Phase I Pilot Study of Gene Therapy for Cystic Fibrosis Using Cationic Liposome Mediated Gene Transfer

University of Alabama at Birmingham0 个研究点目标入组 9 人开始时间: 1995年8月最近更新: 2011年3月29日

适应症

试验速览

阶段: 1 期
状态: 已完成
发起方: University of Alabama at Birmingham
入组人数: 9

研究概览研究设计入排标准研究者记录与标识符相似试验

研究概览

简要总结

OBJECTIVES:

Determine whether copies of the cystic fibrosis gene (pGT-1) can be delivered to the cells lining the nose of cystic fibrosis patients using cationic liposome (DMRIE/DOPE) mediated gene transfer.

详细描述

PROTOCOL OUTLINE: Under direct visualization, patients receive lipid/DNA formulation (pGT-1 lipid complex) by syringe instillation over 30 minutes to the right inferior nasal turbinate.

Patients are followed daily for 7 days, twice a week for 3 weeks, every 2-3 weeks for 10 weeks, then every 3 months thereafter.

研究设计

研究类型: Interventional
主要目的: Treatment

入排标准

年龄范围: 16 Years 至 —（Child, Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

未提供

排除标准

未提供

研究者

发起方

University of Alabama at Birmingham

申办方类型

Other

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