A Phase 1/2 Study of NRTX-1001 Neuronal Cell Therapy in Drug-Resistant Bilateral Mesial Temporal Lobe Epilepsy (MTLE)

Part of paid clinical trials in Little Rock, Arkansas.

Sponsor
Neurona Therapeutics
Study ID
NCT06422923
Phase
PHASE1/PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Epilepsy, Temporal Lobe

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • NRTX-1001 — BIOLOGICAL
    Biological: NRTX-1001 is an inhibitory neural cell therapy investigational product. It is derived from a human stem cell line that has been converted into high-purity inhibitory interneurons that produce GABA. NRTX-1001 is intended to persist long-term and not require repeated administration.

Study Details

This is a multicenter, single arm, open label clinical trial that is designed to test the safety and preliminary efficacy of single administration inhibitory nerve cells called interneurons (NRTX-1001), into both temporal lobes of subjects with drug-resistant bilateral mesial temporal lobe epilepsy.

Key Dates

Start date
Nov 14, 2024
Status verified
Jan 2026
Primary completion
Jun 15, 2027
Completion
Jun 15, 2042

Study Design

Enrollment
10 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment Arm
    This is an open-label study of the bilateral intrahippocampal administration of NRTX-1001 in a single dose cohort of up to 10 subjects with drug-resistant bilateral MTLE.

Primary Outcome Measure

Incidence of Serious Adverse Events at end of month 12 [ Time Frame: 12 months after treatment ]

Central Contacts

Locations (17)

FacilityCityStateZIPSite coordinators
University of Arkansas for Medical SciencesLittle RockArkansas72205
Shellah Rogers, Nurse
[email protected]
501-398-8622
Sisira Yadala, MD (PRINCIPAL_INVESTIGATOR)
University of Southern California Keck HospitalLos AngelesCalifornia90033
Zoe B Durkin, SC
[email protected]
323-422-6625
Charles Y Liu, MD, PhD (PRINCIPAL_INVESTIGATOR)
UC Irvine Medical CenterOrangeCalifornia92868
UCI Alpha Clinic
949-824-3990
Mona Sazgar, MD (PRINCIPAL_INVESTIGATOR)
Stanford UniversityPalo AltoCalifornia94304
Jordan Seliger, CRC, MA
[email protected]
650-460-9260
Kevin Graber, MD (PRINCIPAL_INVESTIGATOR)
University of California San DiegoSan DiegoCalifornia92037
Mateo Santizo, CRC
[email protected]
(858)583-0929
Jerry J Shih, MD (PRINCIPAL_INVESTIGATOR)
University of California San FranciscoSan FranciscoCalifornia94143-
University of Colorado Anschutz Medical CampusAuroraColorado80045
Pamela D Gerecht, Ph.D. SC
[email protected]
303-724-4134
Steven Ojemann, MD (PRINCIPAL_INVESTIGATOR)
University of ChicagoChicagoIllinois60637
Agnieszka Stadnik, MS
[email protected]
773-702-8996
Peter Warnke, MD (PRINCIPAL_INVESTIGATOR)
University of Iowa Health CareIowa CityIowa52242
Loraine Brenner, MSN
[email protected]
319-356-4361
Mark Granner, MD (PRINCIPAL_INVESTIGATOR)
SUNY Upstate Medical UniversitySyracuseNew York13210
Lena F Deb, BA
[email protected]
315-464-9756
Shahram Izadyar, MD (PRINCIPAL_INVESTIGATOR)
Atrium HealthCharlotteNorth Carolina28204
Dianelis Diaz, RN, BSN, CRC
[email protected]
704-446-1900
Rajdeep Singh, MD (PRINCIPAL_INVESTIGATOR)
Duke University HospitalDurhamNorth Carolina27710
Hazani Benitez-Rosas
[email protected]
919-681-4974
Derek Southwell, MD, PhD (PRINCIPAL_INVESTIGATOR)
Wake Forest Baptist Medical CenterWinston-SalemNorth Carolina27157
Carolyn W Hedrick, RMA, CCRP
[email protected]
336-716- 8694
Gautam S Popli, MD, MBA (PRINCIPAL_INVESTIGATOR)
Oregon Health and Science UniversityPortlandOregon97239
Claire Dorfman, BA
[email protected]
971-413-9201
David C Spencer, MD (PRINCIPAL_INVESTIGATOR)
UTHealth HoustonHoustonTexas77030
Eliana M Klier, PhD
[email protected]
713-500-5442
Nitin Tandon, MD (PRINCIPAL_INVESTIGATOR)
UVA Health University Medical CenterCharlottesvilleVirginia22903
Kimberlee E Meegan, BS, CRC III
[email protected]
434-243-2040
Nathan Fountain, MD (PRINCIPAL_INVESTIGATOR)
Medical College of WisconsinMilwaukeeWisconsin53226
Sarah Young, MS
[email protected]
414-955-0989
Sean Lew, MD (PRINCIPAL_INVESTIGATOR)

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