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

Plain-language summary

This Phase 1 pilot study at the University of Alabama at Birmingham aimed to determine whether copies of the cystic fibrosis gene (pGT-1) could be delivered to the cells lining the nose of cystic fibrosis patients using cationic liposome (DMRIE/DOPE) mediated gene transfer. Participants were cystic fibrosis patients who were not pregnant, with fertile patients required to use effective contraception. The trial is completed.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

Phase 1

Status

Completed

Sponsor

University of Alabama at Birmingham

Intervention

pGT-1 gene lipid complex

Start date

8/1/1995

Related genes

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

* Cystic fibrosis patients
* Not pregnant Fertile patients must use effective contraception