NCT07244328 Exploratory Study of UX-GIP001 Cell Therapy in Adult Patients With Drug-Resistant Unilateral Mesial Temporal Lobe Epilepsy (MTLE)
| NCT ID | NCT07244328 |
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Sponsor | Second Affiliated Hospital, School of Medicine, Zhejiang University |
| Condition | Epilepsy |
| Study Type | INTERVENTIONAL |
| Enrollment | 6 participants |
| Start Date | 2025-11-10 |
| Primary Completion | 2028-11-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 6 participants in total. It began in 2025-11-10 with a primary completion date of 2028-11-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Key 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. Key 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.
Contact & Investigator
Shuang Wang, Doctor
PRINCIPAL INVESTIGATOR
Second Affiliated Hospital, School of Medicine, Zhejiang University
Frequently Asked Questions
Who can join the NCT07244328 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Epilepsy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07244328 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07244328 currently recruiting?
Yes, NCT07244328 is actively recruiting participants. Contact the research team at 12418578@zju.edu.cn for enrollment information.
Where is the NCT07244328 trial being conducted?
This trial is being conducted at Hangzhou, China.
Who is sponsoring the NCT07244328 clinical trial?
NCT07244328 is sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University. The principal investigator is Shuang Wang, Doctor at Second Affiliated Hospital, School of Medicine, Zhejiang University. The trial plans to enroll 6 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.