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Intranasal Human Adipose-Derived Stem Cell Exosomes for Acute Ischemic Stroke Treatment

Study Aim

This study aims to evaluate the safety and tolerability of ADSC-exo Nasal Spray in individuals with Acute Ischemic Stroke, by monitoring changes in immunoglobulin levels, pulmonary function, and nasal mucosa, as well as any treatment-emergent adverse events.

What is being tested

Human Adipose-Derived Stem Cell Exosomes

+ Placebo

BiologicalOther

Who is being recruted

Ischemic Stroke+5

+ Brain Diseases

+ Cardiovascular Diseases

From 18 to 80 Years

+23 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Placebo-ControlledPhase 1 & 2

Interventional

Study Start: January 2026

See protocol details

Summary

Principal SponsorShanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Study ContactXia Liu, M.D., Ph.D.More contacts

Last updated: February 11, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: January 31, 2026

Actual date on which the first participant was enrolled.

This clinical trial focuses on the safety and effectiveness of a new treatment called Human Adipose-Derived Stem Cell Exosomes (ADSC-exo, STX11102) for individuals who have experienced a mild to moderate acute ischemic stroke. The treatment is administered via a nasal spray and has shown promising results in animal models, demonstrating the ability to reach the brain, reduce inflammation, decrease damage, and improve recovery. The goal of this study is to evaluate if these benefits translate to humans, potentially offering a new approach to stroke treatment. The study is divided into two parts. The first part involves a small group of patients receiving a single dose of the nasal spray, with the dose increasing gradually to assess safety and tolerability. The second part is larger, with patients receiving multiple doses of the nasal spray or a placebo (a substance with no therapeutic effect) for 14 days. The effects of the treatment will be measured through various tests, including neurological assessments, blood tests, and brain scans. The study will evaluate changes in stroke symptoms, daily living activities, and brain lesion volume, as well as any side effects or adverse events related to the treatment.

Official TitleClinical Study on the Safety and Efficacy of Human Adipose-Derived Stem Cell Exosomes in the Treatment of Acute Ischemic Stroke

NCT07398612

Principal SponsorShanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Study ContactXia Liu, M.D., Ph.D.More contacts

Last updated: February 11, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

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

Design Details

60 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 80 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Ischemic StrokeBrain DiseasesCardiovascular DiseasesCentral Nervous System DiseasesCerebrovascular DisordersNervous System DiseasesVascular DiseasesStroke

Criteria

7 inclusion criteria required to participate

Patients with acute ischemic stroke within 72 hours of symptom onset

Age 18-80 years, male or female

Internal carotid artery system stroke

For the single-dose study: mild stroke patients (NIHSS score 1-4, inclusive of 1 and 4)

Show More Criteria

16 exclusion criteria prevent from participating

Patients with malignant tumors.

Patients who have participated in another clinical trial within the past 3 months.

Patients allergic to the product or with severe allergic constitution.

Presence of severe infection or fever; patients with severe respiratory diseases.

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

7 intervention groups are designated in this study

28.571% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental

This is a double-blind, multiple-dose treatment arm in the dose-expansion phase (Part 2). Sixteen (16) subjects with acute ischemic stroke will receive Human Adipose-Derived Stem Cell Exosomes (ADSC-exo) Nasal Spray at a high concentration (designated as Y ×10\^9 particles per mL, to be determined based on SAD results), administered intranasally once daily (QD) for 14 consecutive days. This is administered in addition to standard of care (SOC). This arm is compared to a placebo control arm within the same high-dose group. Enrollment into this high-dose group is contingent upon a safety review of the low-dose group.

Group II

Experimental

This is a double-blind, multiple-dose treatment arm in the dose-expansion phase (Part 2). Sixteen (16) subjects with acute ischemic stroke will receive Human Adipose-Derived Stem Cell Exosomes (ADSC-exo) Nasal Spray at a low concentration (designated as X ×10\^9 particles per mL, to be determined based on SAD results), administered intranasally once daily (QD) for 14 consecutive days. This is administered in addition to standard of care (SOC). This arm is compared to a placebo control arm within the same low-dose group.

Group III

Experimental

This is an open-label, single-dose cohort in the dose-escalation phase (Part 1). Four (4) subjects with acute ischemic stroke will receive a single dose of Human Adipose-Derived Stem Cell Exosomes (ADSC-exo) Nasal Spray at a concentration of 2×10\^9 particles per mL (total volume 1 mL), administered intranasally once.

Group IV

Experimental

This is an open-label, single-dose cohort in the dose-escalation phase (Part 1). Four (4) subjects with acute ischemic stroke will receive a single dose of Human Adipose-Derived Stem Cell Exosomes (ADSC-exo) Nasal Spray at a concentration of 4×10\^9 particles per mL (total volume 1 mL), administered intranasally once.

Group 5

Experimental

This is an open-label, single-dose cohort in the dose-escalation phase (Part 1). Four (4) subjects with acute ischemic stroke will receive a single dose of Human Adipose-Derived Stem Cell Exosomes (ADSC-exo) Nasal Spray at a concentration of 8×10\^9 particles per mL (total volume 1 mL), administered intranasally once.

Group 6

Placebo

This is a double-blind, multiple-dose control arm in the dose-expansion phase (Part 2). Eight (8) subjects with acute ischemic stroke will receive a matching Placebo Nasal Spray (0.9% physiological saline), administered intranasally once daily (QD) for 14 consecutive days. This is administered in addition to standard of care (SOC). This arm serves as the comparator for the active high-dose ADSC-exo arm.

Group 7

Placebo

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

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