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临床试验/NCT00038116
NCT00038116已完成3 期

Embryonic Dopamine Cell Implants for Parkinson's Disease: A Double-Blind Study

University of Colorado, Denver5 个研究点 分布在 1 个国家目标入组 40 人开始时间: 1995年5月最近更新:
适应症

试验速览

阶段
3 期
状态
已完成
入组人数
40
试验地点
5
主要终点
a subjective Global Rating Scale

研究概览

简要总结

The purpose of this trial is to determine if patients who received embryonic dopamine cell implant surgery showed significantly greater improvement in their Parkinson's disease than a control group undergoing the placebo treatment, and to determine if the cell implant surgery was more effective in younger or older patients.

详细描述

Parkinson's disease is caused by the death of a small number of nerve cells that produce a critical chemical called dopamine. The drug L-dopa can partially make up for the lack of dopamine. As time goes on, however, most patients notice that the drugs do not work as well. Oftentimes, patients develop great fluctuations in motor control. Off drugs they cannot move, and on drugs they have excess, exaggerated movements. Research in animals over the last 20 years has shown that dopamine cells can be replaced by transplants of new cells obtained from fetal brain tissue. For the past 14 years, several laboratories around the world have been performing similar transplants of human fetal brain tissue on patients with Parkinson's disease. So far, it has been impossible to compare results from the different groups because no two centers are performing transplants in the same way.

This study seeks to get around that problem using a controlled clinical trial that compares the embryonic dopamine cell implant surgery with a placebo treatment. A total of 40 patients were recruited--half received the cell implant surgery, while the other half received the placebo. After the double-blind phase of the study, patients in the placebo group had the option of receiving tissue implants. Fourteen of these patients eventually had transplants. At present, this study is providing long-term follow-up evaluation and treatment for the subjects.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Double (Participant, Investigator)

入排标准

年龄范围
20 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

a subjective Global Rating Scale

时间窗: duration of the trial

次要结局

  • objective measurements of PD, including UPDRS motor "off", Schwab and England "off", and 19F-fluorodopa uptake(duration of the trial)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (5)

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