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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 10 June 2024
Main ID:  NCT06138210
Date of registration: 12/11/2023
Prospective Registration: Yes
Primary sponsor: Xuanwu Hospital, Beijing
Public title: The Effect of GD-iExo-003 in Acute Ischemic Stroke ExoCURE
Scientific title: The Effect of Exosomes Derived From Human Induced Pluripotent Stem Cell (GD-iExo-003) in Acute Ischemic Stroke: an Exploratory Study.
Date of first enrolment: May 27, 2024
Target sample size: 29
Recruitment status: Recruiting
URL:  https://clinicaltrials.gov/ct2/show/NCT06138210
Study type:  Interventional
Study design:  Allocation: Randomized. Intervention model: Sequential Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).  
Phase:  Phase 1
Countries of recruitment
China
Contacts
Name:     Junwei Hao, MD; PhD
Address: 
Telephone: 010 8319 8277
Email: haojunwei@vip.163.com
Affiliation: 
Name:     Junwei Hao, MD; PhD
Address: 
Telephone:
Email:
Affiliation:  Xuanwu Hospital, Beijing
Name:     Gaoting Ma
Address: 
Telephone: 18301579891
Email: demo_doctor@163.com
Affiliation: 
Key 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 negative 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.



Age minimum: 18 Years
Age maximum: 70 Years
Gender: All
Health Condition(s) or Problem(s) studied
Acute Ischemic Stroke
Intervention(s)
Drug: a placebo of exosomes derived from human induced pluripotent stem cell for injection
Drug: exosomes derived from human induced pluripotent stem cell for injection
Primary Outcome(s)
Number of participants who experienced dose-limiting Toxicities (DLTs) [Time Frame: 14±2 days]
Secondary Outcome(s)
Functional outcome [Time Frame: 90±7 days]
Favorable functional outcome [Time Frame: 90±7 days]
Barthel Index (BI) [Time Frame: 90±7 days]
Quality of Life (EQ-5D-5L) [Time Frame: 90±7 days]
NIHSS score change [Time Frame: 14±2 days]
Incidence of severe adverse events [Time Frame: 90±7 days]
NIHSS score change [Time Frame: 7 days]
Secondary ID(s)
XMEC-2023-004
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Guidon Pharmaceutics Ltd.
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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