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| Name | Class |
|---|---|
| Shanghai UniXell Biotechnology Co., Ltd | INDUSTRY |
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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.
Participants will receive UX-GIP001 via stereotactic neurosurgery, preceded by and followed with immunosuppressive therapy. The study includes a baseline period for eligibility confirmation and a 24-month follow-up phase involving regular safety assessments, neuroimaging , seizure diary logging, and evaluations of quality of life, cognition, and mood. This pioneering regenerative approach seeks to provide a new treatment strategy for drug-resistant MTLE by addressing the underlying pathophysiology.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| UX-GIP001 | Experimental | Two dose levels will be planned. Each patient only receives one corresponding dose of UX-GIP001. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| UX-GIP001 | Biological | Allogeneic human GABAergic interneuron precursors (UX-GIP001) are delivered into the temporal lobe region of the brain. |
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| Measure | Description | Time Frame |
|---|---|---|
| Incidence and severity of Adverse Events (AEs)/Serious Adverse Events (SAEs) | From baseline to 2 years post surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in total and subtype seizure frequency | From baseline to 2 years post surgery | |
| Responder rates (≥50% and ≥75% reduction) in total and subtype seizure frequency | From baseline to 2 years post surgery |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yang, Doctor | Contact | +86 132 0571 6189 | 12418578@zju.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Shuang Wang, Doctor | Second Affiliated Hospital, School of Medicine, Zhejiang University | Principal Investigator |
| Junming Zhu, Doctor | Second Affiliated Hospital, School of Medicine, Zhejiang University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Second Affiliated Hospital, School of Medicine, Zhejiang University | Recruiting | Hangzhou | Zhejiang | 310009 | China |
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open-label, single-center, dose-escalation and dose-expansion
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| Seizure free rate | From baseline to 2 years post surgery |
| ID | Term |
|---|---|
| D004827 | Epilepsy |
| D000069279 | Drug Resistant Epilepsy |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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