Alemtuzumab Induction With Tacrolimus and MMF Maintenance Immunosuppression in Islet Transplantation
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 2
研究概览
简要总结
Our experience suggests that further research with alemtuzumab is attractive in islet transplantation. Therefore, in this study we propose to combine alemtuzumab induction pre-transplant, with tacrolimus and mycophenolate mofetil maintenance immunosuppression post-transplant. In the critical early phase post transplant, we anticipate that this regimen will prove to be more effective in control of autoimmunity or rejection events, and have a more desirable side-effect profile, than previously tested combinations of induction and immunosuppressive agents.
详细描述
This trial is a single-center, prospective, open-label study in 12 Type 1 diabetic participants receiving an islet-alone transplant along with alemtuzumab induction therapy followed by combination tacrolimus and MMF maintenance immunosuppression. Participants will receive 1 to 3 infusions of pancreatic islets of sufficient quantity to attain insulin independence.
The primary objective of this protocol is to assess the safety of a treatment regimen utilizing alemtuzumab induction and a combination of tacrolimus and MMF maintenance immunosuppression in adult Type 1 diabetic participants receiving their first islet transplant.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •open to Canadians only
- •participant must have had Type 1 diabetes mellitus for more than 5 years
- •diabetes must be complicated by at least 1 of the following situations that persist despite intensive insulin management efforts: (1) Reduced awareness of hypoglycemia, as defined by the absence of adequate autonomic symptoms at plasma glucose levels < 3.0 mmol/L, indicated by, 2 or more episodes of severe hypoglycemia requiring third party assistance within 12 months; or (2) Metabolic instability, characterized by erratic blood glucose levels that interfere with daily activities and or 2 or more hospital visits for diabetic ketoacidosis over the last 12 months.
- •Participants must be capable of understanding the purpose and risks of the study and must sign a statement of informed consent.
排除标准
- •Severe co-existing cardiac disease
- •Active alcohol or substance abuse, to include cigarette smoking
- •Psychiatric disorder making the subject not a suitable candidate for transplantation
- •History of non-adherence to prescribed regimens
- •Active infection including Hepatitis C, Hepatitis B, HIV, TB
- •Any history of or current malignancies except squamous or basal skin cancer
- •BMI > 28 kg/m2 at screening visit
- •Creatinine clearance < 65 mL/min/1.73 m2
- •Blood creatinine > 150 µmol/L (1.7 mg/dL)
- •Macroalbuminuria (urinary albumin excretion rate > 300 mg/24h)
- •Baseline Hb < 105g/L (<10.5 g/dL) in women, or < 130 g/L (<13 g/dL) in men
- •Baseline screening liver function tests outside of normal range
- •Untreated proliferative retinopathy
- •Positive pregnancy test, intent for future pregnancy or male subjects' intent to procreate, failure to follow effective contraceptive measures, or presently breast feeding
- •Previous transplant, or evidence of significant sensitization on PRA
- •Insulin requirement >1.0 U/kg/day
- •HbA1C >12%
- •Uncontrolled hyperlipidemia
- •Under treatment for a medical condition requiring chronic use of steroids
- •Use of coumadin or other anticoagulant therapy (except aspirin) or subject with PT INR > 1.5
- •Untreated Celiac disease
- •Patients with Graves disease will be excluded unless previously adequately treated with radioiodine ablative therapy