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hUC-MSC-Exo Therapy for Autoimmune Encephalitis

NCT07131683 · Status: NOT_YET_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2025-08-20

No results posted yet for this study

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.

Conditions

  • Autoimmune Encephalitis

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

Sponsors & Collaborators

  • ECHO Biotech

    collaborator UNKNOWN

  • Xuanwu Hospital, Beijing

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-11-01
Primary Completion
2027-06-30
Completion
2027-08-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07131683 on ClinicalTrials.gov