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

NCT05993884 | Completed Phase 1 DMC

• 1 other identifier: CNYX-2020-003
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 2

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.

Conditions

Acute Ischemic Stroke

Keywords

Acute Ischemic Stroke; EPCs; phase Ⅰ

Outcome Measures

Primary Outcomes (1)

• Evaluate the Incidence and severity of adverse events after iEPCs infusion

  Incidence and severity of adverse events assessed by CTCAE V5.0 during the twelve-month study period after iEPCs infusion.

  baseline to 1 year

Other Outcomes (10)

• HLA matching

  From enrollment to the end of treatment at 1 year

• plasma HLA antibody

  From enrollment to the end of treatment at 14 days, 1 month and 3 months

• plasma T lymphocytes

  From enrollment to the end of treatment at 1 day , 3 days, 7 days, 14 days, 21 days, 1 month , 3 months, 6 months, 9 months, 12 months

Study Arms (4)

Experimental: Cohort 1

EXPERIMENTAL

1X level dose of iEPCs

Drug: iEPCs

Experimental: Cohort 2

EXPERIMENTAL

3X level dose of iEPCs or placebo

Drug: iEPCs; Drug: Placebo

Experimental: Cohort 3

EXPERIMENTAL

6X level dose iEPCs or Placebo

Drug: iEPCs; Drug: Placebo

Experimental: Cohort 4

EXPERIMENTAL

10X level dose of iEPCs or placebo

Drug: iEPCs; Drug: Placebo

Interventions

iEPCs DRUG

Patients receive iEPCs IV with the single dose

Also known as: iPSC EPCs

Experimental: Cohort 1; Experimental: Cohort 2; Experimental: Cohort 3; Experimental: Cohort 4

Placebo DRUG

Patients receive placebo IV with a single dose

Also known as: iEPCs excipients

Experimental: Cohort 2; Experimental: Cohort 3; Experimental: Cohort 4

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Able to provide consent to study or consent is obtained from the patient's legal representative
• Male or females,aged 18 to 80 years
• \. 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;
• Subjects with NIHSS score between≥6 points and≤24 points at the time of screening
• Eligible patients of childbearing potential(both men and women)if sexually active must agree to use a reliable method of contraception with their partners

You may not qualify if:

• Impaired consciousness (NIHSS score Ia ≥ 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;
• Those who have bleeding conversion as assessed by imaging after thrombolysis and/or thrombolysis;
• History of previous intracranial hemorrhage (within 1 year), arteriovenous malformations, arterial entrapment, aneurysm (≥3 mm in maximum diameter), epilepsy, and history of brain tumor;
• Abnormalities in major organ function
• \. 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.

Sponsors & Collaborators

• Allife Medical Science and Technology Co., Ltd.: lead
• Linfen Central Hospital: collaborator
• Peking University Third Hospital: collaborator
• Xuanwu Hospital, Beijing: collaborator
• Beijing Tiantan Hospital: collaborator
• Linyi People's Hospital: collaborator

Study Sites (2)

Allife Medicine （Beijing） Limitied

Beijing, Beijing Municipality, 100053, China

Location

Allife

Beijing, Beijing Municipality, China

Location

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 27, 2023
• First Posted: August 15, 2023
• Study Start: August 24, 2023
• Primary Completion: April 15, 2025
• Study Completion: April 15, 2025
• Last Updated: August 12, 2025

Record last verified: 2025-08

Locations

CN (2)