Induced Pluripotent Stem Cell Derived Exosomes Nasal Drops for the Treatment of Refractory Focal Epilepsy

• Status: Recruiting
• Trial end date: 2025-11-13
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Peking Union Medical College Hospital
• Collaborator: Guidon Pharmaceutics Ltd.

Criteria

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