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NOT YET RECRUITING
NCT07485751
EARLY_PHASE1

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: Zigong Mental Health Center

View on ClinicalTrials.gov

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

Key Details

Gender

All

Age Range

18 Years - 60 Years

Study Type

INTERVENTIONAL

Enrollment

15

Start Date

2026-03

Completion Date

2026-12

Last Updated

2026-03-20

Healthy Volunteers

No

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