An Open Label, Pilot Investigation, to Assess the Safety and Efficacy of Transplantation of Macro-encapsulated Human Islets Within the Bioartificial Pancreas Beta-Air in Patients With Type 1 Diabetes Mellitus

Uppsala University Hospital2 个研究点分布在 1 个国家目标入组 4 人2014年2月1日

适应症Long-standing Type 1 Diabetes Mellitus

干预措施Beta-Air device for encapsulation of transplanted human islets

概览

阶段: 1 期
干预措施: Beta-Air device for encapsulation of transplanted human islets
疾病 / 适应症: Long-standing Type 1 Diabetes Mellitus
发起方: Uppsala University Hospital
入组人数: 4
试验地点: 2
主要终点: Safety of device, as evaluated by incidence of adverse events or serious adverse events judged probable or highly probable related to the device
状态: 进行中（未招募）
最后更新: 4天前

概览研究者入排标准研究组 & 干预措施结局指标研究点相似试验

概览

简要总结

The primary objective of this clinical investigation is to investigate the safety of implantation of the human islet containing device Beta-Air in type 1 diabetic subjects.

The secondary objective of this clinical investigation is to investigate if the transplantation of macro-encapsulated human islets within the Beta-Air device can provide improved glycaemic control in type 1 diabetes patients with reduced incidences of hypoglycaemic episodes.

注册库

clinicaltrials.gov

开始日期

2014年2月1日

结束日期

2027年5月1日

最后更新

4天前

研究类型

Interventional

研究设计

Single Group

性别

All

研究者

发起方

Uppsala University Hospital

责任方

Principal Investigator

主要研究者

Per-Ola Carlsson

Professor

Uppsala University Hospital

入排标准

入选标准

•Informed consent obtained before any investigation-related activities. Investigation-related activities are any procedure that would not have been performed during normal management of the subject.
•Diagnosis of type 1 diabetes mellitus for \> 5 years
•Men or women \> 18 years of age at the time of enrolment
•Involvement in intensive diabetes management defined as self-monitoring of blood glucose level no less than a mean of three times per day averaged over each week and by the administration of three or more insulin injections per day or insulin pump therapy. This management must be under the direction of a diabetologist or diabetes specialist during the 12 months prior to study enrolment.

排除标准

•Body mass index (BMI) \> 30 kg/m²
•Insulin requirement of \> 1.0 Units/kg/day
•HbA1c \> 10 % (DCCT)
•Random C-peptide \> 0.003 nmol/l
•Known untreated active proliferative diabetic retinopathy changes or increasing macular oedema
•Renal failure (Glomerular Filtration Rate \<60 ml/min)
•Women of childbearing potential who are pregnant, breast-feeding or intend to become pregnant or unwilling to use adequate contraceptive methods for the duration of the trial (implants, injectables, combined oral contraceptives, hormonal intrauterine device, sexual abstinence or vasectomised partner).
•Active infection including hepatitis B, hepatitis C, HIV, Tbc
•Any history of malignancy except for completely resected squamous or basal cell carcinoma of the skin
•Known active alcohol or drug abuse.

研究组 & 干预措施

Human islets in Beta-Air device

干预措施: Beta-Air device for encapsulation of transplanted human islets

结局指标

主要结局

Safety of device, as evaluated by incidence of adverse events or serious adverse events judged probable or highly probable related to the device

时间窗: 0-365 days

次要结局

3. Signs of immunization in transplanted patients.(0-365 days)
2. Incidence and severity of fibrosis surrounding the device during course of study.(0-365 days)
6. Numbers of patients with peak c-peptide >0.20 nmol/l, in response to the mixed meal tolerance test at 12 and 26 weeks post-transplantation(12 and 26 weeks post-transplantation)
1. Incidence of local or systemic inflammation or infection, incl. C-reactive protein rise, judged related to the device during course of study.(0-365 days)
7. C-peptide area under the curve in response to the mixed meal tolerance test at 12 and 26 weeks post-transplantation.(12 and 26 weeks post-transplantation)
5. Survival of endocrine tissue in the device, as evaluated by [11C]-5-hydroxytryptophane positron emission tomography and histological analysis at 26 weeks post-transplantation.(0-180 days)
8. Number of patients with non-fasting c-peptide concentrations >0.003 nmol/l at 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24 and 26 weeks post-transplantation; i.e. Kaplan-Meier analysis of survival time for islet grafts.(0-26 weeks)
4. Oxygenation of tissue in the device, as evaluated at 4, 12 and 26 weeks post-transplantation(0-180 days)