Dendritic cells therapy combined with immunomodulatory treatment in multiple sclerosis
This study is exploring a new treatment called TolDec for people with multiple sclerosis (MS). It’s a combination therapy, meaning it involves both a special type of cell therapy (dendritic cells) and other medicines that help control the immune system. The main goal is to see how well this new treatment can prevent new or growing MS lesions, which are damaged areas in the brain or spinal cord, as seen on MRI scans. Researchers will also be carefully checking for any serious side effects to make sure the treatment is safe. This is an early-stage study, known as 'Phase II', designed to learn more about how well the treatment works and its safety.
At a glance
What is this study about?
This research study is investigating a new approach to treating multiple sclerosis (MS). MS is a condition that affects your brain and spinal cord, often leading to problems with movement, sensation, and other body functions. The study is particularly interested in a treatment called TolDec, which brings together two different ways of fighting MS: a special type of cell therapy using 'dendritic cells' and other medications that help control the body's immune system.
The main aim of this study is to discover if this combination treatment can reduce the number of new or growing 'lesions' in people with MS. Lesions are areas of damage in the brain or spinal cord that are often seen on MRI scans. These lesions can cause MS symptoms, so reducing them is an important goal. The researchers will be counting these lesions at different points during the study to see if the treatment is making a difference.
Another very important part of this study is safety. The research team will be closely monitoring all participants for any side effects, especially serious ones. Taking part in a clinical trial means you'll be watched very carefully by medical professionals, and your health will be a top priority. This is an early-stage study (Phase II), meaning it's one of the first times this specific treatment combination is being tested in a larger group of people with MS, following initial safety checks.
Key takeaways
- This study is testing a new combination treatment called TolDec for MS.
- It aims to see if TolDec can reduce MS lesions and is safe for patients.
- The study involves special cell therapy and other immune-modifying medicines.
- Participants will have regular MRI scans to check for changes in MS lesions.
- This is an early-stage study (Phase II) focusing on effectiveness and safety.
Who may be eligible?
This study is looking for both men and women who are 18 years old or older to participate. There isn't an upper age limit mentioned, so people of many ages might be considered.
To join, you would need to have a confirmed diagnosis of multiple sclerosis. The study team will have specific medical criteria to decide who can take part, based on the type of MS you have and your current health status.
It's important to remember that even if you meet the basic age and sex requirements, there will be other medical checks to make sure the study is safe and suitable for you. Your doctor or the study team would be able to give you full details on whether you might be a good fit.
- Are you 18 years old or older?
- Do you have a diagnosis of multiple sclerosis (MS)?
- Are you able to attend regular appointments and have MRI scans?
- Are you comfortable with receiving an investigational (new) treatment?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
If you decide to take part in this study, you would receive the new treatment, TolDec, along with other specified medicines. This treatment involves a special cell therapy, which means there would likely be procedures to administer these cells. You would have regular appointments for medical check-ups, including physical examinations and blood tests.
Crucially, you would have several MRI scans throughout the study. These scans are essential to track any changes in your MS lesions. The study involves monitoring these lesions at specific times, such as at weeks 12, 18, and 24, to see if the treatment is working. Throughout the study, you would also be asked about any new symptoms or side effects you experience, and these would be carefully recorded.
The total duration of your participation in the core study would involve these regular assessments over several months. There would also be a period of follow-up after the main treatment phase to continue monitoring your health and any effects of the treatment.
Potential risks and benefits
Locations (1)
- —Spain
Common questions
What is multiple sclerosis (MS) and how does it happen?
MS is a condition where your immune system mistakenly attacks the protective covering of your nerves, making it difficult for your brain to communicate with the rest of your body.
What are 'lesions' in MS?
Lesions are areas of damage in the brain or spinal cord caused by MS. They are usually seen on MRI scans and can lead to MS symptoms.
What is TolDec therapy?
TolDec is the name of the new experimental treatment being tested in this study. It's a combination of a special cell therapy (dendritic cells) and other medicines for MS.
Is this a new treatment?
Yes, this is an investigational treatment. This study is an early stage (Phase II) clinical trial, meaning it's being tested to see if it's effective and safe in a larger group of people for the first time.
Will I get the actual treatment, or a placebo (dummy treatment)?
This study description doesn't mention a placebo. It focuses on evaluating the TolDec treatment combined with immunomodulatory treatment for its efficacy and safety.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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