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Not yet recruiting NCT07485751

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 I Interventional Schizophrenia Negative Type

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: hDFSCs-Exo.
Who it may be relevant to
Registry conditions: Schizophrenia Negative Type. Basic parameters: 18 years — 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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

Interventions

  • Biological 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

  • The incidence and severity of adverse events (AE) and serious adverse events (SAE). [Time frame: week 0, 2, 4, 8, 12, 16, 20, and 24]
  • Incidence of dose-limiting toxicity (DLT) [Time frame: The observation period for DLT is within 28 days after a single administration]
  • The incidence rate of abnormal laboratory tests [Time frame: Week 0, 2, 4, 8, 12, 16, 20, and 24]
  • The incidence of abnormal vital signs and electrocardiogram (ECG) [Time frame: Week 0, 2, 4, 8, 12, 16, 20, and 24]
  • Drug administration completion rate [Time frame: week 8]
Secondary outcome measures (8)
  • Changes in the total score and negative symptom factor score of the PANSS scale [Time frame: week 0, 4, 8, 12, and 24]
  • Changes in the total score and subscale scores of SANS (Negative Symptom Rating Scale) [Time frame: week 0, 4, 8, 12, and 24]
  • Changes in the Clinical General Impression Scale - Severity (CGI-S) score [Time frame: Week 0, 4, 8, 12, 24]
  • Changes in the Calgary Schizophrenia and Depression Scale (CDSS) score [Time frame: Week 0, 4, 8, 12, 24]
  • Changes in the Montreal Cognitive Assessment Scale (MoCA) score [Time frame: week 0, 4, 8, 12, 24]
  • Changes in the completion time of connection test A/B (TMT-A/B) [Time frame: week 0, 4, 8, 12, 24]
  • Score changes of the Digit Span Test [Time frame: week 0, 4, 8, 12, 24]
  • Changes in Language Learning and Memory Test (VLMT) scores [Time frame: week 0, 4, 8, 12, 24]

Eligibility criteria

Inclusion criteria

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.

Exclusion criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07485751 · 20260101

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗