Completed
Phase I Pilot Study of Gene Therapy for Cystic Fibrosis Using Cationic Liposome Mediated Gene Transfer
What is being tested
pGT-1 gene lipid complex
Genetic
Who is being recruted
Digestive System Diseases+9
+ Infant, Newborn, Diseases
+ Lung Diseases
Over 16 Years
How is the trial designed
Treatment Study
Phase 1
Interventional
Study Start: August 1995
Summary
Principal SponsorUniversity of Alabama at Birmingham
Last updated: March 29, 2011
Sourced from a government-validated database.Claim as a partner
Study start date: August 1, 1995
Actual date on which the first participant was enrolled.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.
Principal SponsorUniversity of Alabama at Birmingham
Last updated: March 29, 2011
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
9 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Conditions
Criteria
Any sex
Biological sex of participants that are eligible to enroll.Over 16 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Digestive System DiseasesInfant, Newborn, DiseasesLung DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesPancreatic DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsDisease AttributesCystic FibrosisRespiratory Tract DiseasesGenetic Diseases, InbornRare Diseases
Criteria
Cystic fibrosis patients Not pregnant Fertile patients must use effective contraception
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has no location dataSave this study to your profile to know when the location data is available.
CompletedNo study centers