AuthorisedTherapeutic exploratory (Phase II)Interventional

StroKE34 Study Protocol: a randomized Controlled Phase IIa trial of intra-arterial Cd34+ Cells in acute ischemic Stroke

This research, called the StroKE34 Study, is investigating a new approach to treating people who have recently experienced a stroke caused by a blockage in the brain (ischemic stroke). The study is in an early stage (Phase II) and focuses on giving patients a treatment made from special cells called Cd34+. These cells are given directly into the affected artery in the brain. The main goal is to find out if this treatment can reduce the amount of brain tissue damaged by the stroke when measured three months after the event. Researchers will also look at whether it helps with movement, thinking, speech, and overall quality of life.

At a glance

Status

Authorised

Phase

Therapeutic exploratory (Phase II)

Sponsor

Unidade Local De Saude De Coimbra E.P.E.

Enrolment target

Start

30 Jan 2025

Ischemic Stroke

What is this study about?

Imagine your brain is like a complex network of roads. When you have an ischemic stroke, it's like one of those roads gets blocked, stopping blood flow to a part of your brain. This can lead to damage because that part of the brain isn't getting the oxygen and nutrients it needs. Doctors and scientists are always looking for new ways to limit this damage and help people recover better after a stroke. This study, called StroKE34, is one of those efforts.

This particular study is looking into a new treatment that uses special cells, called Cd34+ cells, which are given directly into the affected blood vessel in the brain. These cells are thought to have properties that could help protect brain tissue and aid in its repair. The treatment itself is known as Strimvelis. By giving these cells, the researchers hope to reduce the amount of brain tissue that is permanently damaged by the stroke.

To see if this treatment works, the main thing the doctors will measure is the size of the damaged area in the brain three months after the stroke. They will also be carefully checking many other important aspects of recovery. This includes looking at how well people can move, their thinking abilities, how they speak, their mood, and their overall quality of life. By measuring all these things, the study aims to get a full picture of the treatment's potential effects.

Key takeaways

This study is testing a new cell-based treatment for ischemic stroke.
The main goal is to see if it can reduce brain damage three months after a stroke.
It's an early-stage study (Phase II) exploring potential benefits.
Researchers will also track improvements in movement, thinking, and quality of life.
Participation involves receiving the treatment and follow-up assessments.

Who may be eligible?

To be considered for this study, you must have recently had a stroke caused by a blood clot in the brain. There is no upper age limit, meaning people of all adult ages can potentially take part, as long as they are at least 18 years old.

Both men and women are welcome to participate in this research. The study aims to include a diverse group of patients to understand how the treatment might work for different individuals.

Other specific medical criteria will also apply, which a doctor involved in the study would need to discuss with you. These criteria are in place to make sure the study is safe for you and that the results are as clear as possible.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Have I recently suffered an ischemic stroke (stroke due to a clot)?
Am I 18 years old or older?
Am I willing to have follow-up visits and tests for at least three months?
Do I understand that there are other specific medical requirements?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would receive the investigational treatment, which involves an infusion of Cd34+ cells into the artery affected by your stroke. You would have several visits to the hospital for checks and tests, especially during the initial period after your stroke. These appointments will help the study team monitor your health, how you are recovering, and any effects of the treatment.

Over the course of three months, you will undergo various assessments. These include scans to measure the size of the stroke damage, as well as tests to check your movement, balance, speech, memory, and mood. For example, they might ask you to do tasks to assess your walking speed, limb movement, and ability to swallow. You'll also be asked about your general health and quality of life. The study aims to follow your progress for at least three months after the treatment.

Potential risks and benefits

Taking part in a clinical trial means you might be among the first to benefit from a new treatment that could help reduce stroke damage and improve recovery. However, as this treatment is still in the testing phase, there's no guarantee it will work for everyone, and it might not provide any direct benefit. There could also be potential risks or side effects from the treatment or the procedures involved, which your doctor will explain in detail. You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Portugal

Common questions

What kind of stroke is this study for?

This study is specifically for ischemic stroke, which happens when a blood clot blocks blood flow to part of the brain.

What are Cd34+ cells?

These are special cells that are being studied for their potential to help protect and repair damaged brain tissue after a stroke.

How long will the study last for me?

Your progress will be followed and assessed for at least three months after receiving the treatment.

Will I know if I'm getting the active treatment or a placebo?

This is a 'randomized controlled' study, meaning some participants might receive the active treatment and some might receive a standard care or placebo. The study design helps doctors accurately compare the new treatment's effects.

What aspects of my recovery will the study look at?

The study will look at many things, including the size of the stroke damage, how well you can move, your thinking skills, speech, mood, and overall quality of life.