Cell therapy for adults with epilepsy that medicines do not control
Tests UX-GIP001 cell therapy in adults with drug-resistant mesial temporal lobe epilepsy.
Plain-language title generated from the registry record
Registry title: Exploratory Study of UX-GIP001 Cell Therapy in Adult Patients With Drug-Resistant Unilateral Mesial Temporal Lobe Epilepsy (MTLE)
Key facts
- Where
- Hangzhou, ChinaSee the site
- Phase
- Early phase 1
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Source: NCT07244328, who can take part
Where in China
- Second Affiliated Hospital, School of Medicine, Zhejiang UniversityHangzhou, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Second Affiliated Hospital, Zhejiang University, School of Medicine
- Trial code
- NCT07244328
- Record updated
- 22 April 2026
- Original description
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.Read full original descriptionShow less
An Exploratory Clinical Trial of UX-GIP001 Injection (Human GABAergic Interneuron Progenitor Cells Injection) in Adult Patients With Drug-Resistant Unilateral Mesial Temporal Lobe Epilepsy
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.
Inclusion: Age 18-75 (inclusive), male or female; Clinical presentation consistent with unilateral mesial temporal lobe epilepsy (MTLE); Has failed to achieve seizure control despite treatment with at least two anti-seizure medications (ASMs) at recommended or maximally tolerated doses; Average focal seizure frequency ≥4 per 28 days during the 3 months prior to screening; Stable doses of ASMs for ≥1 month prior to enrollment; Patient is in good general health or has stable comorbid conditions, and has adequate organ function.
Exclusion: History of status epilepticus within 12 months prior to screening; Presence of long-term implants in the skull or intracranial space; History of clear suicidal intent, plan, or behavior within one year prior to screening; Epilepsy caused by other/or progressive neurological diseases , or patients experiencing only focal aware seizures without observable manifestations; History of epilepsy surgery; Severe systemic disease or dysfunction; Severe psychiatric disorders; 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; Primary or secondary immunodeficiency; Pregnant or breastfeeding women.