Safety and Tolerability Study of ST-503 for Refractory Pain Due to Peripheral Neuropathy (Small Fiber Predominant, SFN)
Start Date
12/4/2025
Completion Date
7/1/2028
Summary
This research is being done to study a possible treatment for refractory pain due to small fiber neuropathy (SFN). ST-503 is intended to deliver a modified copy of the gene which will ideally repress Nav1.7 tissue-related pain signals reaching the brain, which should reduce the refractory pain due to small fiber neuropathy (SFN).
Detailed Description
This research is being done to study a possible treatment for refractory pain due to small fiber neuropathy (SFN). Small fiber neuropathy happens when something damages small nerve fibers in your skin, causing symptoms like painful tingling or burning sensations in your hands and feet. Pain originating in the nerves outside of the brain and spinal cord is defined by doctors as neuropathic pain. Scientists have discovered that certain proteins in our bodies called sodium channels are important for communicating pain signals in nerves, specifically, Nav1.7, Nav1.8 and Nav1.9. This first-in-human study will test the use of a type of experimental treatment called "gene therapy." The primary goal is to determine if it is safe and well tolerated. The second goal is to determine if it reduces the level of refractory pain due to SFN disease. The gene will be delivered into your cells using a special delivery tool called a vector.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
ST-503
Sham (No Treatment)
Conditions
Locations
HonorHealth
Scottsdale, Arizona 85260
United States
University of Arkansas for Medical Sciences
Little Rock, Arkansas 72205
United States
The University of California, San Diego
La Jolla, California 92093
United States
Johns Hopkins University
Baltimore, Maryland 21218
United States
Massachusetts General Hospital
Boston, Massachusetts 02114
United States
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire 03766
United States
Columbia University Irving Medical Center (CUIMC) and New York-Presbyterian Hospital (NYPH)
New York, New York 10027
United States
University of North Carolina Medical Center
Chapel Hill, North Carolina 27514
United States
Vanderbilt University
Nashville, Tennessee 37235
United States
University of Utah
Salt Lake City, Utah 84112
United States
Virginia Commonwealth University
Richmond, Virginia 23284
United States