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

  • End date
    May 4, 2026
  • participants needed
  • sponsor
    Neurona Therapeutics
Updated on 4 April 2023


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).


Subjects will undergo a single stereotactic intracerebral administration of neural cells, called interneurons, that secrete the inhibitory neurotransmitter gamma-aminobutyric acid (GABA).

Subjects will then take medicines to partially suppress their immune system (aimed to prevent the body from rejecting the cells) for 1 year. Safety, tolerability, evidence of neural cell viability and local inflammation (using MRI scans of the brain), and effects on epilepsy disease symptoms will be assessed for 2 years post-transplant. Subjects will be followed for an additional 13 years with quarterly phone contact and annual visits.

Condition Mesial Temporal Lobe Epilepsy With Hippocampal Sclerosis
Treatment Sham comparator, NRTX-1001
Clinical Study IdentifierNCT05135091
SponsorNeurona Therapeutics
Last Modified on4 April 2023


Yes No Not Sure

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

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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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