Exploratory Study of UX-GIP001 Cell Therapy in Adult Patients With Drug-Resistant Unilateral Mesi… (NCT07244328) | Clinical Trial Compass
RecruitingEarly Phase 1
Exploratory Study of UX-GIP001 Cell Therapy in Adult Patients With Drug-Resistant Unilateral Mesial Temporal Lobe Epilepsy (MTLE)
China6 participantsStarted 2025-11-10
Plain-language 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.
Who can participate
Age range18 Years – 75 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
✓. 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.
What they're measuring
1
Incidence and severity of Adverse Events (AEs)/Serious Adverse Events (SAEs)
Timeframe: From baseline to 2 years post surgery
Trial details
NCT IDNCT07244328
SponsorSecond Affiliated Hospital, School of Medicine, Zhejiang University