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Safety and Feasibility of Nasal Delivery of Human Dental Follicle Mesenchymal Stem Cell-Derived Exosomes for Negative Symptoms in Treatment-Resistant Schizophrenia: A Pilot Study Early Phase 1 15
Is the safety of the exosomes enough for participants? Is the feasibility of ...
Show MoreSafety and Feasibility of Nasal Delivery of Human Dental Follicle Mesenchymal Stem Cell-Derived Exosomes for Negative Symptoms in Treatment-Resistant Schizophrenia: A Pilot Study
- 20260101
| Participant Group/Arm | Intervention/Treatment |
|---|---|
ExperimentalhDFSCs-Exo | hDFSCs-Exo Nasal delivery of exosomes derived from human dental follicle mesenchymal stem cells (1×10\^9, 2×10\^9, 4×10\^9, 8×10\^9, 16×10\^9) twice weekly for eight weeks |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
The incidence and severity of adverse events (AE) and serious adverse events (SAE). | week 0, 2, 4, 8, 12, 16, 20, and 24 | |
Incidence of dose-limiting toxicity (DLT) | Specific toxic reactions related to the investigational drug that occur during the DLT observation period (within 28 days after a single administration) | The observation period for DLT is within 28 days after a single administration |
The incidence rate of abnormal laboratory tests | Blood routine, liver and kidney function (elevated ALT/AST, elevated creatinine, etc.), myocardial enzyme spectrum, inflammatory factors, allergic indicators (IgE) | Week 0, 2, 4, 8, 12, 16, 20, and 24 |
The incidence of abnormal vital signs and electrocardiogram (ECG) | Week 0, 2, 4, 8, 12, 16, 20, and 24 | |
Drug administration completion rate | week 8 |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Changes in the total score and negative symptom factor score of the PANSS scale | week 0, 4, 8, 12, and 24 | |
Changes in the total score and subscale scores of SANS (Negative Symptom Rating Scale) | week 0, 4, 8, 12, and 24 | |
Changes in the Clinical General Impression Scale - Severity (CGI-S) score | Week 0, 4, 8, 12, 24 | |
Changes in the Calgary Schizophrenia and Depression Scale (CDSS) score | Week 0, 4, 8, 12, 24 | |
Changes in the Montreal Cognitive Assessment Scale (MoCA) score | week 0, 4, 8, 12, 24 | |
Changes in the completion time of connection test A/B (TMT-A/B) | week 0, 4, 8, 12, 24 | |
Score changes of the Digit Span Test | week 0, 4, 8, 12, 24 | |
Changes in Language Learning and Memory Test (VLMT) scores | week 0, 4, 8, 12, 24 |
1) Conforms to the ICD-10 diagnosis of schizophrenia; 2) age between 18 and 60 years old; 3) course of more than 5 years of long-term inpatients; 4) the last 6 months without acute aggravating period, and no change in recent two months regimen; 5) to including clozapine, two different antipsychotics enough poor foot therapy treatment response; 6) positive and negative symptoms scale - negative symptom factor (PANSS - FSNS) 24 or more; 7) three core of PANSS negative symptoms (N1, N4 interchange and N6) at least 2 or 4; 6) clinical overall impression scale - illness severity (-s) CGI score of 4 or more points; 7) signed a written informed consent.