Evaluating the effects of exosomes 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.
This study is testing if a new treatment using exosomes from stem cells can help people who have had an acute ischemic stroke feel better and recover safely.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 29 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Xuanwu Hospital, Beijing Academic / other |
| Locations | 1 site (Beijing) |
| Trial ID | NCT06138210 on ClinicalTrials.gov |
What this trial studies
This multicenter, randomized, double-blinded, placebo-controlled, dose-escalation trial aims to assess the safety and preliminary efficacy of intravenous exosomes derived from human induced pluripotent stem cells (GD-iExo-003) in patients with acute ischemic stroke. The study consists of two parts: the first part involves a traditional 3+3 dose escalation design to determine the maximum tolerated dose, while the second part will randomize subjects to receive either the exosome treatment or a placebo. Participants will be monitored for dose-limiting toxicities and overall safety throughout the trial.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-70 with a clinical diagnosis of acute ischemic stroke and specific NIHSS scores.
Not a fit: Patients with severe comorbidities or those outside the specified age range may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a novel therapeutic option for improving outcomes in patients with acute ischemic stroke.
How similar studies have performed: While the use of exosomes in stroke treatment is a novel approach, similar studies have shown promise in other conditions, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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.
Where this trial is running
Beijing
- Xuanwu Hospital, Capital Medical University — Beijing, China (Recruiting)
Study contacts
- Principal investigator: Junwei Hao, MD; PhD — Xuanwu Hospital, Beijing
- Study coordinator: Junwei Hao, MD; PhD
- Email: haojunwei@vip.163.com
- Phone: 010 8319 8277
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.