This clinical trial is designed to test whether a single image-guided intracerebral administration of inhibitory nerve cells, called interneurons (NRTX-1001), into subjects with drug-resistant unilateral mesial temporal lobe epilepsy (MTLE), with or without mesial temporal sclerosis (MTS), is safe (frequency of adverse events) and effective (seizure frequency). NRTX-1001 comprises human interneurons that secrete a neurotransmitter, gamma-aminobutyric acid (GABA).
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
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
History of status epilepticus in the 3 years prior to screening.
Neurona Therapeutics
Lead sponsor
California Institute for Regenerative Medicine (CIRM)
Collaborator