General Information |
| 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. |
| Clinical trials phase |
Phases 1/2 |
| Start date (estimated) |
2022-06-16 |
| End date (estimated) |
2026-05-31 |
| 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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|
| Public contact |
| Email |
sheri.madrid@neuronatx.com |
| Public email |
sheri.madrid@neuronatx.com |
| First name |
Sheri |
| Last name |
Madrid |
| Phone |
+1 949-500-0027 |
| Country |
|
|
| 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 |
40 |
