The Safety and Efficacy of NouvSoma001 in Ischemic Stroke

January 18, 2026 updated by: Wei Wang

An Open-label Exploratory Clinical Trial to Assess the Safety and Efficacy of NouvSoma001 in the Treatment of Ischemic Stroke

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 preliminary efficacy of intravenous administration of human-induced neural stem cell-derived extracellular vesicles (NouvSoma001) in the treatment of ischemic stroke.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This is a single-center, randomized, open-label, placebo-controlled, dose-escalation trial. This study will consist of 2 parts, with Part 1 being a dose-escalation study and Part 2 being a dose-extension study based on the results of Part 1. Part 1 will follow a traditional 3+3 dose-escalation design, enrolling a total of 9 subjects. Cohort 1: receive 4×10^9 particles/kg, Cohort 2: receive 8×10^9 particles/kg, and Cohort 3: receive 1.6×10^10 particles/kg. If no dose-limiting toxicities (DLT) are observed within 2 weeks after the initial administration, a new cohort will be enrolled at the next higher dose level. If DLTs are observed in 1 participant, another 2 participants will be treated at the same dose level. Dose escalation will cease if DLTs are observed in more than 33% of the participants. In Part 2, the remaining 60 participants will be randomized in a 2:1 ratio to the treatment and placebo groups, with the dose level determined by the Data Safety Monitoring Board based on the results of Part 1.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
69

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • China
    • Hubei
      • Wuhan, Hubei, China, 430000
        • Recruiting
        • Tongji Hospital affiliated to Tongji Medical College of Huazhong University ofScience and Technology
        • Principal Investigator:
          • Wei Wang, MD
        • Contact:
        • Contact:
        • Principal Investigator:
          • Daishi Tian, MD
        • Principal Investigator:
          • Chuan Qin, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. The age of the recruiters ranged from 18 to 75 years.
  2. Clinical diagnosis of ischemic stroke, the time of stroke onset is known, and the onset occurred no more than 7 days before enrollment.
  3. Magnetic resonance imaging (MRI) or computed tomography (CT) findings consistent with ischemic stroke.
  4. At the time of enrollment, the NIHSS score is between 6 and 20; additionally, there is at least one limb with muscle strength ≤ Grade 3.
  5. Patients who have the mental capacity to understand and participate in the study.
  6. Informed consent was obtained from patients or their legal representatives.

Exclusion Criteria:

  1. CT indicates intracranial hemorrhage, including hemorrhagic stroke, epidural hematoma, subdural hematoma, intraventricular hemorrhage, subarachnoid hemorrhage, or hemorrhagic transformation.
  2. Patients with Alzheimer's disease, Parkinson's syndrome, or other neurodegenerative disorders.
  3. Evidence of brain tumors, epilepsy, or a history of traumatic brain injury.
  4. Presence of non-vascular diseases causing white matter lesions, such as carbon monoxide poisoning, multiple sclerosis, or adrenoleukodystrophy.
  5. Rapid spontaneous neurological improvement during the screening period, defined as a reduction of NIHSS score by ≥ 8 points from symptom onset to the first administration.
  6. Persistent systemic infection, severe local infection, or ongoing use of immunosuppressants.
  7. Patients with malignant diseases or an expected survival of less than 5 years.
  8. Significant hearing or vision impairments, language disorders, or claustrophobia that would hinder cooperation with neuropsychological assessments and MRI examinations.
  9. Contraindications to MRI.
  10. Patients unable to comply with follow-up requirements during the study.
  11. Severe liver, renal, cardiac, or pulmonary insufficiency, hematologic disorders, or malignant tumors (Liver insufficiency is defined as ALT or AST levels greater than 1.5 times the upper normal limit; renal insufficiency is defined as serum creatinine levels greater than 1.5 times the upper normal limit).
  12. Patients with alcohol addiction or those testing positive for drug abuse.
  13. Patients with a history of severe allergies or known allergy to human biological products.
  14. Pregnant or breastfeeding women, and those planning to conceive during the trial period.
  15. Participation in other clinical trials within the past 3 months.
  16. Patients considered unsuitable for participation by the investigator.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: extracellular vesicles group
Patients in this arm will be given extracellular vesicles derived from human-induced neural stem cells for intravenous injection once a day for 7 days.
Drug: extracellular vesicles derived from human induced neural stem cell for intravenous injection
extracellular vesicles derived from human induced neural stem cell for intravenous injection（4×10^9 particles/kg）
Other Names:
  • NouvSoma001
Placebo Comparator: extracellular vesicles placebo group
Patients in this arm will be given a placebo of extracellular vesicles derived from human-induced neural stem cells for intravenous injection once a day for 7 days.
Drug: a placebo of extracellular vesicles derived from human induced neural stem cell for intravenous injection
extracellular vesicles placebo (4×10^9 particles/kg)
Other Names:
  • NouvSoma001placebo

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
The incidence and severity of all adverse events (AE) and serious adverse events (SAE)
Time Frame: Up to 6 month after treatment initiation
The assessment of adverse events and serious adverse events
Up to 6 month after treatment initiation

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The incidence and severity of all adverse events (AE) and serious adverse events (SAE)
Time Frame: Up to 18 month after treatment initiation
The assessment of adverse events and serious adverse events
Up to 18 month after treatment initiation
Magnetic Resonance Imaging(MRI) at month 3、6 compared with baseline and control group.
Time Frame: Up to 6 month after treatment initiation
Up to 6 month after treatment initiation
The National Institutes of Health Stroke Scale, NIHSS
Time Frame: Up to 6 month after treatment initiation
To assess NIHSS of subjects at month 1、3、6 after treatment initiation
Up to 6 month after treatment initiation
The Modified Rankin Scale (mRS)
Time Frame: Up to 6 month after treatment initiation
To assess mRS of subjects within month 1、3、6 after treatment initiation
Up to 6 month after treatment initiation
The score of Mini-mental State Examination (MMSE) at month 1、3、6 compared with baseline and control group.
Time Frame: Up to 6 month after treatment initiation
The score of MMSE ranges from 0 to 30, and 30 represents the best.
Up to 6 month after treatment initiation
The score of Montreal cognitive assessment scale (MoCA) at month 1、3、6 compared with baseline and control group.
Time Frame: Up to 6 month after treatment initiation
The score of MoCA ranges from 0 to 30, and 30 represents the best.
Up to 6 month after treatment initiation
The score of Barthel Index for activities of daily living (ADL) at month 1、3、6 compared with baseline and control group.
Time Frame: Up to 6 month after treatment initiation
The score of ADL ranges from 0 to 100, and 100 represents the best.
Up to 6 month after treatment initiation
The score of Hamilton Depression Scale at month 1、3、6 compared with baseline and control group.
Time Frame: Up to 6 month after treatment initiation
The score of Hamilton Depression Scale ranges from 0 to 81, and 81 represents the worst.
Up to 6 month after treatment initiation
The score of Hamilton Anxiety Scale at month 1、3、6 compared with baseline and control group.
Time Frame: Up to 6 month after treatment initiation
The score of Hamilton Anxiety Scale ranges from 0 to 56, and 56 represents the worst.
Up to 6 month after treatment initiation
The score of Clock Drawing Test at month 1、3、6 compared with baseline and control group
Time Frame: Up to 6 month after treatment initiation
Up to 6 month after treatment initiation
The value of Quality of Life (EQ-5D-5L) at month 1、3、6 compared with baseline and control group.
Time Frame: Up to 6 month after treatment initiation
Up to 6 month after treatment initiation
The score of Alzheimer's disease assessment scale-cognitive section (ADAS-cog) at month 1、3、6 compared with baseline and control group.
Time Frame: Up to 6 month after treatment initiation
The score of Alzheimer's disease assessment scale-cognitive section ranges from 0 to 70, and 70 represents the worst.
Up to 6 month after treatment initiation
The score of Clinical Dementia Rating (CDR) at month 1、3、6 compared with baseline and control group.
Time Frame: Up to 6 month after treatment initiation
Up to 6 month after treatment initiation
The score of Hopkins verbal learning test（HVLT）at month 1、3、6 compared with baseline and control group.
Time Frame: Up to 6 month after treatment initiation
Up to 6 month after treatment initiation
The incidence of Columbia-Suicide Severity Rating Scale (C-SSRS) events at month 1、3、6 compared with baseline and control group.
Time Frame: Up to 6 month after treatment initiation
Up to 6 month after treatment initiation
The value of Nfl and GFAP in serum at month 1、3、6 compared with baseline and control group.
Time Frame: Up to 6 month after treatment initiation
Up to 6 month after treatment initiation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Wei Wang

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
iRegene Therapeutics Co., Ltd.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Wei Wang, MD, Tongji Hospital
  • Principal Investigator: Daishi Tian, MD, Tongji Hospital
  • Principal Investigator: Chuan Qin, MD, Tongji Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 30, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 30, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 30, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 22, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 24, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 25, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 21, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 18, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NouvSoma001inIS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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