Clinical Trial of Human Umbilical Cord Mesenchymal Stem Cells (IxCell hUC-MSC-S) in the Treatment of Ischemic Stroke

NCT05697718 | Completed Phase 1

• 1 other identifier: LC-MSC-IS21004
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 2

Brief Summary

To evaluate the safety and tolerability of IxCellhUC-MSC-S as a single intravenous infusion in convalescent patients with ischemic stroke. To explore the efficacy of IxCellhUC-MSC-S as a single intravenous infusion in patients with convalescent ischemic stroke.

Conditions

Ischemic Stroke

Outcome Measures

Primary Outcomes (8)

• Safety and tolerability

  Adverse events and serious adverse events

  24 weeks

• Laboratory test：blood routine

  24 weeks

• Laboratory test：urine routine

  24 weeks

• Laboratory test：blood biochemistry

  24 weeks

• Laboratory test：coagulation function

  24 weeks

• 12-lead electrocardiogram

  24 weeks

• Head magnetic resonance imaging（MRI）

  24weeks

• Physical examination

  24weeks

Secondary Outcomes (6)

• Preliminary efficacy

  24 weeks

• Preliminary efficacy

  24 weeks

• Preliminary efficacy

  24 weeks

• Preliminary efficacy

  24 weeks

• Preliminary efficacy

  24 weeks

Study Arms (3)

group 1

EXPERIMENTAL

Human umbilical cord mesenchymal stem cells（hMSCs）5.0×10\^7 cells

Biological: MSC

group 2

EXPERIMENTAL

Human umbilical cord mesenchymal stem cells（hMSCs）10.0×10\^7 cells

Biological: MSC

group 3

EXPERIMENTAL

Human umbilical cord mesenchymal stem cells（hMSCs）20.0×10\^7 cells

Biological: MSC

Interventions

MSC BIOLOGICAL

a single injection dose i.v.

group 1; group 2; group 3

Eligibility Criteria

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

You may qualify if:

• to 80 years old, both sexes;
• Diagnosed with ischemic stroke of the anterior circulation at 12-24 weeks after the first stroke symptom onset (including W12 and W24);
• National Institutes of Health Stroke Scale (NIHSS) score 6-20 points, and NlHSS score item 1a \< 2 points;
• Life expectancy ≥ 12 months;
• Understand and comply with the study process, with informed consent form voluntarily signed by the patient or the authorized representatives.

You may not qualify if:

• Current or previous epilepsy, dementia, Parkinson's disease, major depression, or other neurological disorders or mental illnesses that the investigator believes will affect their ability to participate in the study or affect the study evaluation;
• Current or past intracranial hemorrhagic diseases (such as: cerebral hemorrhage, epidural hematoma, subdural hematoma, subarachnoid hemorrhage, ventricle hemorrhage, traumatic cerebral hemorrhage, etc.) or cerebral tumors, history of brain trauma, encephalitis and other symptoms leading to apoplexy;
• Current or past severe cardiovascular disease；
• Patients with pulmonary embolism, interstitial pneumonia, radiation pneumonia, drug-related pneumonia, severe impairment of lung function and other severe lung infections or other lung diseases (except those caused by stroke, bed rest after stroke or stroke treatment);
• Organ function level meet the following any one or more:
• absolute neutrophil cell count (ANC) \< 1.5×109/L, platelet (PLT) \< 100×109/L, hemoglobin (Hb) \< 90g/L; Aspertate aminotransferase (AST) \> 2.5×normal limit (ULN) and/or alanine aminotransferase (ALT) \> 2.5×ULN, serum total bilirubin (TBIL) \> 1.5×ULN; Creatinine (Cr) \> 1.5×ULN; The international normalized ratio (INR) for those who did not receive anticoagulant or antithrombotic therapy \> 1.7 or activated partial thromboplastin time (APTT) \> 1.25×ULN, the international normalized ratio(INR) for those using anticoagulant or antithrombotic therapy \> 3.0 or activated partial thromboplastin time (APTT) \> 1.50×ULN.
• Hepatitis B virus surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) positive for HBV-DNA, positive for hepatitis C virus antibody (HCVAb), treponema pallidum antibody (TPAb/RPR) or human immunodeficiency virus antibody (HIV), or within 14 days prior to receiving the test drug treatment,The emergence of any infected persons in need of systematic anti-infective treatment;
• Allergic constitution or history, or allergic to the test drug or any component of the test drug;
• Patients with MRI contraindications;
• Positive blood pregnancy test results for female subjects of reproductive age within 7 days prior to receiving the experimental drug treatment;All women of reproductive age, fertile men or their spouses who refused to use appropriate contraception (including at least one barrier contraceptive) throughout the study period, and lactating women;
• Those who required systemic corticosteroids (\> 10mg/ day prednisone therapeutic dose) or other immunosuppressive agents within 14 days prior to receiving the trial drug or during the study period;
• Patients who used butylphthalein within 3 weeks before receiving the experimental drug;
• participated in any clinical trial and took any investigational drug within 3 months prior to receiving the investigational drug treatment (or the last time receiving the investigational drug did not exceed 5 half-lives, whichever is longer);
• Patients who had severe trauma or major surgery within 3 months before receiving the experimental drug treatment, or who plan to undergo surgery during the trial period;Patients with a history of blood transfusion within 3 months before receiving the experimental drug treatment;
• Those who had a history of drug abuse or alcoholism within 1 year before receiving the experimental drug treatment;

Sponsors & Collaborators

• Shanghai IxCell Biotechnology Co., LTD: lead

Study Sites (2)

Xuanwu Hospital of Capital Medical University

Beijing, Beijing Municipality, China

Location

Xuanwu Hospital of Capital Medical University

Beijing, 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 Officials

• junwei Hao, Doctor

  Xuanwu Hospital of Capital Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 27, 2022
• First Posted: January 26, 2023
• Study Start: April 10, 2023
• Primary Completion: July 29, 2024
• Study Completion: August 27, 2024
• Last Updated: February 12, 2026

Record last verified: 2025-12

Locations

CN (2)