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NOT YET RECRUITING
NCT07595965
PHASE1

Evaluate the Safety and Tolerability of CE211NS21 in Patients With AQP4-IgG-positive NMOSD Relapse

Sponsor: Corestemchemon, Inc.

View on ClinicalTrials.gov

Summary

To evaluate the safety and tolerability of allogeneic bone marrow-derived mesenchymal stem cells (CE211NS21) in patients with severe anti-aquaporin-4-immunoglobulin G positive neuromyelitis optica spectrum disorder (AQP4-IgG-positive NMOSD) relapse

Official title: A Phase I Clinical Trial to Evaluate the Safety and Tolerability of Allogeneic Bone Marrow-derived Mesenchymal Stem Cells in Patients With Severe Anti-aqua Porin-4-immunoglobulin G Positive Neuromyelitis Optica Spectrum Disorder Relapse

Key Details

Gender

All

Age Range

19 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

6

Start Date

2026-12-01

Completion Date

2028-12-30

Last Updated

2026-05-19

Healthy Volunteers

No

Interventions

BIOLOGICAL

CE211NS21

baseline (D0), 4-week point (Visit 3), and 16-week point (Visit 6) for intrathecal administration of CE211NS21, Step 1 dose : 1x10\^6 cells/kg Step 2 dose : 2x10\^6 cells/kg; The Duration of follow up study following the administration of CE211NS21 is 5 years