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

RecruitingEARLY Phase 1Ages 18 Years - 75 YearsAllSecond Affiliated Hospital, Zhejiang University, โ€ฆ
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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 โ‰ฅ4 per 28 days during the 3 months prior to screening. 5. Stable doses of ASMs for โ‰ฅ1 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.
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What it tests

  • UX-GIP001
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Where

1 site
Second Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, China
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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