Tests NRTX-1001 cell therapy for hard-to-treat temporal lobe epilepsy
Tests NRTX-1001 nerve cells placed in both temporal lobes of adults with drug-resistant epilepsy.
Plain-language title generated from the registry record
Registry title: A Phase 1/2 Study of NRTX-1001 Neuronal Cell Therapy in Drug-Resistant Bilateral Mesial Temporal Lobe Epilepsy (MTLE)
Key facts
- Where
- Aurora, Charlotte, Charlottesville, Chicago, Durham, Houston, Iowa City, Little Rock, Los Angeles, Milwaukee, Orange, Palo Alto, Portland, San Diego, San Francisco, Syracuse, and Winston-Salem, United StatesSee the 17 sites
- Phase
- Phase 1/2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Source: NCT06422923, who can take part
Where in United States
- University of Colorado Anschutz Medical CampusAurora, United StatesTaking people
- Atrium HealthCharlotte, United StatesTaking people
- UVA Health University Medical CenterCharlottesville, United StatesTaking people
- University of ChicagoChicago, United StatesTaking people
- Duke University HospitalDurham, United StatesTaking people
- UTHealth HoustonHouston, United StatesTaking people
- University of Iowa Health CareIowa City, United StatesTaking people
- University of Arkansas for Medical SciencesLittle Rock, United StatesTaking people
- University of Southern California Keck HospitalLos Angeles, United StatesTaking people
- Medical College of WisconsinMilwaukee, United StatesTaking people
- UC Irvine Medical CenterOrange, United StatesTaking people
- Stanford UniversityPalo Alto, United StatesTaking people
- Oregon Health and Science UniversityPortland, United StatesTaking people
- University of California San DiegoSan Diego, United StatesTaking people
- University of California San FranciscoSan Francisco, United StatesNo longer taking part
- SUNY Upstate Medical UniversitySyracuse, United StatesTaking people
- Wake Forest Baptist Medical CenterWinston-Salem, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Neurona Therapeutics
- Trial code
- NCT06422923
- Record updated
- 7 January 2026
- Original description
This is a multicenter, single arm, open label clinical trial that is designed to test the safety and preliminary efficacy of single administration inhibitory nerve cells called interneurons (NRTX-1001), into both temporal lobes of subjects with drug-resistant bilateral mesial temporal lobe epilepsy.Read full original descriptionShow less
A Phase 1/2 Study of NRTX-1001 Neuronal Cell Therapy in Drug-Resistant Bilateral Temporal Lobe Epilepsy (MTLE)
This is a multicenter, single arm, open label clinical trial that is designed to test the safety and preliminary efficacy of single administration inhibitory nerve cells called interneurons (NRTX-1001), into both temporal lobes of subjects with drug-resistant bilateral mesial temporal lobe epilepsy.
Inclusion: Male or female, age 18-75 years; Subjects of childbearing potential will use highly effective contraception; 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); Either; 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; 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; 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; 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; Subject has previously had adequate (in opinion of investigator) therapeutic trials of at least two Anti-Seizure Medicines (ASMs); 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; Subject can converse and read in English or Spanish. Able to participate in required study procedures and provide signed informed consent.
Exclusion: 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; Epilepsy due to other and/or progressive neurologic disease; Evidence of seizure focus outside hippocampus (either by seizure semiology or EEG findings); 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; Seizures of non-focal origin; Psychogenic Non-Epileptic Seizures (PNES) within the past 3 years; Severe psychiatric disorders; Significant other medical conditions which would impair safe participation; Primary or secondary immunodeficiency; Pregnancy, or currently breastfeeding; Suicide attempts in past year.