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临床试验/EUCTR2014-004110-28-IT
EUCTR2014-004110-28-IT进行中（未招募）不适用

A monocentric, open-label pilot study to assess the safety and efficacy of minimal islet transplantation in patients with new-onset type 1 diabetes. - MITO Trial

IRCCS Ospedale San Raffaele0 个研究点目标入组 6 人开始时间: 2014年12月22日最近更新:
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适应症
相关药物

试验速览

阶段
不适用
状态
进行中（未招募）
发起方
入组人数
6
研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

性别
All

入选标准

  • •Males and females aged 18-45 years
  • •- Ability to provide written informed consent
  • •- Mentally stable and able to comply with the procedures of the Protocol for the duration of the study, including follow-up visits and examinations scheduled
  • •- T1D new onset (diagnosis of diabetes within 180 days prior to enrollment).
  • •- Function beta cell residual (C-peptide fasting> 0.3 ng / mL in plasma glucose levels> 70 mg / dL and =200 mg / dL).
  • •- Positivity for at least one of the following autoantibodies typically associated with T1D: anti-GAD, anti-IA-2, anti ZnT8, IAA. A person who is positive for IAA and negative for other autoantibodies is not admissible if used insulin for more than 7 days.
  • •- Ongoing treatment with insulin, or has required insulin therapy (for 7 days) for diabetes at some time between the date of diagnosis and recruitment
  • •- Incompatibility for MHC class IA and B and compatibility for MHC class II DR with the donor of islet
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range:
  • •F.1.2 Adults (18-64 years) yes
  • •F.1.2.1 Number of subjects for this age range 6
  • •F.1.3 Elderly (>=65 years) no
  • •F.1.3.1 Number of subjects for this age range

排除标准

  • •- Body mass index (BMI) = 32.0 kg / m2 or patient = 50kg weight
  • •- Requirement of insulin> 1.0 IU / kg / day
  • •- HbA1c> 10%
  • •- Blood pressure: systolic> 160 mmHg or diastolic blood pressure> 100 mmHg.
  • •- Chronic disease than type 1 diabetes.
  • •- Moderate and severe renal impairment (creatinine clearance <90 mL / min)
  • •- Presence or history of macroalbuminuria (> 300 mg / g creatinine).
  • •- Hepatic dysfunction defined by an increase in ALT / AST above the limit of the normal value and increases in total bilirubin> 3 mg / dl
  • •- Pregnant or breast-feeding.
  • •- Reluctance to use effective contraception up to 4 months after the end of the administration of the study drug (females and males)
  • •- Active infection including hepatitis B, hepatitis C, HIV or tuberculosis (TB). Positive tests are acceptable only if associated with a history of previous vaccination in the absence of any sign of active infection.
  • •- Negative for Epstein-Barr Virus (EBV) to the determination of IgG
  • •- Invasive aspergillosis, histoplasmosis, coccidioidomycosis year prior to study enrollment
  • •- Any history of malignancy except basal or squamous cell carcinoma of the skin eradicated
  • •- Alcohol or substance abuse known active
  • •- Haemoglobin base below the lower limit of normal; lymphopenia (<1,000 / microL), neutropenia (<1,500 / microL), or thrombocytopenia (platelets <100,000 / microL).
  • •- A history of lack of factor V
  • •- Any coagulopathy or diseases requiring long-term anticoagulant therapy (eg, warfarin) after transplantation (treatment with low-dose aspirin is permitted) or patients with an international normalized ratio (INR)> 1.5
  • •- Heart Disease serious coexisting:
  • •recent myocardial infarction (within the last 6 months)
  • •left ventricular ejection fraction <30%
  • •- Calculus symptomatic gallbladder
  • •- Acute or chronic pancreatitis
  • •- Peptic ulcer symptomatic
  • •- Severe diarrhea incessant vomiting or other gastrointestinal disorders potentially interfering with the ability to absorb oral medications
  • •- Hyperlipidemia despite medical therapy (fasting low-density lipoprotein [LDL] cholesterol> 130 mg / dL, treated or untreated, and or fasting triglycerides> 200 mg / dL)
  • •- Treatment for a medical condition requiring chronic use of systemic steroids, except for the use of 5 mg of prednisone per day, or an equivalent dose of hydrocortisone, for the replacement saline.
  • •- Treatment with any anti-diabetic drug other than insulin within 4 weeks of enrollment
  • •- Use of investigational drugs within 4 weeks of enrollment.
  • •- The administration of live attenuated vaccine within 2 months thereafter
  • •- Any medical condition that, in the opinion of the investigator, would interfere with the safe participation in the study.
  • •- Treatment with any immunosuppressive regimen at enrollment

研究者

发起方
IRCCS Ospedale San Raffaele

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