A Phase 1/2 Study of NRTX-1001 Neuronal Cell Therapy in Drug-Resistant Bilateral Mesial Temporal Lobe Epilepsy (MTLE)
NCT ID: NCT06422923
Last Updated: 2026-01-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
10 participants
INTERVENTIONAL
2024-11-14
2042-06-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Treatment Arm
This is an open-label study of the bilateral intrahippocampal administration of NRTX-1001 in a single dose cohort of up to 10 subjects with drug-resistant bilateral MTLE.
NRTX-1001
Biological: NRTX-1001 is an inhibitory neural cell therapy investigational product. It is derived from a human stem cell line that has been converted into high-purity inhibitory interneurons that produce GABA. NRTX-1001 is intended to persist long-term and not require repeated administration.
Interventions
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NRTX-1001
Biological: NRTX-1001 is an inhibitory neural cell therapy investigational product. It is derived from a human stem cell line that has been converted into high-purity inhibitory interneurons that produce GABA. NRTX-1001 is intended to persist long-term and not require repeated administration.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Subjects of childbearing potential will use highly effective contraception.
3. Proven history of focal seizures of hippocampal origin with bilateral seizure foci confirmed by scalp or intracranial ictal EEG (including confirmation by recordings from responsive neurostimulation \[RNS\] electrodes when applicable).
4. Either
1. bilateral hippocampal sclerosis on MRI (evidenced by increased FLAIR signal intensity in both hippocampi or by visual assessment showing reduced volume compared to normal) or
2. bilateral temporal hypometabolism on 18-Flourodeoxyglucose Positron Emission Tomography (FDG PET) (assessed by visual assessment, comparing temporal regions to frontal/parietal lobe neocortex). In this case, ictal EEG recordings must also include intracranial confirmation.
or
3. a combination of unilateral instances of the evidence described in a. and b. (e.g., one side can be evidenced by criterion a. and the other side by criterion b.) MRI or PET scans used for assessment must have been acquired within 3 years of screening.
5. Subject has had at least four clinical focal seizures, including at least two clinical focal seizures with objective manifestations, on average, per month for the 6 months prior to screening.
6. Subject has previously had adequate (in opinion of investigator) therapeutic trials of at least two Anti-Seizure Medicines (ASMs).
7. Current ASM regimen, and doses of other drugs known to affect seizure frequency (e.g., antidepressants), have been stable for at least three months prior to enrollment.
8. Subject can converse and read in English or Spanish. Able to participate in required study procedures and provide signed informed consent.
Exclusion Criteria
2. Evidence of seizure focus outside hippocampus (either by seizure semiology or EEG findings).
3. MRI indicating potential malignant lesion (low-grade glioma of any type is excluded) in any location or non-malignant potentially epileptogenic lesion outside the hippocampus. Small (\<2 cm) non invasive meningioma, remote from the affected temporal lobe, is not exclusionary.
4. Seizures of non-focal origin.
5. History of status epilepticus in the year prior to screening, as guided by ILAE criteria (Trinka 2015) in the judgement of the PI. A history of cluster seizures is permitted.
6. Psychogenic Non-Epileptic Seizures (PNES) within the past 3 years.
7. Severe psychiatric disorders.
8. Primary or secondary immunodeficiency.
9. Pregnancy, or currently breastfeeding.
10. Suicide attempts in past year.
11. Significant other medical conditions which would impair safe participation.
18 Years
75 Years
ALL
No
Sponsors
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Neurona Therapeutics
INDUSTRY
Responsible Party
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Principal Investigators
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Eduardo Dunayevich, MD
Role: STUDY_DIRECTOR
Neurona Therapeutics
Locations
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University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States
University of Southern California Keck Hospital
Los Angeles, California, United States
UC Irvine Medical Center
Orange, California, United States
Stanford University
Palo Alto, 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
University of Chicago
Chicago, Illinois, United States
University of Iowa Health Care
Iowa City, Iowa, 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
Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, United States
Oregon Health and Science University
Portland, Oregon, United States
UTHealth Houston
Houston, Texas, United States
UVA Health University Medical Center
Charlottesville, Virginia, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Countries
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Central Contacts
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Facility Contacts
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UCI Alpha Clinic
Role: primary
Related Links
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Related Info
Other Identifiers
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NTE002
Identifier Type: -
Identifier Source: org_study_id
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