Exploratory Study of UX-GIP001 Cell Therapy in Adult Patients With Drug-Resistant Unilateral Mesial Temporal Lobe Epilepsy (MTLE)

NCT ID: NCT07244328

Last Updated: 2025-11-24

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-11-15
• Study Completion Date: 2028-11-30

Brief 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.

Detailed Description

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.

Conditions

Epilepsy; MTLE

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

UX-GIP001

Two dose levels will be planned. Each patient only receives one corresponding dose of UX-GIP001.

Group Type: EXPERIMENTAL

UX-GIP001

Intervention Type: BIOLOGICAL

Allogeneic human GABAergic interneuron precursors (UX-GIP001) are delivered into the temporal lobe region of the brain.

Interventions

UX-GIP001

Allogeneic human GABAergic interneuron precursors (UX-GIP001) are delivered into the temporal lobe region of the brain.

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

1. Age 18-75 (inclusive), male or female.

2. Clinical presentation consistent with unilateral mesial temporal lobe epilepsy (MTLE).

3. Has failed to achieve seizure control despite treatment with at least two anti-seizure medications (ASMs) at recommended or maximally tolerated doses.

4. Average focal seizure frequency ≥4 per 28 days during the 3 months prior to screening.

5. Stable doses of ASMs for ≥1 month prior to enrollment.

6. Patient is in good general health or has stable comorbid conditions, and has adequate organ function.

Exclusion Criteria

1. Epilepsy caused by other/or progressive neurological diseases , or patients experiencing only focal aware seizures without observable manifestations.

2. History of epilepsy surgery.

3. History of status epilepticus within 12 months prior to screening.

4. Presence of long-term implants in the skull or intracranial space.

5. Severe systemic disease or dysfunction.

6. Primary or secondary immunodeficiency.

7. History of clear suicidal intent, plan, or behavior within one year prior to screening.

8. Severe psychiatric disorders.

9. History of malignancy within the past 5 years, except for cervical carcinoma in situ, basal cell or squamous cell skin cancer cured for >5 years.

10. Pregnant or breastfeeding women.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai UniXell Biotechnology Co., Ltd

INDUSTRY

Sponsor Role: collaborator

Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Shuang Wang, Doctor

Role: PRINCIPAL_INVESTIGATOR

Second Affiliated Hospital, School of Medicine, Zhejiang University

Junming Zhu, Doctor

Role: PRINCIPAL_INVESTIGATOR

Second Affiliated Hospital, School of Medicine, Zhejiang University

Locations

Second Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, China

Countries

China

Central Contacts

Yuyu Yang

Role: CONTACT

12418578@zju.edu.cn

+8615036965416

Facility Contacts

Yuyu Yang

Role: primary

12418578@zju.edu.cn

+8615036965416

Other Identifiers

2025-0876

Identifier Type: -

Identifier Source: org_study_id