drugset / Trial / 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

NCT07485751 ↗

NaSingle-groupOpen-labelTreatment

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

Timeline

Start
2026-03
Primary completion
2026-09
Completion
2026-12

Drugs

EvaluationDrugModalityDoseRoute
Subject hDFSCs-Exo Other / unclassified 1e+09 unknown Intranasal
Subject hDFSCs-Exo Other / unclassified 2e+09 unknown Intranasal
Subject hDFSCs-Exo Other / unclassified 4e+09 unknown Intranasal
Subject hDFSCs-Exo Other / unclassified 8e+09 unknown Intranasal
Subject hDFSCs-Exo Other / unclassified 1.6e+10 unknown Intranasal

Indications