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

Description

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).

Conditions

Mesial Temporal Lobe Epilepsy

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Study Overview

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Study Details

Study overview

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).

A First-In-Human (FIH) Study of Inhibitory Interneurons (NRTX- 1001) in Drug-Resistant Unilateral Mesial Temporal Lobe Epilepsy (MTLE)

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

Condition
Mesial Temporal Lobe Epilepsy
Intervention / Treatment

-

Contacts and Locations

Phoenix

Mayo Clinic Arizona Epilepsy Center, Phoenix, Arizona, United States, 85054

Tucson

Banner-University of Arizona Medical Center Tucson Comprehensive Epilepsy Program, Tucson, Arizona, United States, 85724-5023

Little Rock

University of Arkansas for Medical Sciences, Little Rock, Arkansas, United States, 72205

Los Angeles

University of Southern California Keck Hospital, Los Angeles, California, United States, 90033

Los Angeles

University of California Los Angeles, Los Angeles, California, United States, 90095

Orange

UC Irvine Medical Center, Orange, California, United States, 92868

Palo Alto

Stanford University, Palo Alto, California, United States, 94304

Sacramento

University of California Davis, Sacramento, California, United States, 95817

San Diego

University of California San Diego, San Diego, California, United States, 92037

San Francisco

University of California San Francisco, San Francisco, California, United States, 94143

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. Male or Female, age ≥18 to 75
  • 2. Focal seizures, clinically defined as unilateral MTLE
  • 3. Has failed to achieve seizure control despite adequate trials of at least 2 ASDs at appropriate doses
  • 4. Currently on stable doses (at least 1 month) of approved ASDs
  • 5. Single seizure focus confirmed within one hippocampus
  • 6. Seizure frequency averages ≥4 per 28-day period, including at least 2 clinical focal seizures per 28-day period with objective manifestations or more severe types, over the 6 months prior to the Screening Visit.
  • 7. Considered (by Investigator) to be a candidate for temporal lobectomy (TL) or Laser Interstitial Thermal Therapy (LITT) following evaluation at a qualified epilepsy surgery program (National Association of Epilepsy Centers \[NAEC\] Level 4).
  • 1. Epilepsy due to other and/or progressive neurologic disease
  • 2. Evidence of seizure focus outside of the hippocampus or evidence of seizures of non- focal origin.
  • 3. Significant other medical conditions which would impair safe participation
  • 4. History of status epilepticus in the year prior to screening. A history of cluster seizures is permitted.
  • 5. Primary or secondary immunodeficiency
  • 6. Suicide attempts in the past year
  • 7. Severe psychiatric disorders
  • 8. Prior lobectomy or LITT procedure
  • 9. MRI indicating potential malignant lesion
  • 10. Pregnancy, or currently breastfeeding.

Ages Eligible for Study

18 Years to 75 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Neurona Therapeutics,

John Hixson, MD, STUDY_DIRECTOR, Neurona Therapeutics

Study Record Dates

2042-02