Phase I Pilot Study of Gene Therapy for Cystic Fibrosis Using Cationic Liposome Mediated Gene Transfer
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|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|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00004471
|Study Chair:||Eric J. Sorscher||University of Alabama at Birmingham|