The Safety and Efficacy of NouvSoma001 in Ischemic Stroke

NCT06612710 | Recruiting Phase 1

• 1 other identifier: NouvSoma001inIS
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 1

Brief 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 ischemic stroke.

Conditions

Ischemic Stroke

Keywords

Ischemic Stroke; extracellular vesicles

Outcome Measures

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

  Up to 6 month after treatment initiation

Secondary Outcomes (16)

• The incidence and severity of all adverse events (AE) and serious adverse events (SAE)

  Up to 18 month after treatment initiation

• Magnetic Resonance Imaging(MRI) at month 3、6 compared with baseline and control group.

  Up to 6 month after treatment initiation

• The National Institutes of Health Stroke Scale, NIHSS

  Up to 6 month after treatment initiation

• The Modified Rankin Scale (mRS)

  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.

  Up to 6 month after treatment initiation

Study Arms (2)

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.

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.

Drug: a placebo of extracellular vesicles derived from human induced neural stem cell for intravenous injection

Interventions

extracellular vesicles derived from human induced neural stem cell for intravenous injection DRUG

extracellular vesicles derived from human induced neural stem cell for intravenous injection（4×10\^9 particles/kg）

Also known as: NouvSoma001

extracellular vesicles group

a placebo of extracellular vesicles derived from human induced neural stem cell for intravenous injection DRUG

extracellular vesicles placebo (4×10\^9 particles/kg)

Also known as: NouvSoma001placebo

extracellular vesicles placebo group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Wei Wang: lead
• iRegene Therapeutics Co., Ltd.: collaborator

Study Sites (1)

Tongji Hospital affiliated to Tongji Medical College of Huazhong University ofScience and Technology

Wuhan, Hubei, 430000, China

RECRUITING

Related Publications (3)

• 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.

  PMID: 37104115 RESULT

• Zhu 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.

  PMID: 35900437 RESULT

• Gao 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.

  PMID: 37311758 RESULT

MeSH Terms

Conditions

Ischemic Stroke

Interventions

Injections, Intravenous

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Administration, Intravenous; Drug Administration Routes; Drug Therapy; Therapeutics; Injections

Study Officials

• Wei Wang, MD

  Tongji Hospital

  PRINCIPAL INVESTIGATOR

• Daishi Tian, MD

  Tongji Hospital

  PRINCIPAL INVESTIGATOR

• Chuan Qin, MD

  Tongji Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chuan Qin, MD

CONTACT

86-27-83663337; qinchuan712@126.com

Chuan Qin, MD

CONTACT

86-27-83663332; chuanqin@tjh.tjmu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: September 22, 2024
• First Posted: September 25, 2024
• Study Start: November 30, 2025
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): November 30, 2027
• Last Updated: January 21, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)