AuthorisedHuman Pharmacology (Phase I)- First administration to humansInterventional

Regenerative Stem Cell Therapy for Stroke in Europe 1

This study is an early-stage clinical trial exploring a new stem cell treatment for people who have had a stroke. Strokes happen when the blood supply to part of the brain is cut off, which can cause serious problems. Stem cells are special cells that can develop into many different cell types in the body, and scientists hope they could help repair damage after a stroke. This is the very first time this specific treatment will be given to people, so the main goal is to check if it's safe and to understand how the body reacts to it. The study is open to adult men and women, aged 18 and over, who have experienced a stroke. This research is a crucial first step in seeing if this new approach could eventually help stroke survivors.

At a glance

Status

Authorised

Phase

Human Pharmacology (Phase I)- First administration to humans

Sponsor

Centre Hospitalier Universitaire Grenoble Alpes

Enrolment target

144

Start

05 Nov 2024

stroke

What is this study about?

This study is one of the initial steps in researching a new type of treatment called 'regenerative stem cell therapy' for people who have had a stroke. Think of stem cells as special building block cells in your body. They have the amazing ability to turn into many other kinds of cells, like nerve cells, and potentially help repair damaged tissues. When someone has a stroke, parts of their brain can be damaged, leading to various difficulties. Scientists are hopeful that by introducing these stem cells, they might be able to help the brain heal and recover. This particular study is in its very first phase, meaning it's the first time this treatment will be given to human volunteers. Because it's so new, the main aim is to carefully check if the treatment is safe for people and to understand how it behaves in the body.

It's important to know that because this is such an early study, we don't know yet if this treatment will actually improve stroke recovery. The focus right now is on safety. If it proves to be safe, then future studies will look at whether it can be effective. This research is a vital part of developing new ways to help people who have experienced a stroke, and it could lead to better treatments down the line. By taking part, volunteers are helping scientists learn incredibly important information.

Remember, this is a research study, and it's different from standard medical treatment. Taking part is a big decision, and it's always a good idea to discuss it thoroughly with your own doctor before considering joining any clinical trial.

Key takeaways

This is an early-stage study (Phase I) looking at a new stem cell treatment for stroke.
The main goal is to check if the treatment is safe for people to use.
It's open to adults (18+) who have had a stroke, both men and women.
Participants will have regular check-ups and monitoring.
Taking part means helping to advance medical understanding, but direct personal benefits are not guaranteed at this stage.
You can withdraw from the study at any time.

Who may be eligible?

This study is looking for volunteers who are adults, meaning you must be 18 years old or older. There is no upper age limit, so people of any adult age can consider taking part.

Both men and women are welcome to participate in this research. The most important condition for joining is that you have previously had a stroke. The study team will check your medical history to make sure you fit all the requirements.

Even if you meet these general points, there might be other specific health conditions or medications that mean you can't join. This is to ensure the study is as safe as possible for everyone involved. The research team will go through all the details with you if you're interested.

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.

Are you 18 years old or older?
Have you had a stroke?
Are you able to attend regular appointments for monitoring?
Are you a man or a woman? (Both sexes are welcome)

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would first have a full health check-up to make sure it's safe for you. The treatment involves receiving the special stem cells. As this is an early study, there will be a number of visits to the clinic or hospital, especially in the beginning, to closely monitor your health and see how your body reacts to the treatment. These visits will likely include physical examinations, blood tests, and possibly scans.

It's expected that you would need to be available for regular check-ups and follow-up appointments for a period after the treatment. The total duration of your involvement could range from several months to perhaps a year or more, depending on the study design and how closely you need to be monitored. All study-related costs, like appointments and treatments, are covered, but you should discuss travel costs. You'll be given a clear schedule of what's involved before you agree to anything.

Potential risks and benefits

Because this is an early-stage study (Phase I), the main benefit for you would be contributing to scientific knowledge and potentially helping develop new treatments for stroke in the future. As it's the first time this treatment is being given to humans, it's not known if it will directly improve your health condition, and the primary goal is to assess safety. Potential risks can include side effects from the stem cell treatment itself, such as pain, swelling, or infection where the cells are given. There could also be unexpected side effects that we don't yet know about. All medical procedures carry some risk, and the study team will explain all known and potential risks clearly. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual 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
France

Common questions

What is a 'stem cell'?

Stem cells are special cells in your body that can develop into many different types of cells, like nerve cells or muscle cells. Scientists are hopeful they could help repair damage.

What does 'Phase I' mean for a study?

Phase I means this is a very early stage of research. It's the first time the new treatment is given to people. The main goal is to check if it's safe and to see how your body handles it, rather than to see if it cures a condition yet.

Will this treatment cure my stroke?

At this early stage, we don't know if this treatment will cure or significantly improve stroke symptoms. The main focus is to understand its safety in people. Any potential benefits for stroke recovery would be explored in later studies if this one proves safe.

Do I have to pay to be in the study?

No, you do not have to pay to participate in the study. All study-related treatments, tests, and care will be provided at no cost to you. However, you should check about travel expenses.

Can I leave the study if I change my mind?

Yes, absolutely. You have the right to leave the study at any time, for any reason, without it affecting your current or future medical care. You just need to let the research team know.