The goal of this clinical trial is to determine the safety and feasibility of nasal delivery of human dental follicle mesenchymal stem cell-derived exosomes in the treatment of negative symptoms of treatment-resistant schizophrenia. It will also learn about the preliminary efficacy of the exosomes. The main questions it aims to answer are: Is the safety of the exosomes enough for participants? Is the feasibility of nasal delivery of exosomes for participants? Do the exosomes exert any benefits on the negative symptoms of treatment-resistant schizophrenia? Participants will: Take a nasal spray of exosomes twice weekly for 2 months Take vital sign checks every day, regular visits for an interview, and lab examinations
Age range
18 Years – 60 Years
Sex
ALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
The incidence and severity of adverse events (AE) and serious adverse events (SAE).
Timeframe: week 0, 2, 4, 8, 12, 16, 20, and 24
Incidence of dose-limiting toxicity (DLT)
Timeframe: The observation period for DLT is within 28 days after a single administration
The incidence rate of abnormal laboratory tests
Timeframe: Week 0, 2, 4, 8, 12, 16, 20, and 24
The incidence of abnormal vital signs and electrocardiogram (ECG)
Timeframe: Week 0, 2, 4, 8, 12, 16, 20, and 24
Drug administration completion rate
Timeframe: week 8