Actively Recruiting
Exploratory Study of UX-GIP001 Cell Therapy in Adult Patients With Drug-Resistant Unilateral Mesial Temporal Lobe Epilepsy (MTLE)
Led by Second Affiliated Hospital, School of Medicine, Zhejiang University · Updated on 2026-04-22
6
Participants Needed
1
Research Sites
159 weeks
Total Duration
On this page
Sponsors
S
Second Affiliated Hospital, School of Medicine, Zhejiang University
Lead Sponsor
S
Shanghai UniXell Biotechnology Co., Ltd
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Exploratory Study of UX-GIP001 Cell Therapy in Adult Patients With Drug-Resistant Unilateral Mesial Temporal Lobe Epilepsy (MTLE)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 75 years, male or female
- Diagnosis consistent with unilateral mesial temporal lobe epilepsy (MTLE)
- Has not achieved seizure control despite treatment with at least two anti-seizure medications at recommended or maximally tolerated doses
- Average of 4 or more focal seizures per 28 days during the 3 months before screening
- Stable doses of anti-seizure medications for at least 1 month before enrollment
- Good general health or stable comorbid conditions with adequate organ function
You will not qualify if you...
- Epilepsy caused by other or progressive neurological diseases, or only focal aware seizures without observable symptoms
- 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
- Severe systemic disease or dysfunction
- Primary or secondary immunodeficiency
- History of suicidal intent, plan, or behavior within 1 year prior to screening
- Severe psychiatric disorders
- History of cancer within the past 5 years except certain skin cancers cured for over 5 years
- Pregnant or breastfeeding women
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Second Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, China, 310009
Actively Recruiting
Research Team
Y
Yang, Doctor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here