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

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

Detailed Description
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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.

Official Title
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Phase I Clinical Study on the Safety and Preliminary Efficacy of Allogeneic Endothelial Progenitor Cells (EPCs) Injection in Patients With Acute Ischemic Stroke

Conditions
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Acute Ischemic Stroke

Intervention / Treatment
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* Drug: iEPCs
* Combination Product: Clinical standard treatment (CST)


Participation Criteria
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Eligibility Criteria
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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 MRI confirmed AIS before start of 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.Subject with disturbance of consciousness 2.Subject with ischemic stroke progression or fluctuation 3.Subjects with previous history of cerebrovascular diseases 4.Subject with major organs dysfunction 5.Subjects with history of malignancy 6.Subjects with Pregnant or lactating subjects 7.Subjects with known allergy to more than 2 drugs 8.Current or recent history of alcohol or drug abuse

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment (clinical standard treatment, iEPCs)<br>Patients receive clinical standard treatment and iEPCs IV with a single dose | Drug: iEPCs<br>* Given: IV<br>* Other names: iPSC EPCs;Combination Product: Clinical standard treatment (CST)<br>* Clinical standard treatment<br>* Other names: CST;|
| Placebo Comparator: Placebo (clinical standard treatment, Placebo)<br>Patients receive clinical standard treatment and placebo IV 150 mL with a single dose | Combination Product: Clinical standard treatment (CST)<br>* Clinical standard treatment<br>* Other names: CST;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acute Ischemic Stroke, EPCs