Study of NRTX-1001 Neural Cell Therapy in Drug-Resistant Unilateral Mesial Temporal Lobe Epilepsy (EPIC (EPIlepsy Cell Therapy))

Prior treatment

• History of status epilepticus in the 3 years prior to screening.
• Prior lobectomy or LITT procedure

Other illness

• Epilepsy due to other medical conditions and/or progressive neurologic disease
• Evidence of seizure focus outside of the hippocampus or evidence of seizures of non- focal origin.
• Significant other medical conditions which would impair safe participation
• Severe psychiatric disorders
• MRI indicating potential malignant lesion

Other

• Primary or secondary immunodeficiency
• Suicide attempts in the past year 3 years
• Pregnancy, or currently breastfeeding.

• Male or Female, age ≥18 to ≤75
• Focal seizures, clinically defined as unilateral MTLE
• 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 prior to Screening) of approved ASDs
• Single seizure focus confirmed within one hippocampus
• Seizure frequency averages ≥4 per 28-day period, including at least 2 clinical focal seizures per 28-day period with objective manifestations or more severe types, over the 6 months prior to the Screening Visit. (Phase 1/2 only)
• Disabling seizure frequency of ≥2 per 28-day period averaged over 3 months prior to the Screening visit and over a prospective 10-week baseline period prior to Randomization (Phase 3 Only)