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Search / Trial NCT05135091

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

Launched by NEURONA THERAPEUTICS · Nov 16, 2021

Trial Information

Current as of July 09, 2025

Recruiting

Keywords

Epilepsy Mtle Seizure

ClinConnect Summary

This clinical trial is testing a new treatment called NRTX-1001, which involves injecting special nerve cells into the brain to help people with a type of epilepsy known as mesial temporal lobe epilepsy. This condition is often resistant to standard medications, meaning that patients continue to have seizures even after trying several different treatments. The main goals of the study are to see if this new therapy is safe and if it can help reduce the number of seizures in patients.

To participate in this trial, you must be between 18 and 65 years old and have been diagnosed with focal seizures, specifically temporal lobe epilepsy, that have not responded to at least two different medications. You should also be taking a stable dose of your current epilepsy medications for at least a month. The study is looking for individuals who have been experiencing an average of two or more seizures every 28 days over the past six months. If you decide to join, you will receive the nerve cell treatment, and the researchers will closely monitor your health and seizure activity to determine how well it works. This trial is currently looking for participants, so if you or someone you know fits the criteria, it may be worth discussing with a healthcare provider.

Gender

ALL

Eligibility criteria

  • Key Inclusion 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).
  • Key Exclusion Criteria:
  • 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.

About Neurona Therapeutics

Neurona Therapeutics is a clinical-stage biopharmaceutical company dedicated to developing innovative therapies for neurological disorders. Focused on harnessing the power of engineered cells, Neurona aims to create targeted treatments that address the underlying causes of conditions such as epilepsy and other central nervous system disorders. With a team of experts in neuroscience and cell therapy, Neurona is committed to advancing its proprietary platform to improve patient outcomes and enhance quality of life for individuals affected by debilitating neurological conditions.

Locations

Palo Alto, California, United States

Milwaukee, Wisconsin, United States

Chicago, Illinois, United States

Boston, Massachusetts, United States

Little Rock, Arkansas, United States

New Orleans, Louisiana, United States

Chicago, Illinois, United States

Sacramento, California, United States

Philadelphia, Pennsylvania, United States

Miami, Florida, United States

Portland, Oregon, United States

Syracuse, New York, United States

San Francisco, California, United States

Los Angeles, California, United States

Iowa City, Iowa, United States

Omaha, Nebraska, United States

San Diego, California, United States

Orange, California, United States

Phoenix, Arizona, United States

Durham, North Carolina, United States

Durham, North Carolina, United States

Aurora, Colorado, United States

Charlotte, North Carolina, United States

Salt Lake City, Utah, United States

Los Angeles, California, United States

New York, New York, United States

Houston, Texas, United States

Phoenix, Arizona, United States

Tucson, Arizona, United States

Detroit, Michigan, United States

Winston Salem, North Carolina, United States

Patients applied

0 patients applied

Trial Officials

John Hixson, MD

Study Director

Neurona Therapeutics

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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