Open Actively Recruiting
FIH Study of NRTX-1001 Neural Cell Therapy in Drug-Resistant Unilateral Mesial Temporal Lobe Epilepsy
This clinical trial is designed to test whether a single stereotactic intracerebral administration of inhibitory nerve cells into subjects with drug-resistant mesial temporal lobe epilepsy is safe (frequency of adverse events) and effective (seizure frequency).
Key Inclusion Criteria:
- Male or Female, age ≥18 to 55
- Focal seizures, clinically defined as TLE
- Has failed to achieve seizure control despite adequate trials of at least 2 ASDs at appropriate doses
- Currently on stable doses (at least 1 month) of approved ASDs
- Single seizure focus confirmed as within one temporal lobe
- 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.
- Seizure frequency averages ≥2 per 28-day period over the 6 months prior to screening.
Key Exclusion Criteria:
- Epilepsy due to other and/or progressive neurologic disease
- Significant other medical condition which would impair safe participation
- Primary or secondary immunodeficiency
- Suicide attempt in the past year
- Severe psychiatric disorders
- Chronic indwelling intracranial device
- MRI indicating potential malignant lesion
- Pregnancy, or currently breastfeeding
Join this Trial
Contact our clinical trial navigators for opportunities that may be suitable for you
- UCLA Westwood
For detailed technical eligibility, visit ClinicalTrials.gov.