FIH Study of NRTX-1001 Neural Cell Therapy in Drug-Resistant Unilateral Mesial Temporal Lobe Epilepsy
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- STATUS
- Recruiting
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- End date
- May 4, 2026
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- participants needed
- 40
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- sponsor
- Neurona Therapeutics
Summary
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).
Description
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.
Details
| Condition | Mesial Temporal Lobe Epilepsy With Hippocampal Sclerosis |
|---|---|
| Treatment | Sham comparator, NRTX-1001 |
| Clinical Study Identifier | NCT05135091 |
| Sponsor | Neurona Therapeutics |
| Last Modified on | 4 April 2023 |
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