Overview
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.
Principal investigator
Eligibility criteria
Key Inclusion Criteria:
- Male or Female, age ≥18 to 65
- 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
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