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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
12
Allogeneic human GABAergic interneuron precursors (UX-GIP001) are delivered into the temporal lobe region of the brain.
Beijing Tiantan Hospital, Capital Medical University
Beijing, Beijing Municipality, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
West China School of Medicine and West China Hospital, Sichuan University
Chengdu, Sichuan, China
Incidence and severity of Adverse Events (AEs)/Serious Adverse Events (SAEs)
Time frame: From baseline to 6 Months post-treatment
Change from baseline in total and subtype seizure frequency
Time frame: From baseline to 2 years post-treatment
Responder rates (≥50% and ≥75% reduction) in total and subtype seizure frequency
Time frame: From baseline to 2 years post-treatment
Seizure free rate
Time frame: From baseline to 2 years post-treatment
Incidence and severity of AEs/SAEs related to surgery, transplanted cells, and/or immunosuppressive therapy
Time frame: From baseline to 2 years post-treatment
Incidence and severity of all AEs/SAEs
Time frame: From baseline to 2 years post-treatment
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