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

Acute Ischemic Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05993884
• Other study ID #: CNYX-2020-003
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: August 15, 2023
• Est. completion date: August 15, 2025

Study information

• Verified date: August 2023
• Source: Allife Medical Science and Technology Co., Ltd.
• Contact: Xingquan Zhao, Dr
• Phone: 01059978555
• Email: ttyyirb[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 27
• Est. completion date: August 15, 2025
• Est. primary completion date: August 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Ischemic Stroke
• Cerebral Infarction
• Ischemia
• Ischemic Stroke
• Stroke

Intervention

Drug:
• iEPCs
Given: IV

Combination Product:
• Clinical standard treatment (CST)
Clinical standard treatment

Locations

Country	Name	City	State
China	Allife	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Allife Medical Science and Technology Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	HLA matching	the level of HLA matching pairs of donor/recipient	1 year
Other	plasma HLA antibody	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.	month 1, month 3, month 6, month 9, month 12
Other	plasma T lymphocytes	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.	month 1, month 3, month 6, month 9, month 12
Other	plasma iEPCs	The change from the baseline in plasma iEPCs will be calculated at month 1, month 3 post infusion, as available.	month 1, month 3
Other	Modified Rankin Scale, mRS	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).	month 1, month 3, month 6
Other	National Institute of Health stroke scale, NIHSS	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.	month 1, month 3, month 6
Other	activity of daily living, ADL	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.	month 1, month 3, month 6
Other	cerebral infarct volume	The change from baseline in cerebral infarct volume using MRI will be calculated at month 1, month 3, month 6 post-treatment, as available.	month 1, month 3, month 6
Other	vascular endothelial growth factor, VEGF	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.	month 1, month 3, month 6, month 9, month 12
Other	brain derived neurotrophic factor,BDNF	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.	month 1, month 3, month 6, month 9, month 12
Primary	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