EUCTR2005-004523-19-ES进行中（未招募）不适用
Phase II clinical trial to evaluate the efficacy and safety in the use of pancreatic islets cells from cadaver donors for the treatment of Type-I Diabetes Mellitus in renal transplant patients.
Área de Trasplante y Terapia Celular - Hospital Central de Asturias0 个研究点目标入组 10 人开始时间: 2010年3月15日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 10
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
- •. Type-I diabetes mellitus patients with renal transplantation and good renal function (serum creatinine < 2 mg/dl, creatinine clearance > 40 ml/min and proteinuria < 1 gr/day).
- •. Patients who were indicated a renal but not a pancreas transplantation because of the high-risk for surgery. For these patients renal and pancreatic islet cells transplant will be performed at the same time.
- •. Patients between 18 and 65 years of age.
- •. C-peptide levels < 0.48 ng/ml.
- •. Body Mass Index (BMI) < 28 kg/m2
- •. Time of renal transplantantion of at least 6 months.
- •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
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •. Deliberate desire not to take part in the trial.
- •. Negative to sign the informed consent, essetial to take part in the Trial.
- •. Presence of higher cardiovascular risks: ischemic cardiopathy, peripheral vasculopathy (amputation and/or intermittent claudication) and left ventricular dysfunction (LVEF left ventricular ejection fraction <30%).
- •. Consumption of alcohol or any other substance abuse, including tobacco (abstinence is required for a period of at least 6 months).
- •. Active infections (hepatitis B and C, HIV, tuberculosis, etc.).
- •. Presence of neoplasia within 5 years prior to the transplantation, excluding nonmelanoma skin carcinomas.
- •. Hepatic disease or hepatic disorders (ie. portal hypertension detected by ecographic control).
- •. Presence of motor neuropathy or autonomic impairment.
- •. Presence of coagulation disorders.
- •. Presence of Leukopenia <3000/mm3 or thrombopenia <100.000/mm3.
- •. Renal failure (creatinine clearance <60 ml/min or macroalbuminuria), except when performed together with the renal transplant.
- •. Non-treated proliferative retinopathy .
- •. Women who are pregnant or breast-feeding, or women with child-bearing potential who are not using effective contraceptive methods.
- •. Daily insulin requirement > 0.7 U/kg/day.
- •. HbA1c > 12%.
- •. Uncontrolled hyperlipidemia.
- •. Any other medical situation which in the investigator’s opinion could interfere with optimum participation in the trial or cause significant risk for the patient.
研究者
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