drugset / Trial / NCT07572812
A Phase I Clinical Trial of UX-GIP001 in the Treatment of Drug-Resistant Unilateral Mesial Temporal Lobe Epilepsy
Phase 1
Not yet recruiting
12 enrolled
Shanghai UniXell Biotechnology Co., Ltd
Beijing Tiantan Hospital · collabThe First Affiliated Hospital of Zhengzhou University · collabWest China Hospital · collab
NaSingle-groupOpen-labelTreatment
Summary
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.
Timeline
- Start
- 2026-05-20
- Primary completion
- 2029-07-01
- Completion
- 2029-07-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | UX-GIP001 | Cell therapy | — | Other |