The Safety and Efficacy of NouvSoma001 in Neuromyelitis Optica Spectrum Disorders
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-65
SponsorTongji Hospital
About this trial
This is a single-center, randomized, open-label, placebo-controlled, dose-escalation trial. The objective of this research is to evaluate the safety, tolerability, and efficacy of intrathecal administration of human-induced neural stem cell-derived extracellular vesicles (NouvSoma001) for the treatment of neuromyelitis optica spectrum disorders.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients must meet the 2015 International Consensus Diagnostic Criteria for Neuromyelitis Optica Spectrum Disorder (NMOSD) and test positive for AQP4 antibodies.
Symptom onset occurred within 7 days prior to enrollment, with associated severe pain, lower limb motor dysfunction, or urinary/bowel impairment.
Males or Females aged between 18 and 65 years.
The Expanded Disability Status Scale (EDSS) score prior to the current disease episode is ≤ 4.
Disqualifiers
Any contraindications to lumbar puncture.
Pregnant or breastfeeding women, and patients with plans to conceive during the trial.
Patients with a known history of allergies to human-derived biological products or those with an allergic predisposition.
Patients who have undergone hematopoietic stem cell transplantation or lymphatic irradiation before enrollment.
Trial design
Design model
Sequential
Treatments tested in this trial
Extracellular vesicles derived from human-induced neural stem cells for intrathecal injection
DrugExtracellular vesicles derived from human-induced neural stem cells for intrathecal injection
A placebo of extracellular vesicles derived from human-induced neural stem cells for intrathecal injection
DrugA placebo of extracellular vesicles derived from human-induced neural stem cells for intrathecal injection
Treatment groups
69 Participants
are divided into 2 treatment groupsGroup A: Extracellular vesicles groupExperimental treatment 1 intervention
Group B: Extracellular vesicles placebo groupPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
The incidence and severity of all adverse events (AE) and serious adverse events (SAE)
The assessment of adverse events and serious adverse events
Time frame
Up to 6 month after treatment initiationSecondary outcomes
1
The incidence and severity of all adverse events (AE) and serious adverse events (SAE)
The assessment of adverse events and serious adverse events
Time frame
Up to 18 month after treatment initiation2
Magnetic Resonance Imaging (MRI) scans of the brain and spinal cord at month 1 and month 6
Time frame
Up to 6 month after treatment initiation3
The score of Visual analogue scale（VAS）
Time frame
Up to 6 month after treatment initiation4
Brief Pain Inventory - Short form (BPI-SF)
Time frame
Up to 6 month after treatment initiationSponsors and contacts
Click on the lead sponsor to view all of their trials.
Tongji Hospital
Lead sponsor
iRegene Therapeutics Co., Ltd.
Collaborator
Source ClinicalTrials.gov