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RecruitingPhase 1Phase 2NCT06138210

The Effect of GD-iExo-003 in Acute Ischemic Stroke

The Effect of Exosomes Derived From Human Induced Pluripotent Stem Cell (GD-iExo-003) in Acute Ischemic Stroke: an Exploratory Study.

Sponsor

Xuanwu Hospital, Beijing

Enrollment

29 participants

Start Date

Jun 5, 2024

Study Type

INTERVENTIONAL

Conditions

Acute Ischemic Stroke

Summary

This is a multicenter, randomized, double-blinded, placebo-controlled, dose-escalation trial. The objective of this study is evaluating safety and preliminary efficacy of intravenous exosomes derived from human induced pluripotent stem cell (GD-iExo-003) in acute ischemic stroke.

Eligibility

Min Age: 18 YearsMax Age: 70 Years

Inclusion Criteria10

  • Clinical diagnosis of acute ischemic stroke
  • Age 18-70 years, inclusion of both genders
  • Modified Rankin Scale score before stroke of 0-1
  • NIHSS score 6-20 at inclusion that did not change by ≥4 points from screening to baseline assessment.
  • Time of stroke onset is known and treatment can be started between day 1 and 7 of onset.
  • Confirmation of hemispheric cortical infarct with magnetic resonance imaging or computed tomography
  • Subjects who received intravenous thrombolysis or underwent mechanical reperfusion are eligible if they meet all other eligibility criteria.
  • Adequate hepatic and renal function: serum aspartate aminotransferase ≤2.5× upper limit of normal; serum alanine aminotransferase ≤2.5× upper limit of normal; blood urea nitrogen ≤1.25× upper limit of normal; serum creatinine ≤1.25× upper limit of normal
  • Adequate cardiac function.
  • Subjects or legal representative can sign the informed consent and must be willing and able to comply with all aspects of treatment and follow-up schedule.

Exclusion Criteria15

  • Presence of intracranial hemorrhage on CT including hemorrhagic stroke, epidural hematoma, subdural hematoma, intraventricular hemorrhage, intraventricular hemorrhage, subarachnoid hemorrhage or hemorrhagic transformation, etc.
  • Presence of a lacunar or a brainstem infarct as the etiology of current symptoms.
  • Evidence of brain tumor or history of epilepsy or traumatic brain injury.
  • Subjects with present malignant disease.
  • Subjects with severe comorbidities including immunodeficiency or coagulation disorders.
  • Subjects with Alzheimer's disease, Parkinson's disease or other degenerative neurological disease.
  • Ongoing systemic infection, severe local infection or taking immunosuppressants.
  • Subjects with positive hepatitis B surface antibody (HBsAg) and positive hepatitis B core antibody (HBcAb), or HBsAg-positive virus carriers, positive hepatitis C antibody, positive syphilis antibody or HIV
  • Allergy to the study products.
  • Documented allergies
  • Participation in any clinical trial in the last 3 months
  • Inability or unwillingness to comply with the study schedule
  • Pregnancy, childbearing potential (unless it is certain that pregnancy is not possible), oe breast feeding
  • Other serious medical or psychiatric illness that is not adequately controlled
  • Other circumstances that the investigator considers inappropriate for participation in the trial.

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Interventions

DRUGexosomes derived from human induced pluripotent stem cell for injection

Exosomes derived from human induced pluripotent stem cell for injection (3.0ml, 1×10\^11particles/ml).

DRUGa placebo of exosomes derived from human induced pluripotent stem cell for injection

Exosomes placebo, 3.0ml

Locations(1)

Xuanwu Hospital, Capital Medical University

Beijing, China

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NCT06138210

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