NCT07244328RecruitingEarly phase 1
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
Source: ClinicalTrials.gov · Last updated 22 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Early phase 1
- Study type
- Interventional
- Enrollment
- 6 (estimated)
- First submitted
- 17 Nov 2025
- Start date
- 10 Nov 2025
- Primary completion date
- 30 Nov 2028
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
- Diseases
- Epilepsy
- NCT number
- NCT07244328
What you commit to
- Study type: Interventional · Early phase 1
- Planned participants: 6
- From 10 Nov 2025 to the primary completion date, 30 Nov 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- History of status epilepticus within 12 months prior to screening.
- Presence of long-term implants in the skull or intracranial space.
- History of clear suicidal intent, plan, or behavior within one year prior to screening.
Other illness
- Epilepsy caused by other/or progressive neurological diseases , or patients experiencing only focal aware seizures without observable manifestations.
- History of epilepsy surgery.
- Severe systemic disease or dysfunction.
- Severe psychiatric disorders.
Age
- 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.
Other
- Primary or secondary immunodeficiency.
- Pregnant or breastfeeding women.
Who the study is looking for
- 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.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Second Affiliated Hospital, School of Medicine, Zhejiang University Coordinator of this site? Confirm its status | Hangzhou | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.