Study on the Effects of CD34+ Cells for Patients with Acute Ischemic Stroke

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What is this study about?

This clinical trial is focused on studying the effects of a treatment for patients who have experienced an ischemic stroke. An ischemic stroke occurs when a blood clot blocks or narrows an artery leading to the brain, causing a reduction in blood flow and potentially damaging brain cells. The treatment being tested involves the use of CD34+ cells, which are a type of stem cell. These cells are administered directly into the arteries to see if they can help reduce the size of the brain area affected by the stroke.

The purpose of the study is to evaluate how effective these CD34+ cells are in reducing the damage caused by the stroke. Participants in the study will receive the treatment within either 7 days or 20 days after their stroke. The study will monitor the size of the affected brain area over a period of three months to determine the treatment’s impact. The study will also assess various aspects of recovery, such as physical function, cognitive performance, and quality of life, using different scales and tests.

This trial is part of ongoing research to find better ways to treat ischemic stroke and improve recovery outcomes for patients. By exploring the potential benefits of CD34+ cells, researchers hope to develop new therapies that can help reduce the long-term effects of strokes and enhance the quality of life for those affected.

1 initial assessment

Eligibility is determined based on specific criteria, including age between 18 and 80 years, a recent ischemic stroke, and the ability to provide informed consent.

A medical evaluation is conducted to confirm the stroke and assess the patient’s condition.

2 randomization

Patients are randomly assigned to receive either the treatment or a control intervention.

This process ensures that the study results are unbiased and scientifically valid.

3 treatment administration

The treatment involves an intra-arterial infusion of CD34+ cells, which are a type of stem cell.

The infusion is administered through a vein, and the dosage is between 1 to 10 million cells per milliliter.

4 monitoring and follow-up

Patients are monitored for any immediate reactions to the treatment.

Regular follow-up visits are scheduled to assess recovery and any changes in health status.

5 evaluation of outcomes

The primary outcome is the volume of the brain affected by the stroke, measured three months after treatment.

Secondary outcomes include assessments of physical function, cognitive performance, quality of life, and emotional well-being.

6 final assessment

A comprehensive evaluation is conducted at the end of the study period to determine the overall effectiveness of the treatment.

This includes a review of all collected data and patient feedback.

Who Can Join the Study?

Age between 18 and 80 years.
Have experienced an acute hemispheric ischemic stroke. This means a sudden stroke affecting one side of the brain, caused by a blockage in a blood vessel.
The stroke must be related to an injury in the area supplied by the Middle Cerebral Artery (MCA), which is a major artery in the brain.
The blocked artery must be open again at the time of joining the study.
The stroke must have started within 7 days before joining the study. The start time is when the person was last seen normal or went to bed if the stroke happened during sleep.
Must have easy access to veins for taking blood samples.
Must understand the study requirements and agree to participate by signing a consent form. If the person cannot consent, a legal representative can do so on their behalf.
Must have a NIHSS score of at least 6. The NIHSS is a scale used to measure the severity of a stroke, with higher numbers indicating more severe symptoms.

Who Cannot Join the Study?

Patients who have had a recent ischemic stroke. An ischemic stroke happens when a blood vessel that supplies blood to the brain is blocked by a blood clot.
Patients who are not in the early (7 days) or late (20 days) subacute stage of recovery from an ischemic stroke. The subacute stage is the period after the initial treatment of a stroke.
Patients who are not within the specified age range for the study. The age range is typically defined by the study and can vary.
Patients who belong to a vulnerable population. This means groups of people who might be at a higher risk of harm or exploitation.

Where you can join this trial?

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Trial status

Country	Status	Recruitment Start
Portugal	Not yet recruiting	01.07.2025

Trial locations

Investigated drugs:

AUTOLOGOUS CD34+ ENRICHED CELL FRACTION THAT CONTAINS CD34+ CELLS TRANSDUCED WITH RETROVIRAL VECTOR THAT ENCODES FOR THE HUMAN ADA CDNA SEQUENCE

CD34+ Cells are a type of stem cell used in this clinical trial. These cells are administered directly into the arteries of patients who have experienced an acute ischemic stroke. The goal of using these cells is to assess their effect on reducing the size of the brain infarct, which is the area of tissue that has been damaged due to the stroke. The treatment is given either early, within 7 days, or later, within 20 days after the stroke, to see how timing affects the outcome.

Investigated diseases:

Ischaemic stroke

Ischemic Stroke – Ischemic stroke occurs when a blood clot blocks or narrows an artery leading to the brain, resulting in reduced blood flow and oxygen to brain tissue. This blockage can cause brain cells to begin dying within minutes. Symptoms often include sudden numbness or weakness, especially on one side of the body, confusion, trouble speaking, or difficulty understanding speech. As the condition progresses, it may lead to problems with vision, balance, and coordination. The severity and specific symptoms depend on the area of the brain affected and the duration of the blood flow interruption. Recovery and progression can vary widely among individuals, with some experiencing significant improvement and others facing long-term challenges.

Trial ID:

2025-520850-13-00

Protocol code:

2017-002456-88

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on the Effects of CD34+ Cells for Patients with Acute Ischemic Stroke

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?