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Brain cell transplant shows promise for Tough-to-Treat epilepsy

NCT ID NCT05135091

Disease control Sponsor: Neurona Therapeutics Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests a one-time injection of lab-grown nerve cells (NRTX-1001) into the brain for people with a specific type of epilepsy that doesn't respond to medication. The cells are designed to release a calming chemical called GABA to quiet overactive brain signals. Researchers will compare seizure reduction in 88 participants who receive either the cell therapy or a sham procedure.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
NRTX-1001 (lab-grown nerve cells that release GABA, a calming chemical in the brain)
What this could lead to
If it works, this could offer a new way to control seizures in people with drug-resistant epilepsy, potentially reducing or eliminating the need for daily medication.
What could go wrong
This is still experimental and in early Phase 3 testing. It may not work for everyone, and there are risks from the brain injection procedure. Long-term effects are unknown.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 88 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2022

Expected to finish

Sep 2043

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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 prior to Screening) 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. (Phase 1/2 only) 7. Disabling seizure frequency of ≥2 per 28-day period averaged over 3 months prior to the Screening visit and over a prospective 10-week baseline period prior to Randomization (Phase 3 Only) Key Exclusion Criteria: 1. Epilepsy due to other medical conditions 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 3 years prior to screening. 5. Primary or secondary immunodeficiency 6. Suicide attempts in the past year 3 years 7. Severe psychiatric disorders 8. Prior lobectomy or LITT procedure 9. MRI indicating potential malignant lesion 10. Pregnancy, or currently breastfeeding.

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Conditions

The condition(s) this trial relates to.

epilepsy mesial temporal lobe epilepsy with hippocampal sclerosis temporal lobe epilepsy visual epilepsy

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Mesial temporal lobe epilepsy

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    35 sites. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Atrium Health

    RECRUITING

    Charlotte, North Carolina, 28204, United States

  • Atrium Wake Forest Baptist

    RECRUITING

    Winston-Salem, North Carolina, 27157, United States

  • Banner-University of Arizona Medical Center Tucson Comprehensive Epilepsy Program

    RECRUITING

    Tucson, Arizona, 85724-5023, United States

  • Beth Israel Deaconess Medical Center

    RECRUITING

    Boston, Massachusetts, 02215, United States

  • Dartmouth Hitchcock Medical Center/ Department of Neurology

    RECRUITING

    Lebanon, New Hampshire, 03756, United States

  • Duke University Hospital

    RECRUITING

    Durham, North Carolina, 27710, United States

  • George Washington University

    RECRUITING

    Washington D.C., District of Columbia, 20037, United States

  • Hofstra Northwell Comprehensive Epilepsy Center

    RECRUITING

    Great Neck, New York, 11021, United States

  • Mayo Clinic Arizona Epilepsy Center

    RECRUITING

    Phoenix, Arizona, 85054, United States

  • Medical College of Wisconsin

    RECRUITING

    Milwaukee, Wisconsin, 53226, United States

  • NYU Langone Comprehensive Epilepsy Center

    RECRUITING

    New York, New York, 10016, United States

  • Ochsner Clinic Foundation

    RECRUITING

    New Orleans, Louisiana, 70121, United States

  • Oregon Health and Science University

    RECRUITING

    Portland, Oregon, 97239, United States

  • Rush University Medical Center

    RECRUITING

    Chicago, Illinois, 60612, United States

  • SUNY Upstate Medical University

    RECRUITING

    Syracuse, New York, 13210, United States

  • Stanford University

    RECRUITING

    Palo Alto, California, 94304, United States

  • Thomas Jefferson University Hospital

    RECRUITING

    Philadelphia, Pennsylvania, 19107, United States

  • UC Irvine Medical Center

    RECRUITING

    Orange, California, 92868, United States

  • UT Southwestern Medical Center

    RECRUITING

    Dallas, Texas, 75390, United States

  • UTHealth Houston

    RECRUITING

    Houston, Texas, 77030, United States

  • University of Alabama

    RECRUITING

    Birmingham, Alabama, 35294, United States

  • University of Arkansas for Medical Sciences

    RECRUITING

    Little Rock, Arkansas, 72205, United States

  • University of California Davis

    RECRUITING

    Sacramento, California, 95817, United States

  • University of California Los Angeles

    RECRUITING

    Los Angeles, California, 90095, United States

  • University of California San Diego

    RECRUITING

    San Diego, California, 92037, United States

  • University of California San Francisco

    RECRUITING

    San Francisco, California, 94143, United States

  • University of Chicago

    RECRUITING

    Chicago, Illinois, 60637, United States

  • University of Colorado Anschutz Medical Campus

    RECRUITING

    Aurora, Colorado, 80045, United States

  • University of Iowa Health Care

    RECRUITING

    Iowa City, Iowa, 52242, United States

  • University of Miami

    RECRUITING

    Miami, Florida, 33136, United States

  • University of Southern California Keck Hospital

    RECRUITING

    Los Angeles, California, 90033, United States

  • University of Utah Health

    RECRUITING

    Salt Lake City, Utah, 84108, United States

  • University of Washington Regional Epilepsy Center

    RECRUITING

    Seattle, Washington, 98104, United States

    Contact Email: •••••@•••••

  • Washington University at St. Louis

    RECRUITING

    St Louis, Missouri, 63100, United States

  • Wayne State University/Detroit Medical Center Comprehensive Epilepsy Program

    RECRUITING

    Detroit, Michigan, 48201, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.