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

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

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

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.

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.

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

The change from the baseline of plasma HLA antibody will be calculated at month 1, month 3, month 6, month 9, month 12 post infusion, as available.

The change from the baseline in plasma T lymphocytes will be calculated at month 1, month 3, month 6, month 9, month 12 post infusion, as available.

The change from the baseline in plasma iEPCs will be calculated at month 1, month 3 post infusion, as available.

The change from the baseline in mRS will be calculated at month 1, month 3, month 6, as available. The scale is divided into 7 degrees, from 0 (no deficit) to 6 (dead).

The change from the baseline in NIHSS will be calculated at month 1, month 3, month 6 post-treatment, as available. The range of scores is from 0 (normal) to 42.

The change from the baseline in ADL will be calculated at month 1, month 3, month 6 post-treatment, as available. Every activity will be scored 5 and the range of scores is from 0 (normal) to 5.

The change from baseline in cerebral infarct volume using MRI will be calculated at month 1, month 3, month 6 post-treatment, as available.

Changes of concentration of vascular endothelial growth factor（VEGF）in the serum from the baseline will be calculated at month 1, month 3, month 6, month 9, month 12 post-treatment, as available.

Changes of concentration of brain derived neurotrophic factor (BDNF) in the serum from the baseline will be calculated at month 1, month 3, month 6, month 9, month 12 post-treatment, as available.

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