Exploratory Study of UX-GIP001 Cell Therapy in Adult Patients With Drug-Resistant Unilateral Mesial Temporal Lobe Epilepsy (MTLE)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: UX-GIP001.
- Who it may be relevant to
- Registry conditions: Epilepsy, MTLE. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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
Overview
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.
Detailed description
Participants will receive UX-GIP001 via stereotactic neurosurgery, preceded by and followed with immunosuppressive therapy. The study includes a baseline period for eligibility confirmation and a 24-month follow-up phase involving regular safety assessments, neuroimaging , seizure diary logging, and evaluations of quality of life, cognition, and mood. This pioneering regenerative approach seeks to provide a new treatment strategy for drug-resistant MTLE by addressing the underlying pathophysiology.
Interventions
- Biological UX-GIP001
Allogeneic human GABAergic interneuron precursors (UX-GIP001) are delivered into the temporal lobe region of the brain.
Primary outcome measures
- Incidence and severity of Adverse Events (AEs)/Serious Adverse Events (SAEs) [Time frame: From baseline to 2 years post surgery]
Secondary outcome measures (3)
- Change from baseline in total and subtype seizure frequency [Time frame: From baseline to 2 years post surgery]
- Responder rates (≥50% and ≥75% reduction) in total and subtype seizure frequency [Time frame: From baseline to 2 years post surgery]
- Seizure free rate [Time frame: From baseline to 2 years post surgery]
Eligibility criteria
Inclusion criteria
- 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 criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Second Affiliated Hospital, School of Medicine, Zhejiang University — Hangzhou
Identifiers
NCT: NCT07244328 · 2025-0876