NCT01974674Unknown2 期
Allogeneic Islet Transplantation for the Treatment of Type 1 Diabetes
适应症
试验速览
- 阶段
- 2 期
- 入组人数
- 19
- 试验地点
- 2
- 主要终点
- restoration of normal glycemic control without insulin
研究概览
简要总结
It is a multicentre, sequential, phase II clinical trial, aiming at evaluating the allogeneic islet transplantation for the treatment of type 1 diabetes.
19 patients with type 1 diabetes will be included and ideally distributed evenly: patients with unstable diabetes without renal insufficiency (AI group for "islet alone" by the international customary determination) and patients with a functioning kidney transplant (IAK group for "islet after kidney"). The main endpoint will be defined by the restoration of normal glycemic control without insulin at 6 months after graft.
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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with type 1 diabetes
- •18 <Age <55 years
- •Plasma C-peptide <0.2 ng/ml basal and stimulated glucagon
- •Evolution of diabetes for more than 5 years
- •Regular patient follow-up (> or equal to 2 visits per year from the same diabetologist)
- •Patient who received the information and have given their consent in writing
- •Absence of HIV, hepatitis B and hepatitis C, HTLV-1-2
- •ABO compatibility with the donor
- •Cross match negative
- •Anti-HLA antibodies (class I and / or class II) detected by lymphocytotoxicity <20%
- •PCR negative for the BK virus in the blood (so as not to amplify the BK virus replication with the ATG).
- •Accepting patients effective contraception during the study period
- •For patients in group IA
- •Glomerular filtration rate estimated by the MDRD> 50 ml/min/1.73m2
- •No perception of hypoglycaemia (less than 0.54 mg/dl glucose) at least one value documented in the two years preceding and/or
- •Occurrence of at least one severe hypoglycemic episode (with a third required) and unexplained in the two years before and/or at least two episodes of ketoacidosis per year
- •Average HbA1c> 8.5% over two years, despite intensified treatment (basal pattern, bolus)
- •For patients in the IAK
- •functional renal graft for at least 1 year
- •glomerular filtration rate> 50 ml/min/1.73 m2
- •proteinuria <0.5 g/day
- •Absence of acute rejection in renal previous 6 months
排除标准
- •BMI > 28
- •Need insulin > 1 U/kg per day
- •Pregnancy, lactation
- •Intention of childbearing for the two sexes
- •Psychiatric Disorders
- •Inability to communicate or cooperate with the investigator
- •Lack of therapeutic compliance, including HbA1C > 12%
- •Chronic liver disease
- •Progressive heart disease myocardial infarction within 6 months prior to inclusion, unbalanced CHD)
- •Proliferative retinopathy unstabilized
- •History of cancer, whatever the date, except for basal or squamous cell skin cancers over 1 year.
- •Systemic infection
- •Chronic high risk of requiring corticosteroids
- •Need for long-term corticosteroid, outside that specified in renal transplantation, the patients will be weaned before transplantation
- •Anticoagulant vitamin K or antiplatelet treatments
- •Disorders of hemostasis TP <60 % TCA > 1.5 times the control
- •Anti-HLA antibodies ( class I and/or class II ) detected by lymphocytotoxicity > 20%
- •Platelets < 100 giga/L and/or neutrophils <1.5 giga/L
- •Chronic intoxication by alcohol, tobacco, or other substance (abstinence > 6 months required)
- •Active infection by hepatitis B, hepatitis C and HIV, HTLV-1-HTLV2
结局指标
主要结局
restoration of normal glycemic control without insulin
时间窗: 6 months after graft
the restoration of normal glycemic control without insulin therapy will be evaluated by measuring - A fasting glucose (\> 8 hours) less than 1.25 g/L and a 2 hours glucose after oral intake of 75g of glucose, less than 2 g/L in a patient without insulin for at least 15 consecutive days during the the first 6 months from day 0.
次要结局
- potential of each infusion of islets(within 2 years after inclusion)
- Obtaining a remission of diabetes(within 2 years after inclusion)
- Decrease in the frequency, severity or poor perception of hypoglycaemia defined Hypo score(within the 2 years after inclusion)
- term graft survival(within 2 years of inclusion)
- Restoration of normal glycemic control without insulin for a year(1 year)
- Obtaining an improvement in glycemic control(within 2 years after inclusion)
- quality of life(within 2 years after inclusion)
- beta-cell function(2 years)
- Improved metabolic profile determined by the OGTT and hyperglycemic clamp(within 2 years after inclusion)
- Decreased glycemic variability(within 2 years after inclusion)
- Reduction of oxidative stress assessed by the urinary excretion of 24 hours of 8-iso-PGF2 rates.(within 2 years after inclusion)
- degenerative complications of diabetes(2 years)
研究者
研究点 (2)
Loading locations...
相似试验
招募中
不适用
Allogeneic Regenerative Islet Transplantation for the Treatment of Brittle Type 1 Diabetes MellitusBrittle Type 1 Diabetes MellitusNCT06196996Shanghai Changzheng Hospital18
已完成
不适用
Islet Cell Transplantation in Patients With Type I Diabetes With Previous Kidney TransplantationOrgan TransplantationImmunosuppressionType 1 DiabetesNCT01123187University Hospital, Lille14
撤回
不适用
Pancreatic Islet Transplantation to the Anterior Chamber of the EyeVisual ImpairmentType 1 DiabetesNCT04198350Imperial College London6
Unknown
1 期
Islet Transplant in Patients With Type I DiabetesDiabetes Mellitus, Type 1NCT03698396Kenneth Brayman, MD10
Unknown
不适用
Autologous Regenerative Islet Transplantation for Insulin-dependent DiabetesDiabetesNCT05294822Shanghai Changzheng Hospital20