Exploratory Clinical Study on Induced Pluripotent Stem Cell Derived Exosomes (GD-iEXo-002) Nasal Drops for the Treatment of Refractory Focal Epilepsy

K2153-K22C1488

Evaluate the safety, tolerability, and preliminary efficacy of GD-iEXo-002 nasal drops in the treatment of focal refractory epilepsy

2023-06-05

2025-06-13

2025-11-13

Recruiting

Early phase I

34

Inclusion Criteria: 1. Before conducting this study, understand and sign the informed consent form and comply with the requirements of this study; 2. The subjects are patients with focal epilepsy aged 18 to 70 years (inclusive), regardless of gender; 3. The subjects must comply with the definition of drug resistant epilepsy (ILAE); 4. Subjects must take 1-6 types of anti-epileptic drugs (AEDs), and before entering the screening period, they must take unadjusted types and stable doses of AEDs for at least 4 weeks; 5. Throughout the entire research process, the subject/legal guardian must be able to accurately record the log of epileptic seizures; 6. Subjects must experience at least 4 countable seizures within 28 days prior to the screening period; 7. The subjects are willing and able to comply with the research requirements. Exclusion Criteria: 1. Unwilling or unable to follow the procedures stipulated in the agreement; 2. Pregnant or lactating women, or women with reproductive potential who are unable or unwilling to take appropriate contraceptive measures; 3. Other uncontrollable diseases that may interfere with the research results, including but not limited to infection, hypertension, diabetes, cardiovascular and cerebrovascular diseases, etc; 4. There are situations that may increase the risk of participating in experiments or research product use, such as liver enzyme elevation exceeding twice the normal upper limit and/or GFR\<60 mL/min/1.73 m2; 5. Have a history of drug abuse, alcohol dependence, or smoking within one month; 6. Patients with status epilepticus within one month; 7. Have potential progressive nervous system disease, such as encephalitis, brain tumor, multiple sclerosis or dementia; 8. Patients who plan to undergo epilepsy surgery within six months; 9. Patients with abnormal or diseased nasal structures; 10. Patients with cerebrospinal fluid rhinorrhea; 11. Patients whose family members have not been able to proficiently and correctly master the nasal drip method through standardized training

{'studyType': 'INTERVENTIONAL', 'phases': ['EARLY_PHASE1'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 34, 'type': 'ESTIMATED'}}

2023-06-07