FIH Study of NRTX-1001 Neural Cell Therapy in Drug-Resistant Unilateral Mesial Temporal Lobe Epilepsy

Open to people ages 18-65

1. Male or Female, age ≥18 to 65
2. Focal seizures, clinically defined as TLE
3. Has failed to achieve seizure control despite adequate trials of at least 2 ASDs at appropriate doses
4. Currently on stable doses (at least 1 month) of approved ASDs
5. Single seizure focus confirmed as within one temporal lobe
6. For subjects entering Stage 1, the seizure focus is either a) in the non-dominant hemisphere, or b) in the dominant hemisphere and the subject has a Rey Auditory Verbal Learning Test (RAVLT) assessed within one year of screening, or at the screening visit, that is at least 1.5 standard deviations below the population mean.
7. Seizure frequency averages ≥2 per 28-day period over the 6 months prior to screening.

1. Epilepsy due to other and/or progressive neurologic disease
2. Significant other medical condition which would impair safe participation
3. Primary or secondary immunodeficiency
4. Suicide attempt in the past year
5. Severe psychiatric disorders
6. Chronic indwelling intracranial device
7. MRI indicating potential malignant lesion
8. Pregnancy, or currently breastfeeding