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临床试验/ACTRN12609000192280
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Safety and Function of Encapsulated Human Islets Transplanted Into People With Diabetes

South Eastern Sydney Illawarra Area Health Service0 个研究点目标入组 6 人开始时间: 2009年4月20日最近更新:
适应症

试验速览

阶段
未知
状态
已完成
发起方
入组人数
6

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional
分配方式
Non-randomised trial
主要目的
Treatment
盲法
Open (masking not used)

入排标准

年龄范围
18 Years 至 50 Years(—)
性别
All

入选标准

  • normal body weight, that is, body mass index < 30, but ideally <25.
  • (b) age 18-50 years
  • (c) no insulin production from their pancreas
  • (d) (i) difficulty in controlling blood glucose levels despite compliance with insulin injections, physical activity and food intake. This difficulty is impacting on the quality of life.
  • (ii) unable to recognise the symptoms of low blood glucose levels for whom no other strategy has been successful.
  • (iii) special situations, e.g., rapid falls in blood glucose levels resulting in epilepsy and where anti-epileptic medication is unsuitable.
  • Each case will be considered on its merit, but the benefit must exceed the risk.

排除标准

  • 1. Does not fit the above criteria.
  • 2. Residual function of recipient’s pancreatic beta cells, as assessed by C-peptide production.
  • 3. Body mass index > 30.
  • 4. Pregnancy.
  • 5. Non-agreement by patient’s endocrinologist.

研究者

发起方
South Eastern Sydney Illawarra Area Health Service

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