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RECRUITING
NCT05135091
PHASE3

Study of NRTX-1001 Neural Cell Therapy in Drug-Resistant Unilateral Mesial Temporal Lobe Epilepsy (EPIC (EPIlepsy Cell Therapy))

Sponsor: Neurona Therapeutics

View on ClinicalTrials.gov

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

Interventions

BIOLOGICAL

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.

BIOLOGICAL

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.

PROCEDURE

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