drugset / Trial / NCT07244328
Exploratory Study of UX-GIP001 Cell Therapy in Adult Patients With Drug-Resistant Unilateral Mesial Temporal Lobe Epilepsy (MTLE)
Phase 0
Recruiting
6 enrolled
Second Affiliated Hospital, School of Medicine, Zhejiang University
Shanghai UniXell Biotechnology Co., Ltd · collab
NaSingle-groupOpen-labelTreatment
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.
Timeline
- Start
- 2025-11-10
- Primary completion
- 2028-11-30
- Completion
- 2028-11-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | UX-GIP001 | Cell therapy | — | Other |