General Information |
| Summary |
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). |
| Description |
Subjects will undergo a single CT or MRI-guided intracerebral administration of human interneurons that secrete the inhibitory neurotransmitter, gamma-aminobutyric acid (GABA), into the temporal lobe region of the brain where the seizures are thought to arise. NRTX-1001 is intended to suppress the onset and spread of seizures. Safety, tolerability, and effects on reducing seizure frequency and epilepsy disease symptoms will be assessed at quarterly intervals for 2 years after the administration of NRTX-1001. After the two-year period, subjects will be followed with quarterly phone calls and annual visits in years 3 through 5, and then annual visits in years 6 through 15. Subjects will be placed on an immunosuppressant medication regimen for a duration of one year to partially suppress the subjects' immune system to promote the intended long-term persistence of NRTX-1001. This immunosuppressant medication is intended to be discontinued after the first year; however, the NRTX-1001 cells are intended to persist long-term. |
| Clinical trials phase |
Phases 1/2 |
| Start date (estimated) |
2022-06-16 |
| End date (estimated) |
2042-02-28 |
| Clinical feature |
| Label |
epilepsy |
| Link |
http://purl.obolibrary.org/obo/DOID_1826 |
| Description |
A brain disease that is characterized by the occurrance of at least two unprovoked seizures resulting from a persistent epileptogenic abnormality of the brain that is able to spontaneously generate paroxysmal activity and typically manifested by sudden brief episodes of altered or diminished consciousness, involuntary movements, or convulsions. |
|
Administrative Information |
| NCT number |
NCT05135091 |
| ICTRP weblink |
https://trialsearch.who.int/Trial2.aspx?TrialID=NCT05135091 |
| Other study identifiers |
|
| Source weblink |
https://www.clinicaltrials.gov/ct2/show/study/NCT05135091 |
| Regulatory body approval |
| Name |
Food and Drug Administration (FDA) |
| Country |
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|
| Sponsors |
Neurona Therapeutics
|
| Collaborators |
|
Cells |
| Which differentiated cell type is used |
| Label |
interneuron |
| Link |
http://purl.obolibrary.org/obo/CL_0000099 |
| Description |
Most generally any neuron which is not motor or sensory. Interneurons may also refer to neurons whose axons remain within a particular brain region as contrasted with projection neurons which have axons projecting to other brain regions. |
|
Recruitment |
| Recruitment Status |
Recruiting |
| Estimated number of participants |
58 |
