillary mucinous neoplasm of the pancreas, end-stage lung disease, or liver cirrhosis.
- •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.
排除标准
- 未提供
结局指标
主要结局
C-peptide change
时间窗: 12 months post-transplant
Evaluation of the magnitude of C-peptide change after transplantation
次要结局
- Glycemic control (MAGE)(12 weeks and 52 weeks post-transplant)
- the proportion of subjects with HbA1c ≤7.0% and no severe hypoglycemic events(52 weeks post-transplant)
- The proportion of subjects who are insulin-independent(12 weeks and 52 weeks post-transplant)
- The percentage reduction in insulin requirement(12 weeks and 52 weeks post-transplant)
- Evaluation of the severity of hypoglycemia using the Ryan Hypoglycemia Severity Score (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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