Actively Recruiting
Study of NRTX-1001 Neural Cell Therapy in Drug-Resistant Unilateral Mesial Temporal Lobe Epilepsy (EPIC (EPIlepsy Cell Therapy))
Led by Neurona Therapeutics · Updated on 2026-03-30
88
Participants Needed
33
Research Sites
1106 weeks
Total Duration
On this page
Sponsors
N
Neurona Therapeutics
Lead Sponsor
C
California Institute for Regenerative Medicine (CIRM)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
Study of NRTX-1001 Neural Cell Therapy in Drug-Resistant Unilateral Mesial Temporal Lobe Epilepsy (EPIC (EPIlepsy Cell Therapy))
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or Female, age 2 to 2 75 years
- Diagnosed with unilateral mesial temporal lobe epilepsy (MTLE) causing focal seizures
- Failed to control seizures after trying at least 2 anti-seizure drugs at proper doses
- Stable doses of approved anti-seizure drugs for at least 1 month before screening
- Single seizure focus confirmed in one hippocampus
- Seizure frequency averaging 4 or more per 28 days, including 2 or more clinical focal seizures with clear signs over 6 months prior (Phase 1/2 only)
- Disabling seizure frequency of 2 or more per 28 days averaged over 3 months before screening and a 10-week baseline before randomization (Phase 3 only)
You will not qualify if you...
- Epilepsy caused by other medical conditions or progressive neurologic diseases
- Seizure focus outside the hippocampus or seizures not focal in origin
- Significant other medical conditions that would make participation unsafe
- History of status epilepticus in the 3 years before screening
- Primary or secondary immunodeficiency
- Suicide attempts within the past 3 years
- Severe psychiatric disorders
- Previous lobectomy or laser interstitial thermal therapy (LITT) procedure
- MRI showing possible malignant brain lesion
- Pregnancy or currently breastfeeding
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 33 locations
1
Mayo Clinic Arizona Epilepsy Center
Phoenix, Arizona, United States, 85054
Actively Recruiting
2
Banner-University of Arizona Medical Center Tucson Comprehensive Epilepsy Program
Tucson, Arizona, United States, 85724-5023
Actively Recruiting
3
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
Actively Recruiting
4
University of Southern California Keck Hospital
Los Angeles, California, United States, 90033
Actively Recruiting
5
University of California Los Angeles
Los Angeles, California, United States, 90095
Actively Recruiting
6
UC Irvine Medical Center
Orange, California, United States, 92868
Actively Recruiting
7
Stanford University
Palo Alto, California, United States, 94304
Actively Recruiting
8
University of California Davis
Sacramento, California, United States, 95817
Actively Recruiting
9
University of California San Diego
San Diego, California, United States, 92037
Actively Recruiting
10
University of California San Francisco
San Francisco, California, United States, 94143
Actively Recruiting
11
University of Colorado Anschutz Medical Campus
Aurora, Colorado, United States, 80045
Actively Recruiting
12
George Washington University
Washington D.C., District of Columbia, United States, 20037
Actively Recruiting
13
University of Miami
Miami, Florida, United States, 33136
Actively Recruiting
14
Rush University Medical Center
Chicago, Illinois, United States, 60612
Actively Recruiting
15
University of Chicago
Chicago, Illinois, United States, 60637
Actively Recruiting
16
University of Iowa Health Care
Iowa City, Iowa, United States, 52242
Actively Recruiting
17
Ochsner Clinic Foundation
New Orleans, Louisiana, United States, 70121
Actively Recruiting
18
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Actively Recruiting
19
Wayne State University/Detroit Medical Center Comprehensive Epilepsy Program
Detroit, Michigan, United States, 48201
Actively Recruiting
20
Dartmouth Hitchcock Medical Center/ Department of Neurology
Lebanon, New Hampshire, United States, 03756
Actively Recruiting
21
Hofstra Northwell Comprehensive Epilepsy Center
Great Neck, New York, United States, 11021
Actively Recruiting
22
NYU Langone Comprehensive Epilepsy Center
New York, New York, United States, 10016
Actively Recruiting
23
SUNY Upstate Medical University
Syracuse, New York, United States, 13210
Actively Recruiting
24
Atrium Health
Charlotte, North Carolina, United States, 28204
Actively Recruiting
25
Duke University Hospital
Durham, North Carolina, United States, 27710
Actively Recruiting
26
Atrium Wake Forest Baptist
Winston-Salem, North Carolina, United States, 27157
Actively Recruiting
27
Oregon Health and Science University
Portland, Oregon, United States, 97239
Actively Recruiting
28
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States, 19107
Actively Recruiting
29
UT Southwestern Medical Center
Dallas, Texas, United States, 75390
Actively Recruiting
30
UTHealth Houston
Houston, Texas, United States, 77030
Actively Recruiting
31
University of Utah Health
Salt Lake City, Utah, United States, 84108
Actively Recruiting
32
University of Washington Regional Epilepsy Center
Seattle, Washington, United States, 98104
Actively Recruiting
33
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Actively Recruiting
Research Team
N
Neurona MedInfo
CONTACT
E
Eduardo Dunayevich, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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