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

Обзор

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

Вмешательства

• Биопрепарат 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

Первичные конечные точки

• The incidence and severity of adverse events (AE) and serious adverse events (SAE). [Срок оценки: week 0, 2, 4, 8, 12, 16, 20, and 24]
• Incidence of dose-limiting toxicity (DLT) [Срок оценки: The observation period for DLT is within 28 days after a single administration]
• The incidence rate of abnormal laboratory tests [Срок оценки: Week 0, 2, 4, 8, 12, 16, 20, and 24]
• The incidence of abnormal vital signs and electrocardiogram (ECG) [Срок оценки: Week 0, 2, 4, 8, 12, 16, 20, and 24]
• Drug administration completion rate [Срок оценки: week 8]

Вторичные конечные точки (8)

• Changes in the total score and negative symptom factor score of the PANSS scale [Срок оценки: week 0, 4, 8, 12, and 24]
• Changes in the total score and subscale scores of SANS (Negative Symptom Rating Scale) [Срок оценки: week 0, 4, 8, 12, and 24]
• Changes in the Clinical General Impression Scale - Severity (CGI-S) score [Срок оценки: Week 0, 4, 8, 12, 24]
• Changes in the Calgary Schizophrenia and Depression Scale (CDSS) score [Срок оценки: Week 0, 4, 8, 12, 24]
• Changes in the Montreal Cognitive Assessment Scale (MoCA) score [Срок оценки: week 0, 4, 8, 12, 24]
• Changes in the completion time of connection test A/B (TMT-A/B) [Срок оценки: week 0, 4, 8, 12, 24]
• Score changes of the Digit Span Test [Срок оценки: week 0, 4, 8, 12, 24]
• Changes in Language Learning and Memory Test (VLMT) scores [Срок оценки: week 0, 4, 8, 12, 24]

Критерии участия

Критерии включения

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.

Критерии исключения

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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07485751 · 20260101

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗