UX-GIP001 cell therapy for adults with drug-resistant unilateral mesial temporal lobe epilepsy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This open-label, single-arm early-phase study delivers UX-GIP001, a preparation of human GABAergic interneuron progenitor cells, via stereotactic neurosurgery with perioperative immunosuppression. All participants receive the active cell therapy and outcomes after transplant will be compared to each patient's pre-transplant baseline for seizure frequency and safety. The protocol includes a baseline eligibility period followed by a 24-month follow-up with regular safety assessments, neuroimaging, seizure diary logging, and evaluations of quality of life, cognition, and mood. The main goals are to characterize safety and tolerability and to gather preliminary evidence of seizure reduction.

Why it matters

Who can join: the full rules

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.

Where it's running

• Second Affiliated Hospital, School of Medicine, Zhejiang University
  Hangzhou, Zhejiang, China Recruiting

Study contacts

• Principal investigator: Shuang Wang, Doctor — Second Affiliated Hospital, Zhejiang University, School of Medicine
• Study coordinator: Yang, Doctor
• Email: 12418578@zju.edu.cn
• Phone: +86 132 0571 6189

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.