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Clinical Trial NCT07485751 for Schizophrenia Negative Type is not yet recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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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

Not yet recruiting
Clinical Trial NCT07485751 is designed to study Treatment for Schizophrenia Negative Type. This Early Phase 1 interventional study is not yet recruiting. Enrollment is planned to begin on March 1, 2026 until the study accrues 15 participants. Led by Zigong Mental Health Center, this study is expected to complete by December 1, 2026. The latest data from ClinicalTrials.gov was last updated on March 20, 2026.
Brief Summary
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 ...

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Official Title

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

Conditions
Schizophrenia Negative Type
Other Study IDs
  • 20260101
NCT ID Number
Start Date (Actual)
2026-03
Last Update Posted
2026-03-20
Completion Date (Estimated)
2026-12
Enrollment (Estimated)
15
Study Type
Interventional
PHASE
Early Phase 1
Status
Not yet recruiting
Primary Purpose
Treatment
Design Allocation
N/A
Interventional Model
Single Group
Masking
None (Open Label)
Arms / Interventions
Participant Group/ArmIntervention/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
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime 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
Secondary Outcome Measures
Outcome MeasureMeasure DescriptionTime 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
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult
Minimum Age
18 Years
Eligible Sexes
All

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.

1) Has a history of severe allergies; 2) there is a clear brain organic disease; 3) with serious body disease (such as the instability of coronary artery disease, malignant arrhythmia, liver and kidney function is not complete, bronchial asthma, COPD acute aggravating period, autoimmune diseases, etc.); 4) there is accord with the ICD - 10 patients with other psychiatric diagnosis standard sample obstacles (such as schizoaffective disorder, schizophrenia, bipolar I disorder, bipolar type Ⅱ dysfunction, broad developmental disabilities, mental retardation, delirium, dementia, forgotten obstacles or other cognitive impairment, etc.); 5) condition fluctuation, the need to adjust the drug solution; 6) don't cooperate with treatment, 7) with severe rhinitis, nasal allergies; 8) for nearly three months has a history of MECT therapy; 9) suicide risk; 10) during pregnancy or lactation women, female or male subjects and spouse has pregnancy at the time of test plan or over 3 months to test is not willing to use effective contraception (effective contraceptive measures such as birth control pills and condoms or intrauterine device, etc.); 11) other unfavorable into groups.
Zigong Mental Health Center logoZigong Mental Health Center
Chengdu Celincare Biotechnology Co., Ltd. logoChengdu Celincare Biotechnology Co., Ltd.
Study Central Contact
Contact: Zigong Mental Health Center, +86 15881342476, [email protected]
No location data.