Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004471
Status:
COMPLETED
Last Update Posted:
2011-03-29
First Post:
1999-10-18
Brief Title:
Phase I Pilot Study of Gene Therapy for Cystic Fibrosis Using Cationic Liposome Mediated Gene Transfer
Sponsor:
University of Alabama at Birmingham
Organization:
University of Alabama at Birmingham
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2011-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 DMRIEDOPE mediated gene transfer
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 DMRIEDOPE mediated gene transfer
Detailed Description:
PROTOCOL OUTLINE Under direct visualization patients receive lipidDNA 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| UAB-F930923001 | None | None | None |
| UAB-6097 | None | None | None |