Actively Recruiting
Led by Tongji Hospital · Updated on 2026-01-21
69
Participants Needed
1
Research Sites
52 weeks
Total Duration
T
Tongji Hospital
Lead Sponsor
I
iRegene Therapeutics Co., Ltd.
Collaborating Sponsor
Researchers are evaluating the safety, tolerability, and effectiveness of NouvSoma001, a treatment made from human-induced neural stem cell-derived extracellular vesicles, for patients with neuromyelitis optica spectrum disorders (NMOSD). This trial is a single-center, randomized, open-label, placebo-controlled, dose-escalation study designed to explore different dosing levels and extend treatment based on initial findings. The study aims to better understand how this treatment may help people with NMOSD, a condition diagnosed by specific criteria and associated with severe symptoms affecting movement, pain, and bladder or bowel function. The trial consists of two parts: Part 1 involves escalating doses of NouvSoma001 given by intrathecal injection, starting with 5 × 10^9 particles and increasing to 3 × 10^10 particles if no significant toxicities occur. Participants are grouped in cohorts of three to nine, with dose adjustments based on safety findings within 2 weeks after the first dose. Part 2 involves 60 participants randomized in a 2:1 ratio to receive either the selected dose of NouvSoma001 or a placebo by the same intrathecal injection method. Both groups receive their assigned treatment once in a single day. Participants will undergo various evaluations including monitoring for adverse events up to six months after treatment, imaging scans of the brain and spinal cord, and assessments of pain, disability, visual function, mental health, quality of life, and several biological markers in blood and cerebrospinal fluid. These measures will be compared to baseline and placebo groups to assess changes. Safety and tolerability will be closely followed, with additional assessments continuing up to 18 months. Overall, participation involves medical evaluations, imaging, laboratory tests, and questionnaires over a period extending beyond six months.
CONDITIONS
The Safety and Efficacy of NouvSoma001 in Neuromyelitis Optica Spectrum Disorders
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Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants receive a single intrathecal injection of extracellular vesicles or placebo based on their assigned cohort and dose level.
1 treatment visit (in-person)
Duration - Up to 6 months
Participants are monitored for safety and efficacy through clinical assessments, imaging, and laboratory tests over 6 months after treatment.
Visits at month 1, 3, and 6 for assessments including MRI, visual function tests, and blood and cerebrospinal fluid sampling
Total: 1 location
1
Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology
Wuhan, Hubei, China, 430000
Actively Recruiting
C
Chuan Qin, MD
C
Chuan Qin, MD
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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