Ischemic StrokePhase 1NCT06612710
The Safety and Efficacy of NouvSoma001 in Ischemic Stroke
A Phase 1 study testing extracellular vesicles derived from human induced neural stem cell for intravenous injection in people with Ischemic Stroke, run by Wei Wang at 1 site in China.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Ischemic Stroke
- What is being tested?
- extracellular vesicles derived from human induced neural stem cell for intravenous injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 69 participants
- Where
- 1 siteChina
- Study dates
- 30 Nov 2025to 30 Nov 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The age of the recruiters ranged from 18 to 75 years.
- Clinical diagnosis of ischemic stroke, the time of stroke onset is known, and the onset occurred no more than 7 days before enrollment.
- Magnetic resonance imaging (MRI) or computed tomography (CT) findings consistent with ischemic stroke.
- 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.
- Patients who have the mental capacity to understand and participate in the study.
- Informed consent was obtained from patients or their legal representatives.
Who cannot join
- CT indicates intracranial hemorrhage, including hemorrhagic stroke, epidural hematoma, subdural hematoma, intraventricular hemorrhage, subarachnoid hemorrhage, or hemorrhagic transformation.
- Patients with Alzheimer's disease, Parkinson's syndrome, or other neurodegenerative disorders.
- Evidence of brain tumors, epilepsy, or a history of traumatic brain injury.
- Presence of non-vascular diseases causing white matter lesions, such as carbon monoxide poisoning, multiple sclerosis, or adrenoleukodystrophy.
- 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.
- Persistent systemic infection, severe local infection, or ongoing use of immunosuppressants.
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- Patients with malignant diseases or an expected survival of less than 5 years.
- Significant hearing or vision impairments, language disorders, or claustrophobia that would hinder cooperation with neuropsychological assessments and MRI examinations.
- Contraindications to MRI.
- Patients unable to comply with follow-up requirements during the study.
- 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).
- Patients with alcohol addiction or those testing positive for drug abuse.
- Patients with a history of severe allergies or known allergy to human biological products.
- Pregnant or breastfeeding women, and those planning to conceive during the trial period.
- Participation in other clinical trials within the past 3 months.
- Patients considered unsuitable for participation by the investigator.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Tongji Hospital affiliated to Tongji Medical College of Huazhong University ofScience and Technology
Wuhan, Hubei, 430000
Chuan Qiun, 86-27-83663337, qinchuan712@126.com
Chuan Qin, 86-27-83663332, chuanqin@tjh.tjmu.edu.cn
About this study
Official title: 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.
Read the 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.
- Conditions
- Ischemic Stroke
- Being tested
- extracellular vesicles derived from human induced neural stem cell for intravenous injection, a placebo of extracellular vesicles derived from human induced neural stem cell for intravenous injection
- Keywords
- Ischemic Stroke, extracellular vesicles
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
extracellular vesicles derived from human induced neural stem cell for intravenous injectionDrug
Also called NouvSoma001
extracellular vesicles derived from human induced neural stem cell for intravenous injection（4×10^9 particles/kg）
a placebo of extracellular vesicles derived from human induced neural stem cell for intravenous injectionDrug
Also called NouvSoma001placebo
extracellular vesicles placebo (4×10^9 particles/kg)
| Study group | Role | What they receive |
|---|---|---|
| extracellular vesicles group | Experimental | 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. Receives: Drug: extracellular vesicles derived from human induced neural stem cell for intravenous injection |
| extracellular vesicles placebo group | Placebo comparator | 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. Receives: Drug: a placebo of extracellular vesicles derived from human induced neural stem cell for intravenous injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence and severity of all adverse events (AE) and serious adverse events (SAE)
The assessment of adverse events and serious adverse events
Measured: Up to 6 month after treatment initiation
Secondary outcomes (16)
The incidence and severity of all adverse events (AE) and serious adverse events (SAE)
The assessment of adverse events and serious adverse events
Measured: Up to 18 month after treatment initiation
Magnetic Resonance Imaging(MRI) at month 3、6 compared with baseline and control group.
Measured: Up to 6 month after treatment initiation
The National Institutes of Health Stroke Scale, NIHSS
To assess NIHSS of subjects at month 1、3、6 after treatment initiation
Measured: Up to 6 month after treatment initiation
The Modified Rankin Scale (mRS)
To assess mRS of subjects within month 1、3、6 after treatment initiation
Measured: 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.
The score of MMSE ranges from 0 to 30, and 30 represents the best.
Measured: 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.
The score of MoCA ranges from 0 to 30, and 30 represents the best.
Measured: 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.
The score of ADL ranges from 0 to 100, and 100 represents the best.
Measured: Up to 6 month after treatment initiation
The score of Hamilton Depression Scale at month 1、3、6 compared with baseline and control group.
The score of Hamilton Depression Scale ranges from 0 to 81, and 81 represents the worst.
Measured: Up to 6 month after treatment initiation
The score of Hamilton Anxiety Scale at month 1、3、6 compared with baseline and control group.
The score of Hamilton Anxiety Scale ranges from 0 to 56, and 56 represents the worst.
Measured: Up to 6 month after treatment initiation
The score of Clock Drawing Test at month 1、3、6 compared with baseline and control group
Measured: 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.
Measured: 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.
The score of Alzheimer's disease assessment scale-cognitive section ranges from 0 to 70, and 70 represents the worst.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to 6 month after treatment initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2024
- Study start30 Nov 2025
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Ischemic StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 69 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wei Wang
- Sponsor type
- University, hospital or other
- Collaborators
- iRegene Therapeutics Co., Ltd.
- Responsible party
- Sponsor-investigator, Wei Wang, Tongji Hospital
- Investigators
- Wei Wang, MD, Principal investigator, Tongji HospitalDaishi Tian, MD, Principal investigator, Tongji HospitalChuan Qin, MD, Principal investigator, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06612710
- Sponsor's protocol ID
- NouvSoma001inIS
- Status last verified
- Jan 2026
- First submitted
- 22 Sep 2024
- Last updated
- 21 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zhang R, Mao W, Niu L, Bao W, Wang Y, Wang Y, Zhu Y, Yang Z, Chen J, Dong J, Cai M, Yuan Z, Song H, Li G, Zhang M, Xiong N, Wei J, Dong Z. NSC-derived exosomes enhance therapeutic effects of NSC transplantation on cerebral ischemia in mice. Elife. 2023 Apr 27;12:e84493. doi: 10.7554/eLife.84493.
PubMed 37104115Zhu ZH, Jia F, Ahmed W, Zhang GL, Wang H, Lin CQ, Chen WH, Chen LK. Neural stem cell-derived exosome as a nano-sized carrier for BDNF delivery to a rat model of ischemic stroke. Neural Regen Res. 2023 Feb;18(2):404-409. doi: 10.4103/1673-5374.346466.
PubMed 35900437Gao G, Li C, Ma Y, Liang Z, Li Y, Li X, Fu S, Wang Y, Xia X, Zheng JC. Neural stem cell-derived extracellular vesicles mitigate Alzheimer's disease-like phenotypes in a preclinical mouse model. Signal Transduct Target Ther. 2023 Jun 14;8(1):228. doi: 10.1038/s41392-023-01436-1. No abstract available.
PubMed 37311758
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label Exploratory Clinical Trial to Assess the Safety and Efficacy of NouvSoma001 in the Treatment of Ischemic Stroke
- ClinicalTrials.gov ID
- NCT06612710
- Acronym / sponsor ID
- NouvSoma001inIS
- Conditions
- Ischemic Stroke
- Keywords
- Ischemic Stroke, extracellular vesicles
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 69 participants (estimated)
- Lead sponsor
- Wei WangUniversity, hospital or other
- Collaborators
- iRegene Therapeutics Co., Ltd.
- Study start
- 30 Nov 2025 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Nov 2027 (estimated)
- First posted
- 25 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| extracellular vesicles group | Experimental | Drug: extracellular vesicles derived from human induced neural stem cell for intravenous injectionPatients in this arm will be given extracellular vesicles derived from human-induced neural stem cells for intravenous injection once a day for 7 days. |
| extracellular vesicles placebo group | Placebo comparator | Drug: a placebo of extracellular vesicles derived from human induced neural stem cell for intravenous injectionPatients 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- The age of the recruiters ranged from 18 to 75 years.
- Clinical diagnosis of ischemic stroke, the time of stroke onset is known, and the onset occurred no more than 7 days before enrollment.
- Magnetic resonance imaging (MRI) or computed tomography (CT) findings consistent with ischemic stroke.
- 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.
- Patients who have the mental capacity to understand and participate in the study.
Key exclusion criteria (16 listed)
- CT indicates intracranial hemorrhage, including hemorrhagic stroke, epidural hematoma, subdural hematoma, intraventricular hemorrhage, subarachnoid hemorrhage, or hemorrhagic transformation.
- Patients with Alzheimer's disease, Parkinson's syndrome, or other neurodegenerative disorders.
- Evidence of brain tumors, epilepsy, or a history of traumatic brain injury.
- Presence of non-vascular diseases causing white matter lesions, such as carbon monoxide poisoning, multiple sclerosis, or adrenoleukodystrophy.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| extracellular vesicles derived from human induced neural stem cell for intravenous injectionAlso: NouvSoma001extracellular vesicles derived from human induced neural stem cell for intravenous injection（4×10^9 particles/kg） | Drug | extracellular vesicles group |
| a placebo of extracellular vesicles derived from human induced neural stem cell for intravenous injectionAlso: NouvSoma001placeboextracellular vesicles placebo (4×10^9 particles/kg) | Drug | extracellular vesicles placebo group |
Primary outcome
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
16 secondary outcomes
The incidence and severity of all adverse events (AE) and serious adverse events (SAE)
Time frame: 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
The National Institutes of Health Stroke Scale, NIHSS
Time frame: Up to 6 month after treatment initiation
The Modified Rankin Scale (mRS)
Time frame: 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 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 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 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 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 Clock Drawing Test at month 1、3、6 compared with baseline and control group
Time frame: 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
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 Clinical Dementia Rating (CDR) at month 1、3、6 compared with baseline and control group.
Time frame: 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
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2026.
- Results publication: PubMed 37104115Zhang R, Mao W, Niu L, Bao W, Wang Y, Wang Y, Zhu Y, Yang Z, Chen J, Dong J, Cai M, Yuan Z, Song H, Li G, Zhang M, Xiong N, Wei J, Dong Z. NSC-derived exosomes enhance therapeutic effects of NSC transplantation on cerebral ischemia in mice. Elife. 2023 Apr 27;12:e84493. doi: 10.7554/eLife.84493.
- Results publication: PubMed 35900437Zhu ZH, Jia F, Ahmed W, Zhang GL, Wang H, Lin CQ, Chen WH, Chen LK. Neural stem cell-derived exosome as a nano-sized carrier for BDNF delivery to a rat model of ischemic stroke. Neural Regen Res. 2023 Feb;18(2):404-409. doi: 10.4103/1673-5374.346466.
- Results publication: PubMed 37311758Gao G, Li C, Ma Y, Liang Z, Li Y, Li X, Fu S, Wang Y, Xia X, Zheng JC. Neural stem cell-derived extracellular vesicles mitigate Alzheimer's disease-like phenotypes in a preclinical mouse model. Signal Transduct Target Ther. 2023 Jun 14;8(1):228. doi: 10.1038/s41392-023-01436-1. No abstract available.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Wei Wang, MD principal investigator
Tongji Hospital
Daishi Tian, MD principal investigator
Tongji Hospital
Chuan Qin, MD principal investigator
Tongji Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing extracellular vesicles derived from human induced neural stem cell for intravenous injection in people with Ischemic Stroke, run by Wei Wang at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chuan Qin, MD (86-27-83663337, qinchuan712@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence and severity of all adverse events (AE) and serious adverse events (SAE) (time frame: Up to 6 month after treatment initiation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06612710, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2026; AzTrials last refreshed its copy on 8 Nov 2026.