Exploratory Study of UX-GIP001 Cell Therapy in Adult Patients With Drug-Resistant Unilateral Mesial Temporal Lobe Epilepsy (MTLE)
Recruiting · NCT07244328 · Interventional (participants receive a specific treatment) · Lead sponsor: Second Affiliated Hospital, Zhejiang University, School of Medicine
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
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.
- Key
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.
Where it is running
1 location listed.
- Second Affiliated Hospital, School of Medicine, Zhejiang University - Hangzhou, Zhejiang, China