Full results & analysis
Available in the Gosset platform where reported.
Trial intelligence / Profile preview
MESAE: hUC-MSC-Exo for Autoimmune Encephalitis
NCT07131683Phase 2
Key facts
- Status
- Not yet recruiting
- Start
- Nov 2025
- Primary completion
- Jun 2027
- Sponsor
- Xuanwu Hospital
- Modality
- Lipid-based Nanoparticles, Cell Therapies
- Conditions
- Autoimmune Encephalitis (AE)
01
Overview
Phase 2, randomised, double-blind trial of human umbilical cord mesenchymal stem cell-derived exosomes in Autoimmune Encephalitis (AE) (5 arms), sponsored by Xuanwu Hospital. Primary endpoints: Dose-Limiting Toxicity events at 24 weeks and Modified Rankin Scale at 24 weeks. Planned start Nov 2025; status: not yet recruiting.
02
Design
5 arms- Study design
- RandomizedDouble-blind
Dose Escalation: Low Dose
hUC-MSC-Exo 2.5x10^10 particles
Dose Escalation: Mid Dose
hUC-MSC-Exo 5.0x10^10 particles
Dose Escalation: High Dose
hUC-MSC-Exo 1.0x10^11 particles
Expansion: Exosome Group
hUC-MSC-Exo at MTD
Expansion: Control Group
Placebo (Exosome mimetic)
03
Who it enrols
Adult patients (18-65) with autoimmune encephalitis (anti-NMDAR or anti-LGI1 positive) diagnosed within 3 months and mRS >= 2. Excludes patients with severe organ dysfunction, active infections (HBV, HCV, HIV, Syphilis), pregnancy, or prior stem cell therapy.
04
Endpoints
Primary
Dose-Limiting Toxicity events
Modified Rankin Scale
Secondary
Adverse Events and Serious Adverse Events
Modified Rankin Scale
Percentage of mRS 0-2
Percentage of mRS improvement >= 1
Clinical Assessment Scale in Autoimmune Encephalitis
Activities of Daily Living
Mini-Mental State Examination
Montreal Cognitive Assessment
Beyond the preview
Go deeper on NCT07131683.
Full results, competitive context and analysis are in the Gosset platform.
Competitive context
Available in the Gosset platform where reported.
Bring the full picture into focus.
See how Gosset can support your research on NCT07131683.