CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 16 enrolled
Drug / intervention
Retrograde high pressure transvenous perfusion with normal salineother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00873782
NCT00873782Phase 1Completed
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Safety and Feasibility of Transvenous Limb Perfusion With Normal Saline in Human Muscular Dystrophy

University of North Carolina, Chapel Hill·interventional·Posted Apr 2, 2009·Updated Mar 9, 2015

In Brief

A Phase 1 clinical trial evaluating Retrograde high pressure transvenous perfusion with normal saline for Muscular Dystrophies and 3 related conditions. Completed, enrolled 16 participants across 1 site.

Detailed Summary

Muscular dystrophies are inherited disorders in which the skeletal and heart muscles become progressively weaker, sometimes leading to permanent disability. Current treatments aim to control symptoms as much as possible, but there is no cure. Gene therapy, in which defective genes causing the disorder are corrected, is a potential treatment option and is in the process of being developed for muscular dystrophies. This study will determine the safety and feasibility of a particular delivery method for gene therapy that could be used in the future to treat people with muscular dystrophies. Only normal saline, and no active treatment, will be used in this study.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMuscular Dystrophies, Duchenne Muscular Dystrophy, Becker Muscular Dystrophy, Limb-Girdle Muscular Dystrophy
CountriesUnited States
CollaboratorsNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), University of North Carolina

Timeline

Phase 1CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedApr 2, 2009
Enrollment StartMar 1, 2009
Primary CompletionFeb 1, 2014
TodayJul 2, 2026
Enrollment to primary: 4.9 yearsPosted 17.3 years ago

Interventions

Retrograde high pressure transvenous perfusion with normal salineother

Dose escalation of saline volume, infusion rate, and tourniquet pressure, as determined in a stepwise manner and by careful monitoring