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

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ClinicalTrials.gov Identifier: NCT05993884
Recruitment Status : Not yet recruiting
First Posted : August 15, 2023
Last Update Posted : August 15, 2023
Sponsor:
Information provided by (Responsible Party):
Allife Medical Science and Technology Co., Ltd.

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Acute Ischemic Stroke Drug: iEPCs Combination Product: Clinical standard treatment (CST) Phase 1

Detailed 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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 27 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Estimated Study Start Date : August 15, 2023
Estimated Primary Completion Date : August 15, 2024
Estimated Study Completion Date : August 15, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ischemic Stroke

Arms and Interventions
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Arm Intervention/treatment
Experimental: Treatment (clinical standard treatment, iEPCs)
Patients receive clinical standard treatment and iEPCs IV with a single dose
 Drug: iEPCs
Given: IV
Other Name: iPSC EPCs

Combination Product: Clinical standard treatment (CST)
Clinical standard treatment
Other Name: CST
Placebo Comparator: Placebo (clinical standard treatment, Placebo)
Patients receive clinical standard treatment and placebo IV 150 mL with a single dose
 Combination Product: Clinical standard treatment (CST)
Clinical standard treatment
Other Name: CST


Outcome Measures
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Primary Outcome Measures :
  1. Evaluate the Incidence and severity of adverse events after iEPCs infusion [ Time Frame: baseline to 1 year ]
    Incidence and severity of adverse events assessed by CTCAE V5.0 during the twelve-month study period after iEPCs infusion.


Other Outcome Measures:
  1. HLA matching [ Time Frame: 1 year ]
    the level of HLA matching pairs of donor/recipient

  2. plasma HLA antibody [ Time Frame: month 1, month 3, month 6, month 9, month 12 ]
    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.

  3. plasma T lymphocytes [ Time Frame: month 1, month 3, month 6, month 9, month 12 ]
    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.

  4. plasma iEPCs [ Time Frame: month 1, month 3 ]
    The change from the baseline in plasma iEPCs will be calculated at month 1, month 3 post infusion, as available.

  5. Modified Rankin Scale, mRS [ Time Frame: month 1, month 3, month 6 ]
    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).

  6. National Institute of Health stroke scale, NIHSS [ Time Frame: month 1, month 3, month 6 ]
    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.

  7. activity of daily living, ADL [ Time Frame: month 1, month 3, month 6 ]
    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.

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

  9. vascular endothelial growth factor, VEGF [ Time Frame: month 1, month 3, month 6, month 9, month 12 ]
    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.

  10. brain derived neurotrophic factor，BDNF [ Time Frame: month 1, month 3, month 6, month 9, month 12 ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05993884


Contacts
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Contact: Xingquan Zhao, Dr 01059978555 ttyyirb@163.com
Contact: Qian Zhang, Dr 01059978555 ttyyirb@163.com

Locations
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China, Beijing
Allife
Beijing, Beijing, China
Contact: Hui Shi    18612648904    shihui@allifetech.com   
Sponsors and Collaborators
Allife Medical Science and Technology Co., Ltd.
More Information
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Responsible Party: Allife Medical Science and Technology Co., Ltd.
ClinicalTrials.gov Identifier: NCT05993884    
Other Study ID Numbers: CNYX-2020-003
First Posted: August 15, 2023    Key Record Dates
Last Update Posted: August 15, 2023
Last Verified: August 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Allife Medical Science and Technology Co., Ltd.:
Acute Ischemic Stroke
EPCs
Additional relevant MeSH terms:
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Stroke
Ischemic Stroke
Cerebral Infarction
Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Brain Infarction
Brain Ischemia
Infarction
Necrosis