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NOT YET RECRUITING

NCT07398612

PHASE1/PHASE2

Safety and Efficacy of Human Adipose-Derived Stem Cell Exosomes in Acute Ischemic Stroke

Sponsor: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

View on ClinicalTrials.gov

Summary

This is a Phase I/II, randomized, double-blind, placebo-controlled, single/multiple ascending dose clinical study (Investigator-Initiated Trial, IIT) evaluating the safety and efficacy of Human Adipose-Derived Stem Cell Exosomes (ADSC-exo, STX11102 Nasal Spray) in treating acute ischemic stroke (AIS). The study consists of two sequential parts: a Single-Ascending Dose (SAD) study and a Multiple-Ascending Dose (MAD) study. The SAD part will enroll 12 subjects with mild stroke (NIHSS 1-4). They will be sequentially enrolled into three dose cohorts (4 subjects each: 2×10⁹, 4×10⁹, and 8×10⁹ particles/mL) to receive a single nasal spray dose alongside standard care, with safety monitoring for 14 days. Dose escalation is contingent upon the safety review of the preceding cohort. Upon confirming safety, the study proceeds to the MAD part, which will enroll 48 subjects with moderate stroke (NIHSS 5-12). They will be randomized into two dose groups (Low and High Dose), each containing an active treatment arm and a placebo arm (saline) in a 2:1 ratio (16 active:8 placebo per group). Subjects will self-administer the nasal spray daily for 14 days, with follow-up until Day 90. The primary objective is to evaluate safety, with secondary objectives assessing efficacy via neurological function scales (NIHSS, mRS, BI) and infarct volume change on MRI.

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

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2026-01-31

Completion Date

2028-08-31

Last Updated

2026-02-10

Healthy Volunteers

Conditions

Acute Ischemic Stroke

Interventions

BIOLOGICAL

Human Adipose-Derived Stem Cell Exosomes

This intervention involves the use of allogeneic Human Adipose-Derived Stem Cell Exosomes (ADSC-exo), provided as a sterile nasal spray (STX11102).

OTHER

Placebo

This intervention serves as the placebo control. It is a sterile 0.9% sodium chloride (normal saline) solution formulated as a nasal spray

Inclusion Criteria: 1. Age 18-80 years, male or female 2. Patients with acute ischemic stroke within 72 hours of symptom onset 3. Internal carotid artery system stroke 4. For the single-dose study: mild stroke patients (NIHSS score 1-4, inclusive of 1 and 4) 5. For the multiple-dose study: moderate stroke patients (NIHSS score 5-12, inclusive of 5 and 12) 6. Pre-stroke mRS score ≤ 1 7. Subjects or their guardians voluntarily sign the informed consent form Exclusion Criteria: 1. Moderate or severe stroke (NIHSS score \> 12). 2. Lacunar infarction, brainstem or cerebellar infarction (confirmed by DWI-MRI). 3. Requirement for endovascular interventional treatment for the current episode. 4. Intracranial hemorrhagic diseases (including parenchymal, intraventricular, subarachnoid hemorrhage, etc.). 5. Patients with malignant tumors. 6. Patients with severe traumatic brain injury. 7. Patients with primary or secondary immunodeficiency diseases or requiring immunosuppressant medication. 8. Serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) exceeding 3 times the upper limit of normal. 9. Chronic kidney disease or current serum creatinine exceeding 1.5 times the upper limit of normal or estimated glomerular filtration rate (eGFR) \< 60 mL/min/1.73m². 10. Presence of severe infection or fever; patients with severe respiratory diseases. 11. Positive for hepatitis B virus surface antigen (HBsAg); or positive for hepatitis B core antibody (HBcAb) with positive HBV-DNA; or positive for hepatitis C virus antibody (HCVAb), Treponema pallidum antibody (TPAb/RPR), or human immunodeficiency virus antibody (HIV). 12. Patients who are pregnant or lactating at screening, or wish to become pregnant during the study period. Patients allergic to the product 13. Patients allergic to the product or with severe allergic constitution. 14. Patients deemed unsuitable for participation by the investigator, or for whom participation may pose a greater risk. 15. Patients who have participated in another clinical trial within the past 3 months. 16. Patients with prior use of exosomes.