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

• 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
• Affiliation: Xuanwu Hospital, Beijing

• Name: Junwei Hao, MD; PhD

• Name: Gaoting Ma

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]

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]

Barthel Index (BI) [Time Frame: 90±7 days]

Quality of Life (EQ-5D-5L) [Time Frame: 90±7 days]

Favorable functional outcome [Time Frame: 90±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.