RecruitingPhase 1interventionalRules rewrite

Phase 1: testing UX-GIP001 for Epilepsy

This is a phase I study (Protocol: UX-GIP001-102) investigating UX-GIP001 Injection, a novel cell therapy product consisting of human GABAergic interneuron progenitor cells (GIP), for treating adult patients with drug-resistant unilateral medial temporal lobe epilepsy (MTLE). The primary objective is to assess the safety, tolerability, and preliminary how well it works of UX-GIP001.

Official registry: https://clinicaltrials.gov/study/NCT07572812 · Shanghai UniXell Biotechnology Co., Ltd · enrollment listed as 12

What this phase means

Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are UX-GIP001. The registry lists allocation as na. This is a phase I study (Protocol: UX-GIP001-102) investigating UX-GIP001 Injection, a novel cell therapy product consisting of human GABAergic interneuron progenitor cells (GIP), for treating adult patients with drug-resistant unilateral medial temporal lobe epilepsy (MTLE).

They plan to enroll about 12 people at 3 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

A Phase I Clinical Trial to Evaluate the Safety, Tolerability, and Preliminary Efficacy of UX-GIP001 (Human GABAergic Interneuron Progenitor Cells Injection) in the Treatment of Drug-Resistant Unilateral Mesial Temporal Lobe Epilepsy

Interventions: UX-GIP001

Primary outcome (registry wording): Incidence and severity of Adverse Events (AEs)/Serious Adverse Events (SAEs)

Who it is for (from inclusion criteria)

Ages 18 Years to 75 Years
Age 18-75 years (inclusive), male or female;
Diagnosis of focal epilepsy according to the International League Against Epilepsy (ILAE) 2025 epilepsy classification, with disease duration ≥2 years;
Clinical presentation consistent with unilateral mesial temporal lobe epilepsy (MTLE);
Meeting the diagnostic criteria for drug-resistant epilepsy;
Average focal seizure frequency ≥4 per 28 days within the 3 months prior to screening;
On a stable dose of anti-seizure medications for ≥1 month prior to enrollment;
Patient has good compliance, with a patient diary completion rate ≥80% prior to enrollment

Who the registry excludes

Epilepsy caused by other/or progressive neurological diseases , or patients - experiencing only focal aware seizures without observable manifestations
History of epilepsy surgery
History of status epilepticus within 12 months prior to screening
Presence of long-term implants in the skull or intracranial space
Severe systemic disease or dysfunction
Primary or secondary immunodeficiency
History of clear suicidal intent, plan, or behavior within one year prior to screening

Public study contact (from the registry)

Xianwei Zhi

+86-21-60197620

xianweizhi@unixell.com

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

3 listed

Beijing Tiantan Hospital, Capital Medical University — Beijing, Beijing Municipality, China (recruiting)
The First Affiliated Hospital of Zhengzhou University — Zhengzhou, Henan, China (not_yet_recruiting)
West China School of Medicine and West China Hospital, Sichuan University — Chengdu, Sichuan, China (recruiting)

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FAQ about this NCT record

Is NCT07572812 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT07572812?

Phase 1. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT07572812?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary