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Treatment of children epileptic encephalopathy with iPSC derived exosomes (GD-iExo-002): a clinical exploratory study

Treatment of children epileptic encephalopathy with iPSC derived exosomes (GD-iExo-002): a clinical exploratory study

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400091107
Enrollment
Unknown
Registered
2024-10-21
Start date
2024-03-25
Completion date
Unknown
Last updated
2024-10-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

children epileptic encephalopathy

Interventions

Experimental group:iPSC derived exosomes and standard anti-epileptic drugs
Control: Saline and standard anti-epileptic drugs

Sponsors

Capital Institute of Pediatrics
Lead Sponsor

Eligibility

Sex/Gender
All
Age
2 Years to 12 Years

Inclusion criteria

Inclusion criteria: (1) Before conducting this study, understand and sign the informed consent and comply with the requirements of this study; (2) Children with epileptic encephalopathy, aged 2-12 years old, regardless of gender; (3) The number of seizures per week for patients shall not be less than 3; (4) Electroencephalography records at least one habitual seizure in patients.

Exclusion criteria

Exclusion criteria: (1) Epilepsy caused by clear and treatable causes (such as brain tumors, metabolic diseases, etc.); (2) Patients with severe infections, multiple organ failure, severe pneumonia, etc; (3) Patients with abnormal or diseased nasal structures; (4) Patients with cerebrospinal fluid rhinorrhea; (5) Patients whose family members have not been able to proficiently and correctly master the nasal drip method through standardized training; (6) Nasal drops are transported to the patient's residential address through conventional cold chain transportation, which cannot meet the requirements of freezing.

Design outcomes

Primary

MeasureTime frame
Seizure frequency;adverse event;

Countries

China

Contacts

Public ContactFeng Shuo

Capital Institute of pediatrics

15210202122@163.com+86 152 1020 2122

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026