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.
Age 18-75 years (inclusive), male or female;
Diagnosis of focal epilepsy according to the International League Against Epilepsy (ILAE) 2025 epilepsy classification, with disease duration ≥2 years;
Clinical presentation consistent with unilateral mesial temporal lobe epilepsy (MTLE);
Meeting the diagnostic criteria for drug-resistant epilepsy;
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.
Shanghai UniXell Biotechnology Co., Ltd
Lead sponsor
West China Hospital
Collaborator
Beijing Tiantan Hospital
Collaborator
The First Affiliated Hospital of Zhengzhou University
Collaborator