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Study of NRTX-1001 Neural Cell Therapy in Drug-Resistant Unilateral Mesial Temporal Lobe Epilepsy (EPIC (EPIlepsy Cell Therapy))
Sponsor: Neurona Therapeutics
Summary
This clinical trial is designed to test whether a single image-guided intracerebral administration of inhibitory nerve cells, called interneurons (NRTX-1001), into subjects with drug-resistant unilateral mesial temporal lobe epilepsy (MTLE), with or without mesial temporal sclerosis (MTS), is safe (frequency of adverse events) and effective (seizure frequency). NRTX-1001 comprises human interneurons that secrete a neurotransmitter, gamma-aminobutyric acid (GABA).
Official title: A Study of Inhibitory Interneurons (NRTX-1001) in Drug-Resistant Unilateral Mesial Temporal Lobe Epilepsy (MTLE)
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
88
Start Date
2022-06-16
Completion Date
2043-09
Last Updated
2026-03-30
Healthy Volunteers
No
Conditions
Interventions
NRTX-1001
Biological: NRTX-1001 is an experimental neural cell therapy product candidate derived from an allogeneic human embryonic stem cell line. The stem cells were converted into inhibitory nerve cells that produce GABA.
NRTX-1001
Biological: NRTX-1001 is an experimental neural cell therapy product candidate derived from an allogeneic human embryonic stem cell line. The stem cells were converted into inhibitory nerve cells that produce GABA.
Sham Comparator
Sham Comparator
Locations (33)
Mayo Clinic Arizona Epilepsy Center
Phoenix, Arizona, United States
Banner-University of Arizona Medical Center Tucson Comprehensive Epilepsy Program
Tucson, Arizona, United States
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States
University of Southern California Keck Hospital
Los Angeles, California, United States
University of California Los Angeles
Los Angeles, California, United States
UC Irvine Medical Center
Orange, California, United States
Stanford University
Palo Alto, California, United States
University of California Davis
Sacramento, California, United States
University of California San Diego
San Diego, California, United States
University of California San Francisco
San Francisco, California, United States
University of Colorado Anschutz Medical Campus
Aurora, Colorado, United States
George Washington University
Washington D.C., District of Columbia, United States
University of Miami
Miami, Florida, United States
Rush University Medical Center
Chicago, Illinois, United States
University of Chicago
Chicago, Illinois, United States
University of Iowa Health Care
Iowa City, Iowa, United States
Ochsner Clinic Foundation
New Orleans, Louisiana, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Wayne State University/Detroit Medical Center Comprehensive Epilepsy Program
Detroit, Michigan, United States
Dartmouth Hitchcock Medical Center/ Department of Neurology
Lebanon, New Hampshire, United States
Hofstra Northwell Comprehensive Epilepsy Center
Great Neck, New York, United States
NYU Langone Comprehensive Epilepsy Center
New York, New York, United States
SUNY Upstate Medical University
Syracuse, New York, United States
Atrium Health
Charlotte, North Carolina, United States
Duke University Hospital
Durham, North Carolina, United States
Atrium Wake Forest Baptist
Winston-Salem, North Carolina, United States
Oregon Health and Science University
Portland, Oregon, United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States
UT Southwestern Medical Center
Dallas, Texas, United States
UTHealth Houston
Houston, Texas, United States
University of Utah Health
Salt Lake City, Utah, United States
University of Washington Regional Epilepsy Center
Seattle, Washington, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States