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NCT07398612Not yet recruitingPhase 1/2

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

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

Source: ClinicalTrials.gov · Last updated 10 Feb 2026

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Phase (registry)
Phase 1/2
Study type
Interventional
Enrollment
60 (estimated)
First submitted
30 Dec 2025
Start date
31 Jan 2026
Primary completion date
31 May 2028
Lead sponsor
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Diseases
Stroke
NCT number
NCT07398612

What you commit to

  • Study type: Interventional · Phase 1/2
  • Planned participants: 60
  • From 31 Jan 2026 to the primary completion date, 31 May 2028
  • No sites listed in no country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Patients with prior use of exosomes.

Other illness

  • Moderate or severe stroke (NIHSS score \> 12).
  • Intracranial hemorrhagic diseases (including parenchymal, intraventricular, subarachnoid hemorrhage, etc.).
  • Patients with malignant tumors.
  • Patients with primary or secondary immunodeficiency diseases or requiring immunosuppressant medication.
  • Presence of severe infection or fever; patients with severe respiratory diseases.
  • 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).
  • Patients who are pregnant or lactating at screening, or wish to become pregnant during the study period. Patients allergic to the product
  • Patients allergic to the product or with severe allergic constitution.

Lab values

  • Serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) exceeding 3 times the upper limit of normal.
  • 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.

Other

  • Lacunar infarction, brainstem or cerebellar infarction (confirmed by DWI-MRI).
  • Requirement for endovascular interventional treatment for the current episode.
  • Patients with severe traumatic brain injury.
  • Patients deemed unsuitable for participation by the investigator, or for whom participation may pose a greater risk.
  • Patients who have participated in another clinical trial within the past 3 months.

Who the study is looking for

  • Age 18-80 years, male or female
  • Patients with acute ischemic stroke within 72 hours of symptom onset
  • Internal carotid artery system stroke
  • For the single-dose study: mild stroke patients (NIHSS score 1-4, inclusive of 1 and 4)
  • For the multiple-dose study: moderate stroke patients (NIHSS score 5-12, inclusive of 5 and 12)
  • Pre-stroke mRS score ≤ 1
  • Subjects or their guardians voluntarily sign the informed consent form

Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

This page is information, not medical advice. Discuss any trial with your doctor.