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

NCT06138210 | Recruiting Phase 1 DMC

• 1 other identifier: XMEC-2023-004
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Acute Ischemic Stroke

Keywords

exosome

Outcome Measures

Primary Outcomes (1)

• Incidence of severe adverse events

  The proportion of patients who experienced severe adverse events.

  90±7 days

Secondary Outcomes (7)

• Favorable functional outcome

  90±7 days

• Functional outcome

  90±7 days

• NIHSS score change

  14±2 days

• NIHSS score change

  90±7 days

• Quality of Life (EQ-5D-5L)

  90±7 days

Other Outcomes (4)

• Change of infarct volume

  14±2 days

• Blood marker changes from baseline to discharge

  at discharge, an average of 14 days

• Degree of cerebral edema changes from baseline to 48 hours

  48 hours

Study Arms (2)

Exosomes group

EXPERIMENTAL

Patients in this arm will be given exosomes derived from human induced pluripotent stem cell for injection once a day for 7 days.

Drug: exosomes derived from human induced pluripotent stem cell for injection

Exosomes placebo group

PLACEBO COMPARATOR

Patients in this arm will be given a placebo of exosomes derived from human induced pluripotent stem cell for injection once a day for 7 days.

Drug: a placebo of exosomes derived from human induced pluripotent stem cell for injection

Interventions

exosomes derived from human induced pluripotent stem cell for injection DRUG

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

Also known as: GD-iExo-003

Exosomes group

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

Exosomes placebo, 3.0ml

Also known as: GD-iExo-003 placebo

Exosomes placebo group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical diagnosis of acute ischemic stroke
• Modified Rankin Scale score before stroke of 0-1
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xuanwu Hospital, Beijing: lead
• Guidon Pharmaceutics Ltd.: collaborator

Study Sites (1)

Xuanwu Hospital, Capital Medical University

Beijing, 100053, China

RECRUITING

MeSH Terms

Conditions

Ischemic Stroke

Interventions

Injections

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Junwei Hao, MD; PhD

  Xuanwu Hospital, Beijing

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Junwei Hao, MD; PhD

CONTACT

010 8319 8277; haojunwei@vip.163.com

Gaoting Ma, MD

CONTACT

18301579891; demo_doctor@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Neurology Department

Study Record Dates

• First Submitted: November 12, 2023
• First Posted: November 18, 2023
• Study Start: June 5, 2024
• Primary Completion: March 30, 2026
• Study Completion: March 30, 2026
• Last Updated: December 4, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)