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.
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
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.
Single group
NRTX-1001
Biological/VaccineBiological: 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.
Incidence of Serious Adverse Events at end of month 12
Change in frequency of clinical seizures
Seizure frequency change during months 7-12, compared to frequency of clinical seizures in the 6-month baseline period.
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