Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-31 @ 8:15 AM
Study NCT ID:
NCT07485751
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-20
First Post:
2026-03-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief 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
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2026-01-26', 'size': 404959, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2026-03-16T05:06', 'hasProtocol': True}, {'date': '2026-01-26', 'size': 174146, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2026-03-16T05:42', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 15}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-03', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-16', 'studyFirstSubmitDate': '2026-03-16', 'studyFirstSubmitQcDate': '2026-03-16', 'lastUpdatePostDateStruct': {'date': '2026-03-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Changes in the functional connections of brain networks in MRI', 'timeFrame': 'week 0, 8'}, {'measure': 'The change in the concentration of oxygenated hemoglobin (Oxy-Hb) in fNIRS', 'timeFrame': 'week 0, 8'}], 'primaryOutcomes': [{'measure': 'The incidence and severity of adverse events (AE) and serious adverse events (SAE).', 'timeFrame': 'week 0, 2, 4, 8, 12, 16, 20, and 24'}, {'measure': 'Incidence of dose-limiting toxicity (DLT)', 'timeFrame': 'The observation period for DLT is within 28 days after a single administration', 'description': 'Specific toxic reactions related to the investigational drug that occur during the DLT observation period (within 28 days after a single administration)'}, {'measure': 'The incidence rate of abnormal laboratory tests', 'timeFrame': 'Week 0, 2, 4, 8, 12, 16, 20, and 24', 'description': 'Blood routine, liver and kidney function (elevated ALT/AST, elevated creatinine, etc.), myocardial enzyme spectrum, inflammatory factors, allergic indicators (IgE)'}, {'measure': 'The incidence of abnormal vital signs and electrocardiogram (ECG)', 'timeFrame': 'Week 0, 2, 4, 8, 12, 16, 20, and 24'}, {'measure': 'Drug administration completion rate', 'timeFrame': 'week 8'}], 'secondaryOutcomes': [{'measure': 'Changes in the total score and negative symptom factor score of the PANSS scale', 'timeFrame': 'week 0, 4, 8, 12, and 24'}, {'measure': 'Changes in the total score and subscale scores of SANS (Negative Symptom Rating Scale)', 'timeFrame': 'week 0, 4, 8, 12, and 24'}, {'measure': 'Changes in the Clinical General Impression Scale - Severity (CGI-S) score', 'timeFrame': 'Week 0, 4, 8, 12, 24'}, {'measure': 'Changes in the Calgary Schizophrenia and Depression Scale (CDSS) score', 'timeFrame': 'Week 0, 4, 8, 12, 24'}, {'measure': 'Changes in the Montreal Cognitive Assessment Scale (MoCA) score', 'timeFrame': 'week 0, 4, 8, 12, 24'}, {'measure': 'Changes in the completion time of connection test A/B (TMT-A/B)', 'timeFrame': 'week 0, 4, 8, 12, 24'}, {'measure': 'Score changes of the Digit Span Test', 'timeFrame': 'week 0, 4, 8, 12, 24'}, {'measure': 'Changes in Language Learning and Memory Test (VLMT) scores', 'timeFrame': 'week 0, 4, 8, 12, 24'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Schizophrenia Negative Type']}, 'descriptionModule': {'briefSummary': '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:\n\nIs 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?\n\nParticipants will:\n\nTake a nasal spray of exosomes twice weekly for 2 months Take vital sign checks every day, regular visits for an interview, and lab examinations'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1\\) 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.\n\nExclusion Criteria:\n\n1\\) 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."}, 'identificationModule': {'nctId': 'NCT07485751', 'briefTitle': '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', 'organization': {'class': 'OTHER', 'fullName': 'Zigong Mental Health Center'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': '20260101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'hDFSCs-Exo', 'interventionNames': ['Biological: hDFSCs-Exo']}], 'interventions': [{'name': 'hDFSCs-Exo', 'type': 'BIOLOGICAL', 'description': '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', 'armGroupLabels': ['hDFSCs-Exo']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Zigong Mental Health Center', 'role': 'CONTACT', 'email': 'liubo2511@163.com', 'phone': '+86 15881342476'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zigong Mental Health Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Chengdu Celincare Biotechnology Co., Ltd.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}