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NOT YET RECRUITING
NCT07131683
PHASE1/PHASE2

hUC-MSC-Exo Therapy for Autoimmune Encephalitis

Sponsor: Xuanwu Hospital, Beijing

View on ClinicalTrials.gov

Summary

This is a phase I/IIa study to investigate the safety and preliminary efficacy of intranasal admnistration of human umbilical mesenchymal stem cell-derived exosome (hUC-MSC-Exo) for patients with autoimmune encephalitis.

Official title: Human Umbilical Cord Mesenchymal Stem Cell-derived ExoSomes for Autoimmune Encephalitis: a Phase I/IIa Clinical Trial (MESAE)

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

38

Start Date

2025-11-01

Completion Date

2027-08-31

Last Updated

2025-08-20

Healthy Volunteers

No

Interventions

BIOLOGICAL

Human umbilical cord mesenchymal stem cell derived exosomes

Nasal spray of hUC-MSC-Exo (low dose: 2.5×10\^10 particles, mid-dose: 5.0×10\^10 particles, high-dose: 1.0×10\^11 particles), once per day for 7 days, then once per week for 3 weeks

OTHER

Placebo Control

Nasal spray of placebo control, once per day for 7 days, then once per week for 3 weeks