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RecruitingPhase 3

Study of NRTX-1001 Neural Cell Therapy in Drug-Resistant Unilateral Mesial Temporal Lobe Epilepsy (EPIC (EPIlepsy Cell Therapy))

Neurona Therapeutics · with California Institute for Regenerative Medicine (CIRM) · NCT05135091

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Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18–75 · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Phase 3
Target enrollment
88
US sites recruiting
35
Study start
June 16, 2022
Record last updated
June 9, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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).

Being studied: NRTX-1001; NRTX-1001; Sham Comparator

Conditions: Mesial Temporal Lobe Epilepsy

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

Key Inclusion Criteria

  • Male or Female, age ≥18 to ≤75
  • Focal seizures, clinically defined as unilateral MTLE
  • Has failed to achieve seizure control despite adequate trials of at least 2 ASDs at appropriate doses
  • Currently on stable doses (at least 1 month prior to Screening) of approved ASDs
  • Single seizure focus confirmed within one hippocampus
  • 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)
  • 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

  • Epilepsy due to other medical conditions and/or progressive neurologic disease
  • Evidence of seizure focus outside of the hippocampus or evidence of seizures of non- focal origin.
  • Significant other medical conditions which would impair safe participation
  • History of status epilepticus in the 3 years prior to screening.
  • Primary or secondary immunodeficiency
  • Suicide attempts in the past year 3 years
  • Severe psychiatric disorders
  • Prior lobectomy or LITT procedure
  • MRI indicating potential malignant lesion
  • Pregnancy, or currently breastfeeding.

Recruiting US locations

  • University of Alabama

    Birmingham, AL 35294

    Site contact: Jennifer Pilkington, SC · jlpilkington@uabmc.edu

  • Mayo Clinic Arizona Epilepsy Center

    Phoenix, AZ 85054

    Site contact: Kayla N Haeger, BSN, RN · 480-342-5075 · Haeger.Kayla@mayo.edu

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

    Tucson, AZ 85724-5023

    Site contact: Faten Sebaali, BA/MA · (520) 626-3576 · fsebaali@arizona.edu

  • University of Arkansas for Medical Sciences

    Little Rock, AR 72205

    Site contact: Shellah Rogers, Nurse · 501-614-2086 · Scrogers2@uams.edu

  • University of Southern California Keck Hospital

    Los Angeles, CA 90033

    Site contact: Zoe B Durkin, SC · 213-631-8487 · zoe.durkin@med.usc.edu

  • University of California Los Angeles

    Los Angeles, CA 90095

    Site contact: Elizabeth Cruz · 310-825-6930 · ElizabethCruz@mednet.ucla.edu

  • UC Irvine Medical Center

    Orange, CA 92868

    Site contact: UCI Alpha Clinic · 949-824-3990 · alphaclinic@hs.uci.edu

  • Stanford University

    Palo Alto, CA 94304

    Site contact: Jordan Seliger, CRC, MA · 650-460-9260 · jseliger@stanford.edu

  • University of California Davis

    Sacramento, CA 95817

    Site contact: Evan Y Shen, BA · 916-734-3009 · evshen@ucdavis.edu

  • University of California San Diego

    San Diego, CA 92037

    Site contact: Mateo Santizo · 858-583-0929 · msantizo@health.ucsd.edu

  • University of California San Francisco

    San Francisco, CA 94143

    Site contact: Sydnie Beausoleil · 631-428-9688 · Sydnie.Beausoleil@ucsf.edu

  • University of Colorado Anschutz Medical Campus

    Aurora, CO 80045

    Site contact: Trey Jouard, MS · 970-817-4272 · Trey.Jouard@cuanschutz.edu

  • George Washington University

    Washington D.C., DC 20037

    Site contact: Preethy Feit, SC · 202-677-6765 · pfeit@mfa.gwu.edu

  • University of Miami

    Miami, FL 33136

    Site contact: Letitia Fisher · 305-775-8582 · lfisher@miami.edu

  • Rush University Medical Center

    Chicago, IL 60612

    Site contact: Amanda Sremac, BS · 312-942-0539 · Amanda_C_Sremac@rush.edu

  • University of Chicago

    Chicago, IL 60637

    Site contact: Agnieszka Stadnik, MS · 773-702-8996 · astadnik@bsd.uchicago.edu

  • University of Iowa Health Care

    Iowa City, IA 52242

    Site contact: Loraine Brenner, MSN · 319-356-4361 · loraine-brenner@uiowa.edu

  • Ochsner Clinic Foundation

    New Orleans, LA 70121

    Site contact: Neydin Osorio, BS, CRC · 504-703-5577 · neydin.tejeda@ochsner.org

  • Beth Israel Deaconess Medical Center

    Boston, MA 02215

    Site contact: Anna George, MSc · 617-632-7031 · ageorge5@bidmc.harvard.edu

  • Wayne State University/Detroit Medical Center Comprehensive Epilepsy Program

    Detroit, MI 48201

    Site contact: Kelly X Jia, MD · 313-966-9407 · xjia@med.wayne.edu

  • Washington University at St. Louis

    St Louis, MO 63100

    Site contact: Victoria Taylor, SC · 314-362-7871 · v.taylor@wustl.edu

  • Dartmouth Hitchcock Medical Center/ Department of Neurology

    Lebanon, NH 03756

    Site contact: Anastasia Kanishcheva, PM · 603) 650-0260 · anastasia.kanishcheva@hitchcock.org

  • Hofstra Northwell Comprehensive Epilepsy Center

    Great Neck, NY 11021

    Site contact: Isabella Henderson · 212-434-4837 · IHenderson@northwell.edu

  • NYU Langone Comprehensive Epilepsy Center

    New York, NY 10016

    Site contact: Jack C Carter, BS · 646-558-0841 · jack.carter@nyulangone.org

  • SUNY Upstate Medical University

    Syracuse, NY 13210

    Site contact: Lena F Deb, BA · 315-464-9756 · debl@upstate.edu

  • Atrium Health

    Charlotte, NC 28204

    Site contact: Dianelis Diaz, RN, BSN, CRC · 704-446-1349 · dianelis.diaz@atriumhealth.org

  • Duke University Hospital

    Durham, NC 27710

    Site contact: Hazani Benitez-Rosas · 919-681-4974 · Hazani.benitez-rosas@duke.edu

  • Atrium Wake Forest Baptist

    Winston-Salem, NC 27157

    Site contact: Carolyn W Hedrick, RMA, CCRP · 336-716-8694 · cwhedric@wakehealth.edu

  • Oregon Health and Science University

    Portland, OR 97239

    Site contact: Claire Dorfman, BA · 971-413-9201 · dorfman@ohsu.edu

  • Thomas Jefferson University Hospital

    Philadelphia, PA 19107

    Site contact: Latasha Adams, MBS · 215-955-2606 · Latasha.adams2@jefferson.edu

  • UT Southwestern Medical Center

    Dallas, TX 75390

    Site contact: Vamsi Vemireddy, SC · 214-645-8159 · vamsidhara.vemireddy@utsouthwestern.edu

  • UTHealth Houston

    Houston, TX 77030

    Site contact: Eliana M Klier, PhD · 713-500-5442 · Eliana.Klier@uth.tmc.edu

  • University of Utah Health

    Salt Lake City, UT 84108

    Site contact: Laura Beeler, BS · 928-530-7990 · laura.beeler@hsc.utah.edu

  • University of Washington Regional Epilepsy Center

    Seattle, WA 98104

    Site contact: Jennifer Steele, CRC · 206-744-2336 · recresearch@uw.edu

  • Medical College of Wisconsin

    Milwaukee, WI 53226

    Site contact: Sarah Young, MS · 414-955-0989 · scyoung@mcw.edu

Study contacts (from the official record)

  • Neurona MedInfo · 650-580-3825 · neuronamedinfo@neuronatx.com
  • Eduardo Dunayevich, MD · 650-436-3045 · edunayevich@neuronatx.com
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Study of NRTX-1001 Neural Cell Therapy in Drug-Resistant… (NCT05135091) | Bored Studies