EpilepsyPhase 1NCT07572812
A Phase I Clinical Trial of UX-GIP001 in the Treatment of Drug-Resistant Unilateral Mesial Temporal Lobe Epilepsy
A Phase 1 study testing UX-GIP001 in people with Epilepsy, run by Shanghai UniXell Biotechnology Co., Ltd at 3 sites in China.
Trial summary
This is a phase I study (Protocol: UX-GIP001-102) 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). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Epilepsy
- What is being tested?
- UX-GIP001
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 3 sitesChina
- Study dates
- 5 Sep 2026to 1 Jul 2029
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-75 years (inclusive), male or female;
- Diagnosis of focal epilepsy according to the International League Against Epilepsy (ILAE) 2025 epilepsy classification, with disease duration ≥2 years;
- Clinical presentation consistent with unilateral mesial temporal lobe epilepsy (MTLE);
- Meeting the diagnostic criteria for drug-resistant epilepsy;
- Average focal seizure frequency ≥4 per 28 days within the 3 months prior to screening;
- On a stable dose of anti-seizure medications for ≥1 month prior to enrollment;
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- Patient has adequate organ function as follows: absolute neutrophil count ≥2.0×10⁹/L; white blood cell count ≥4.0×10⁹/L; platelet count ≥100×10⁹/L; AST and ALT ≤2.5× upper limit of normal (ULN); total bilirubin ≤1.5× ULN; serum creatinine ≤1.5× ULN; estimated glomerular filtration rate (eGFR) ≥60 mL/min/1.73 m² (calculated using the CKD-EPI formula);
- Women of childbearing potential must have a negative serum pregnancy test during the screening period. All participants and their partners agree to have no plans for pregnancy, sperm donation, or egg donation from the time of signing the informed consent form until 2 years after cell transplantation treatment, and voluntarily adopt contraceptive measures deemed effective by the investigator;
- Patient has good compliance, with a patient diary completion rate ≥80% prior to enrollment.
Who cannot join
- Epilepsy caused by other/or progressive neurological diseases , or patients - experiencing only focal aware seizures without observable manifestations.
- History of epilepsy surgery.
- History of status epilepticus within 12 months prior to screening.
- Presence of long-term implants in the skull or intracranial space.
- Severe systemic disease or dysfunction.
- Primary or secondary immunodeficiency.
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- History of clear suicidal intent, plan, or behavior within one year prior to screening.
- Severe psychiatric disorders.
- 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.
- Pregnant or breastfeeding women.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China3 sites, 3 recruiting
- Recruiting
Beijing Tiantan Hospital, Capital Medical University
Beijing, Beijing Municipality, 100070
Xiaoqiu Shao
- Recruiting
West China School of Medicine and West China Hospital, Sichuan University
Chengdu, Sichuan, 610041
Dong Zhou, Doctor
- Not yet recruiting
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450000
Qun Wang
About this study
Official title: A Phase I Clinical Trial to Evaluate the Safety, Tolerability, and Preliminary Efficacy of UX-GIP001 (Human GABAergic Interneuron Progenitor Cells Injection) in the Treatment of Drug-Resistant Unilateral Mesial Temporal Lobe Epilepsy
This is a phase I study (Protocol: UX-GIP001-102) 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.
Read the detailed description
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.
- Conditions
- Epilepsy
- Being tested
- UX-GIP001
- Keywords
- Epilepsy, MTLE, Cell therapy
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UX-GIP001Drug
Allogeneic human GABAergic interneuron precursors (UX-GIP001) are delivered into the temporal lobe region of the brain.
| Study group | Role | What they receive |
|---|---|---|
| UX-GIP001 | Experimental | Two dose levels will be planned. Each patient only receives one corresponding dose of UX-GIP001. Receives: Drug: UX-GIP001 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of Adverse Events (AEs)/Serious Adverse Events (SAEs)
Measured: From baseline to 6 Months post-treatment
Secondary outcomes (5)
Change from baseline in total and subtype seizure frequency
Measured: From baseline to 2 years post-treatment
Responder rates (≥50% and ≥75% reduction) in total and subtype seizure frequency
Measured: From baseline to 2 years post-treatment
Seizure free rate
Measured: From baseline to 2 years post-treatment
Incidence and severity of AEs/SAEs related to surgery, transplanted cells, and/or immunosuppressive therapy
Measured: From baseline to 2 years post-treatment
Incidence and severity of all AEs/SAEs
Measured: From baseline to 2 years post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2026
- Study start5 Sep 2026
- Primary completion1 Jul 2029 (estimated)
- Study completion1 Jul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- open-label, multi-center, dose-escalation and dose-expansion
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai UniXell Biotechnology Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- West China Hospital, Beijing Tiantan Hospital, The First Affiliated Hospital of Zhengzhou University
- Responsible party
- Sponsor
- Investigators
- Dong Zhou, Doctor, Principal investigator, West China HospitalXiaoqiu Shao, Doctor, Principal investigator, Beijing Tiantan HospitalQun Wang, Doctor, Principal investigator, The First Affiliated Hospital of Zhengzhou University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07572812
- Sponsor's protocol ID
- UX-GIP001-102
- Status last verified
- Apr 2026
- First submitted
- 17 Apr 2026
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Clinical Trial to Evaluate the Safety, Tolerability, and Preliminary Efficacy of UX-GIP001 (Human GABAergic Interneuron Progenitor Cells Injection) in the Treatment of Drug-Resistant Unilateral Mesial Temporal Lobe Epilepsy
- ClinicalTrials.gov ID
- NCT07572812
- Acronym / sponsor ID
- UX-GIP001-102
- Conditions
- Epilepsy
- Keywords
- Epilepsy, MTLE, Cell therapy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Shanghai UniXell Biotechnology Co., LtdIndustry (pharma, biotech, devices)
- Collaborators
- West China Hospital, Beijing Tiantan Hospital, The First Affiliated Hospital of Zhengzhou University
- Study start
- 5 Sep 2026 (actual)
- Primary completion
- 1 Jul 2029 (estimated)
- Study completion
- 1 Jul 2029 (estimated)
- First posted
- 7 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a phase I study (Protocol: UX-GIP001-102) 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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- open-label, multi-center, dose-escalation and dose-expansion
| Arm | Type | Receives |
|---|---|---|
| UX-GIP001 | Experimental | Drug: UX-GIP001Two dose levels will be planned. Each patient only receives one corresponding dose of UX-GIP001. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age 18-75 years (inclusive), male or female;
- Diagnosis of focal epilepsy according to the International League Against Epilepsy (ILAE) 2025 epilepsy classification, with disease duration ≥2 years;
- Clinical presentation consistent with unilateral mesial temporal lobe epilepsy (MTLE);
- Meeting the diagnostic criteria for drug-resistant epilepsy;
- Average focal seizure frequency ≥4 per 28 days within the 3 months prior to screening;
Key exclusion criteria (10 listed)
- Epilepsy caused by other/or progressive neurological diseases , or patients - experiencing only focal aware seizures without observable manifestations.
- History of epilepsy surgery.
- History of status epilepticus within 12 months prior to screening.
- Presence of long-term implants in the skull or intracranial space.
- Severe systemic disease or dysfunction.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| UX-GIP001Allogeneic human GABAergic interneuron precursors (UX-GIP001) are delivered into the temporal lobe region of the brain. | Drug | UX-GIP001 |
Primary outcome
Incidence and severity of Adverse Events (AEs)/Serious Adverse Events (SAEs)
Time frame: From baseline to 6 Months post-treatment
5 secondary outcomes
Change from baseline in total and subtype seizure frequency
Time frame: From baseline to 2 years post-treatment
Responder rates (≥50% and ≥75% reduction) in total and subtype seizure frequency
Time frame: From baseline to 2 years post-treatment
Seizure free rate
Time frame: From baseline to 2 years post-treatment
Incidence and severity of AEs/SAEs related to surgery, transplanted cells, and/or immunosuppressive therapy
Time frame: From baseline to 2 years post-treatment
Incidence and severity of all AEs/SAEs
Time frame: From baseline to 2 years post-treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Dong Zhou, Doctor principal investigator
West China Hospital
Xiaoqiu Shao, Doctor principal investigator
Beijing Tiantan Hospital
Qun Wang, Doctor principal investigator
The First Affiliated Hospital of Zhengzhou University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing UX-GIP001 in people with Epilepsy, run by Shanghai UniXell Biotechnology Co., Ltd at 3 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xianwei Zhi (+86-21-60197620, xianweizhi@unixell.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and severity of Adverse Events (AEs)/Serious Adverse Events (SAEs) (time frame: From baseline to 6 Months post-treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2026.