← Back to Search

Neural Cell Therapy

NRTX-1001 Neural Cell Therapy for Epilepsy

Phase 1 & 2
Recruiting
Research Sponsored by Neurona Therapeutics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Currently on stable doses (at least 1 month) of approved ASDs
Seizure frequency averages ≥2 per 28-day period over the 6 months prior to screening
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights

Study Summary

This trial is testing whether a single administration of inhibitory nerve cells into the brain of subjects with drug-resistant epilepsy is safe and effective.

Who is the study for?
This trial is for adults aged 18 to 65 with drug-resistant mesial temporal lobe epilepsy. Participants must have a history of focal seizures, be on stable epilepsy medication doses, and have confirmed seizure focus in one temporal lobe. They should not have attempted suicide in the past year, severe psychiatric disorders, pregnancy or breastfeeding status, progressive neurological diseases other than epilepsy, significant medical conditions that impair participation, immunodeficiency or chronic intracranial devices.Check my eligibility
What is being tested?
The study tests NRTX-1001 neural cell therapy's safety and effectiveness against placebo (sham comparator) in reducing seizure frequency. It involves a single stereotactic injection of inhibitory nerve cells directly into the brain of subjects with unilateral mesial temporal lobe epilepsy who haven't responded to at least two anti-seizure drugs.See study design
What are the potential side effects?
Potential side effects may include adverse reactions related to brain injections such as headache, bleeding or infection at the injection site; immune response issues due to foreign cells; and any unforeseen complications from altering brain cell activity.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have been on a stable dose of my seizure medication for at least a month.
Select...
I have had an average of 2 or more seizures every month for the last 6 months.
Select...
I still have seizures despite trying at least 2 different seizure medications.
Select...
I have focal seizures known as temporal lobe epilepsy.
Select...
I am between 18 and 65 years old.
Select...
My seizures originate from a part of my brain that doesn't affect speech, or if they do, my memory test scores are low.
Select...
My seizures are confirmed to originate from one side of my brain.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Frequency of serious or severe AEs
Secondary outcome measures
Change in seizure frequency
Responder rate

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: NRTX-1001 (Stage 2)Experimental Treatment1 Intervention
Up to 20 subjects.
Group II: NRTX-1001 (Stage 1)Experimental Treatment1 Intervention
Up to 10 subjects.
Group III: Sham Comparator (Stage 2)Placebo Group1 Intervention
Up to 10 subjects.

Find a Location

Who is running the clinical trial?

Neurona TherapeuticsLead Sponsor
California Institute for Regenerative Medicine (CIRM)OTHER
63 Previous Clinical Trials
3,114 Total Patients Enrolled
David Blum, MDStudy DirectorNeurona Therapeutics
3 Previous Clinical Trials
402 Total Patients Enrolled

Media Library

NRTX-1001 (Neural Cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05135091 — Phase 1 & 2
Mesial Temporal Lobe Epilepsy Research Study Groups: NRTX-1001 (Stage 1), NRTX-1001 (Stage 2), Sham Comparator (Stage 2)
Mesial Temporal Lobe Epilepsy Clinical Trial 2023: NRTX-1001 Highlights & Side Effects. Trial Name: NCT05135091 — Phase 1 & 2
NRTX-1001 (Neural Cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05135091 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this medical trial open to participants of all ages, including those over 35?

"According to the trial conditions, only individuals aged 18-55 will be considered for inclusion."

Answered by AI

What are the criteria for entering this clinical trial?

"To be considered for the trial, potential participants must show evidence of aura and their age should lie between 18 to 55. Up to 40 people will be selected in total."

Answered by AI

How many participants are allotted to this clinical experiment?

"To satisfy the requirements of this trial, 40 qualified participants are required. Those who wish to partake can do so at either Stanford University in Palo Alto or Oregon Health and Science University in Portland."

Answered by AI

Are there multiple sites in Canada conducting this experiment?

"Currently, 8 clinical trial sites are hosting this research. Locations include Palo Alto, Portland and Chicago as well as 5 additional cities. If a participant is accepted into the study, it is advised to choose the closest site in order to ease travel requirements."

Answered by AI

Are there any vacant slots available in this research trial?

"Affirmative, the information presented on clinicaltrials.gov attests that this investigation is still in search of participants. It was initially published on June 16th 2022 and has been modified most recently on September 26th 2022. 40 volunteers are required to be enrolled from 8 different venues."

Answered by AI
~15 spots leftby May 2025