A Phase I Clinical Trial of UX-GIP001 in the Treatment of Drug-Resistant Unilateral Mesial Temporal Lobe Epilepsy

Sponsor
Shanghai UniXell Biotechnology Co., Ltd
Study ID
NCT07572812
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

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

Interventions

  • UX-GIP001 — DRUG
    Allogeneic human GABAergic interneuron precursors (UX-GIP001) are delivered into the temporal lobe region of the brain.

Study Details

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 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.

Key Dates

Start date
May 20, 2026
Status verified
Apr 2026
Primary completion
Jul 1, 2029
Completion
Jul 1, 2029

Study Design

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

Arms

  • Experimental: UX-GIP001
    Two dose levels will be planned. Each patient only receives one corresponding dose of UX-GIP001.

Primary Outcome Measure

Incidence and severity of Adverse Events (AEs)/Serious Adverse Events (SAEs) [ Time Frame: From baseline to 6 Months post-treatment ]

Central Contacts

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