Evaluate the Safety and Tolerability of CE211NS21 in Patients With AQP4-IgG-positive NMOSD Relapse
NCT07595965 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 6
Last updated 2026-05-19
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
Conditions
- Neuromyelitis Optica Spectrum Disorder Relapse
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
Sponsors & Collaborators
-
Corestemchemon, Inc.
lead INDUSTRY
Principal Investigators
-
sungmin Kim, MD, PhD · Seoul University hospital
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 19 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-12-01
- Primary Completion
- 2027-12-30
- Completion
- 2028-12-30
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