Ireland
--:--IST
Latest
Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: 2025 Eurostat Trade Data and Economic Impact Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: 2025 Eurostat Trade Data and Economic Impact
Recruiting Early Phase 1

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

NCT07244328 · tracked via the Priya Life Science China tracker
Phase
Early Phase 1
Started
2025-11-10
Last updated
2026-04-22

Condition(s) studied

EpilepsyMTLE

Investigational drug(s) / intervention(s)

UX-GIP001 →

UX-GIP001: Allogeneic human GABAergic interneuron precursors (UX-GIP001) are delivered into the temporal lobe region of the brain.

Study 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

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Incidence and severity of Adverse Events (AEs)/Serious Adverse Events (SAEs) — From baseline to 2 years post surgery

Trial sites (1)

FacilityCityRegionStatus
Second Affiliated Hospital, School of Medicine, Zhejiang University Hangzhou Zhejiang Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07244328 on ClinicalTrials.gov ↗ ← All trials in China