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A Real-World Study on the Efficacy and Safety of Exosome Therapy for Treatment-Resistant Schizophrenia

A Real-World Study on the Efficacy and Safety of Exosome Therapy for Treatment-Resistant Schizophrenia

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500112760
Enrollment
Unknown
Registered
2025-11-19
Start date
2025-12-01
Completion date
Unknown
Last updated
2025-11-24

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

Conditions

Treatment-resistant schizophrenia

Interventions

Exosome Treatment group:Extracellular vesicles derived from mesenchymal stem cells

Sponsors

The Third People's Hospital of Foshan (Foshan Mental Health Center)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1.Meet the diagnostic criteria for schizophrenia according to either the "ICD-10" or the "DSM-5"; 2.Fulfill the definition of treatment-resistant schizophrenia (i.e., lack of satisfactory response to adequate dose and duration treatment with at least two different classes of antipsychotic drugs); 3.Aged 18 to 60 years, regardless of gender; 4.Have provided signed informed consent and voluntarily agree to participate in the study.

Exclusion criteria

Exclusion criteria: 1.Presence of severe somatic diseases (e.g., hepatic or renal failure); 2.Significant history of substance dependence or abuse; 3.Pregnancy or lactation; 4.Contraindications to MRI; 5.Previous treatment with stem cell or exosome therapy.

Design outcomes

Primary

MeasureTime frame
Positive and Negative Syndrome Scale Score ;

Secondary

MeasureTime frame
Bech-Rafaelsdn Mania Rating Scale Score ;Magnetic Resonance Imaging;Changes in Inflammatory Factor Levels;Montreal Cognitive Assessment Score ;Adverse Event;Hamilton Depression Scale Score ;Changes in Immune Function Parameters;Hamilton Anxiety Scale Score ;

Countries

China

Contacts

Public ContactRunyi Li

The Third People's Hospital of Foshan (Foshan Mental Health Center)

85091419@qq.com+86 757 83168445

Outcome results

None listed

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