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Tests treatment safety and results for Neuromyelitis Optica Spectrum Disorders
Official title The Safety and Efficacy of NouvSoma001 in Neuromyelitis Optica Spectrum Disorders
ClinicalTrials.gov ID: NCT06620809
What this study is testing
What is Extracellular vesicles derived from human-induced neural stem cells for intrathecal injection?
Extracellular vesicles derived from human-induced neural stem cells for intrathecal injection is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for neuromyelitis optica spectrum disorders.
Also referred to as NouvSoma001.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- Patients must meet the 2015 International Consensus Diagnostic Criteria for Neuromyelitis Optica Spectrum Disorder (NMOSD) and test positive for AQP4...
- 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.
- Female participants of childbearing potential must present a negative pregnancy test at screening and agree to use effective contraception throughout...
You likely can't join if
- Abnormal laboratory indicators of the people need to be excluded, including, but not limited to, the following indicators: White Blood Cell Count \...
- 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.
- Patients who have participated in any other clinical trial within the last 3 months.
See the full eligibility criteria
- 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.
- Female participants of childbearing potential must present a negative pregnancy test at screening and agree to use effective contraception throughout the study period.
- Informed consent must be obtained from the patient or their legal representative, with a signed consent form must be provided.
- Abnormal laboratory indicators of the people need to be excluded, including, but not limited to, the following indicators: White Blood Cell Count \ 1.5\ ULN Total Bilirubin \>1.5\ ULN AST (GOT) \>3\ ULN ALT (GPT) \>3\...
- 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.
- Patients who have participated in any other clinical trial within the last 3 months.
- Patients with severe comorbidities, including immunodeficiency or coagulation disorders.
- Patients with active suicidal ideation within 6 months before screening or have a history of suicide attempts within 3 years before screening.
- Patients with severe psychiatric symptoms that prevent clinical cooperation.
- Patients with positive for alcohol addiction or drug abuse.
- Patients with malignant tumors.
- Patients who have experienced any of the following events within 12 weeks before enrollment: myocardial infarction, unstable ischemic heart disease, stroke, or New York Heart Association Class IV heart failure.
- Patients with persistent systemic infections and severe local infections.
- Patients unable to undergo magnetic resonance imaging during the trial.
- Patients deemed unsuitable for participation by the investigator.
The study team makes the final eligibility decision.
Where it's taking place
- Wuhan, Hubei, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Wuhan, Hubei, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.