Clinical trial of autologous olfactory mucosa mesenchymal stromal cells in the treatment of refractory epilepsy

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2200055357

Enrollment

Unknown

Registered

2022-01-08

Start date

2014-01-01

Completion date

Unknown

Last updated

2023-01-30

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

Conditions

Refractory epilepsy

Interventions

Control group:Placebo treatment + conventional treatment for refractory epilepsy

Treatment group:Autologous olfactory mucosa mesenchymal stromal cell therapy + conventional refractory epilepsy therapy

Eligibility

Sex/Gender

All

Age

18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18-60 years, gender is not limited; 2. According to Chinese diagnostic criteria for adult intractable epilepsy, including: regular system application of two or more antiepileptic drugs (AEDs) regular treatment, and the blood concentration is within the effective range, and the seizures cannot be controlled after at least two years of observation (with seizures every month), which affects daily life; 3. Normal bone marrow hematopoietic function, no bleeding tendency, blood routine: HGB>=90g/L, WBC>4.0x10^9/L (NEU>=1.5x10^9/L), PLT>=100x10^9/L ; 4. Liver function: total bilirubin =80mL/min; 6. There is no evidence of acute inflammatory infection on chest CT; 7. No other serious heart, liver, kidney disease, etc.; 8. No serious viral or bacterial infection; 9. Patients or legal representatives agree to participate in this study and sign the informed consent.

Exclusion criteria

Exclusion criteria: 1. Unable to cooperate with patients who refuse EEG testing and imaging testing; 2. Highly allergic or have a history of severe allergies; 3. Those with mental or psychological diseases who cannot cooperate with treatment and efficacy evaluation; 4. Patients with systemic infection or severe local infection requiring anti-infective treatment; 5. Coagulation disorders (such as hemophilia); 6. Infectious diseases (such as HIV, RPR, active tuberculosis, etc.); 7. Patients with severe autoimmune diseases; 8. The investigator believes that there are other reasons for not being able to be included in the treatment; 9. Those who cannot comply with the research requirements; 10. Pregnant or lactating patients.

Design outcomes

Primary

Measure	Time frame
Dynamic EEG;	—

Secondary

Measure	Time frame
Cranial MRI;Symptoms of seizures;	—

Countries

China

Contacts

Public ContactHuang Yan

The Second Affiliated Hospital of Hu'nan Normal University

huangyan880410@hotmail.com+86 13575146258

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 8, 2026