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

NCT07485751 | Not Yet Recruiting Early Phase 1 DMC

• 1 other identifier: 20260101
• Study Type: interventional
• Target: 15
• Locations: 0 countries
• Sites: N/A

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 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

Conditions

Schizophrenia Negative Type

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (8)

• 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

Other Outcomes (2)

• Changes in the functional connections of brain networks in MRI

  week 0, 8

• The change in the concentration of oxygenated hemoglobin (Oxy-Hb) in fNIRS

  week 0, 8

Study Arms (1)

hDFSCs-Exo

EXPERIMENTAL

Biological: hDFSCs-Exo

Interventions

hDFSCs-Exo BIOLOGICAL

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

hDFSCs-Exo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• \) 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.

You may not qualify if:

• \) 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.

Sponsors & Collaborators

• Zigong Mental Health Center: lead
• Chengdu Celincare Biotechnology Co., Ltd.: collaborator

Central Study Contacts

Zigong Mental Health Center

CONTACT

+86 15881342476; liubo2511@163.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2026
• First Posted: March 20, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 20, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share