The Effect of GD-iExo-003 in Acute Ischemic Stroke
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: exosomes derived from human induced pluripotent stem cell for injection, a placebo of exosomes derived from human induced pluripotent stem cell for injection.
- Who it may be relevant to
- Registry conditions: Acute Ischemic Stroke. Basic parameters: 18 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
The Effect of Exosomes Derived From Human Induced Pluripotent Stem Cell (GD-iExo-003) in Acute Ischemic Stroke: an Exploratory Study.
Overview
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.
Detailed description
This is a multicenter, randomized, double-blinded, placebo-controlled, dose-escalation trial. This study will consist of 2 parts, with part 1 being a dose-escalation study and part 2 being an expanded safety study based on part 1 findings.
A traditional 3+3 dose escalation design will be implemented in part 1. Cohort 1: receive 2×10\^9 particles/kg; cohort 2: 4×10\^9 particles/kg and cohort 3: 8×10\^9 particles/kg. If no dose-limiting toxicities (DLTs) are observed for 2 weeks after administration of the first injection, a new cohort will be enrolled at the next planned dose level. If DLTs are observed in 1 participant in the cohort, another 3 participants will be treated in the same dose level. Dose escalation will be stopped until DLTs are observed in \>33% of the participants.
In part 2, 20 subjects will be randomized in a 1:1 ratio \[exosome (n=10) or exosome placebo (n=10)\]. The dose level will be determined by Data Safety Monitoring Board based on part 1.
Interventions
- Drug exosomes 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). - Drug a placebo of exosomes derived from human induced pluripotent stem cell for injection
Exosomes placebo, 3.0ml
Primary outcome measures
- Incidence of severe adverse events [Time frame: 90±7 days]
Secondary outcome measures (7)
- Favorable functional outcome [Time frame: 90±7 days]
- Functional outcome [Time frame: 90±7 days]
- NIHSS score change [Time frame: 14±2 days]
- NIHSS score change [Time frame: 90±7 days]
- Quality of Life (EQ-5D-5L) [Time frame: 90±7 days]
- Barthel Index (BI) [Time frame: 90±7 days]
- MoCA [Time frame: 90±7 days]
Eligibility 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Sequential
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- Xuanwu Hospital, Capital Medical University — Beijing
Identifiers
NCT: NCT06138210 · XMEC-2023-004