Safety and Preliminary Efficacy of Allogeneic Endothelial Progenitor Cells (EPCs) in Patients With Acute Ischemic Stroke

NCT ID: NCT05993884

Last Updated: 2025-08-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 27 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-24
• Study Completion Date: 2025-04-15

Brief Summary

This is a multicenter, randomized, double-blind, placebo-controlled, dose-Escalation clinical study to investigate the safety and efficacy of EPCs transplantation in Acute ischemic stroke.

Detailed Description

Acute ischemic stroke (AIS) occurs when blood flow to the brain is blocked by a clot or mechanical event and is the most common type of stroke. However, due to the limitation of time and contraindications, only a few patients with AIS are eligible candidates. Endothelial progenitor cells (EPCs) have the potential to reduce brain damage from AIS. They can effectively repair endothelial cells with vascular injuries by directly differentiating into endothelial cells or releasing corresponding regulatory factors, which is a potentially important means for the prevention and treatment of a series of vascular system disorders. The introduction of induced pluripotent stem cells (iPSCs) technology provides a highly feasible option for clinical application of EPCs. Allogeneic iPSC-EPCs can be produced on a large scale to provide enough cells, fundamentally solving the problem of insufficient dosage, and making them a feasible clinical option for treatment of AIS.

Conditions

Acute Ischemic Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Experimental: Cohort 1

1X level dose of iEPCs

Group Type: EXPERIMENTAL

iEPCs

Intervention Type: DRUG

Patients receive iEPCs IV with the single dose

Experimental: Cohort 2

3X level dose of iEPCs or placebo

Group Type: EXPERIMENTAL

iEPCs

Intervention Type: DRUG

Patients receive iEPCs IV with the single dose

Placebo

Intervention Type: DRUG

Patients receive placebo IV with a single dose

Experimental: Cohort 3

6X level dose iEPCs or Placebo

Group Type: EXPERIMENTAL

iEPCs

Intervention Type: DRUG

Patients receive iEPCs IV with the single dose

Placebo

Intervention Type: DRUG

Patients receive placebo IV with a single dose

Experimental: Cohort 4

10X level dose of iEPCs or placebo

Group Type: EXPERIMENTAL

iEPCs

Intervention Type: DRUG

Patients receive iEPCs IV with the single dose

Placebo

Intervention Type: DRUG

Patients receive placebo IV with a single dose

Interventions

iEPCs

Patients receive iEPCs IV with the single dose

Intervention Type: DRUG

Placebo

Patients receive placebo IV with a single dose

Intervention Type: DRUG

Other Intervention Names

iPSC EPCs; iEPCs excipients

Eligibility Criteria

Inclusion Criteria

• 1.Able to provide consent to study or consent is obtained from the patient's legal representative
• 2.Male or females,aged 18 to 80 years
• 3. Subjects with acute ischemic stroke:1) Onset time ≤ 7 days; 2) Imaging confirmed infarction in the blood-supplying area of the internal carotid artery; 3) treated with thrombolysis and/or thrombolysis, or without the above treatment;
• 4.Subjects with NIHSS score between≥6 points and≤24 points at the time of screening
• 5.Eligible patients of childbearing potential(both men and women)if sexually active must agree to use a reliable method of contraception with their partners

Exclusion Criteria

1. Impaired consciousness (NIHSS score Ia ≥ 2);

2. Disease progression or fluctuation in the subject after the first visit to the screening enrollment, which in the judgment of the investigator has a poor prognosis and will not benefit from this clinical study;

3. Those who have bleeding conversion as assessed by imaging after thrombolysis and/or thrombolysis;

4. History of previous intracranial hemorrhage (within 1 year), arteriovenous malformations, arterial entrapment, aneurysm (≥3 mm in maximum diameter), epilepsy, and history of brain tumor;

5. Abnormalities in major organ function

7. severe respiratory disease that, as assessed by the investigator, may have an impact on the subject's determination of test results (active tuberculosis, chronic obstructive pulmonary disease, interstitial lung disease, severe or critical pneumonia); 8. Uncontrolled hypertension (systolic blood pressure ≥180 mmHg or diastolic blood pressure ≥110 mmHg) after treatment, which in the judgment of the investigator carries a high risk of bleeding and has a poor prognosis; 9. Those with malignant tumors or a history of malignant tumors; 10. Have an autoimmune disease or are undergoing immunotherapy; 11. Being pregnant or breastfeeding; 12. Allergic to multiple drugs (≥2) or allergic to human albumin; 13. have been alcohol- or drug-dependent in the 6 months prior to the onset of illness or have had an episode of acute alcoholism in the 24 h prior to the onset of illness or have had an episode of Those with acute alcohol intoxication within 24 h; 14. History of psychiatric illness or severe cognitive impairment that may affect the evaluation of neurologic function; 15. Positive for Hepatitis B surface antigen, positive for Hepatitis C virus antibody, positive for syphilis serum antibody or positive for HIV antibody; 16. Being enrolled in a clinical study of another drug; 17. Patients who, in the opinion of the investigator, are not suitable for participation in this study.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Linfen Central Hospital

UNKNOWN

Sponsor Role: collaborator

Peking University Third Hospital

OTHER

Sponsor Role: collaborator

Xuanwu Hospital, Beijing

OTHER

Sponsor Role: collaborator

Beijing Tiantan Hospital

OTHER

Sponsor Role: collaborator

Linyi People's Hospital

OTHER

Sponsor Role: collaborator

Allife Medical Science and Technology Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Allife Medicine （Beijing） Limitied

Beijing, Beijing Municipality, China

Allife

Beijing, Beijing Municipality, China

Countries

China

Other Identifiers

CNYX-2020-003

Identifier Type: -

Identifier Source: org_study_id