RecruitingEarly Phase 1NCT07244328

Exploratory Study of UX-GIP001 Cell Therapy in Adult Patients With Drug-Resistant Unilateral Mesial Temporal Lobe Epilepsy (MTLE)

An Exploratory Clinical Trial of UX-GIP001 Injection (Human GABAergic Interneuron Progenitor Cells Injection) in Adult Patients With Drug-Resistant Unilateral Mesial Temporal Lobe Epilepsy

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Enrollment

6 participants

Start Date

Nov 10, 2025

Study Type

INTERVENTIONAL

Conditions

Epilepsy MTLE

Summary

This is an exploratory clinical trial (Protocol: UX-GIP001-101) 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 efficacy of UX-GIP001. This is an open-label, single-arm study. All enrolled participants will receive the active investigational cell therapy. Seizure frequency and safety parameters will be evaluated by comparing post-transplant outcomes to pre-transplant baselines.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Inclusion Criteria6

Age 18-75 (inclusive), male or female.
Clinical presentation consistent with unilateral mesial temporal lobe epilepsy (MTLE).
Has failed to achieve seizure control despite treatment with at least two anti-seizure medications (ASMs) at recommended or maximally tolerated doses.
Average focal seizure frequency ≥4 per 28 days during the 3 months prior to screening.
Stable doses of ASMs for ≥1 month prior to enrollment.
Patient is in good general health or has stable comorbid conditions, and has adequate organ function.

Exclusion Criteria10

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.
Severe psychiatric disorders.
History of malignancy within the past 5 years, except for cervical carcinoma in situ, basal cell or squamous cell skin cancer cured for >5 years.
Pregnant or breastfeeding women.