Phase I Pilot Study of Gene Therapy for Cystic Fibrosis Using Cationic Liposome Mediated Gene Transfer
|ClinicalTrials.gov Identifier: NCT00004471|
Recruitment Status : Completed
First Posted : October 19, 1999
Last Update Posted : March 29, 2011
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.
|Condition or disease||Intervention/treatment||Phase|
|Cystic Fibrosis||Genetic: pGT-1 gene lipid complex||Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||9 participants|
|Study Start Date :||August 1995|
|Primary Completion Date :||May 2001|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00004471
|Study Chair:||Eric J. Sorscher||University of Alabama at Birmingham|