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

Conditions

• Mesial Temporal Lobe Epilepsy

Eligibility Criteria

Sex

ALL

Age

18 Years - 75 Years

Healthy Volunteers

Not accepted

Interventions

• NRTX-1001 — BIOLOGICAL
  Biological: NRTX-1001 is an experimental neural cell therapy product candidate derived from an allogeneic human embryonic stem cell line. The stem cells were converted into inhibitory nerve cells that produce GABA.
• NRTX-1001 — BIOLOGICAL
  Biological: NRTX-1001 is an experimental neural cell therapy product candidate derived from an allogeneic human embryonic stem cell line. The stem cells were converted into inhibitory nerve cells that produce GABA.
• Sham Comparator — PROCEDURE
  Sham Comparator

Study Details

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).

Key Dates

Start date

Jun 16, 2022

Status verified

Mar 2026

Primary completion

Feb 28, 2029

Completion

Sep 30, 2043

Study Design

Enrollment

88 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: NRTX-1001 (Phase 1/2)
  Up to 28 subjects
• Experimental: NRTX-1001 (Phase 3)
  Approximately 40 subjects
• Sham Comparator: Sham Comparator (Phase 3)
  Approximately 20 subjects

Primary Outcome Measure

Frequency of serious or severe AEs (Phase 1/2) [ Time Frame: 1 year ]

Central Contacts

• Neurona MedInfo
  650-580-3825
  [email protected]
• Eduardo Dunayevich, MD
  650-436-3045
  [email protected]

Locations (35)

Find similar trials in Birmingham, AL

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