Rare diseases
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A plain-language summary of the goals, design and what participants do
This clinical trial is focused on studying a condition known as refractory epilepsy, which is a type of epilepsy that does not respond well to standard treatments. The study also includes a specific form of epilepsy called Rasmussen Encephalitis, which is a rare, chronic inflammatory neurological disease. The treatment being tested in this trial is called AloCelyvir, which involves the use of special cells known as allogenic bone marrow-derived mesenchymal stem cells. These cells are modified in a laboratory setting to potentially help manage the condition.
The purpose of this study is to evaluate the safety and how well patients respond to this treatment. Participants in the trial will receive repeated doses of these stem cells through a method called intra-arterial infusion, which means the cells are delivered directly into the arteries. The study is designed for children and adolescents who have not had success with other epilepsy treatments. The trial will monitor participants over a period to observe any changes in their condition and to ensure the treatment is safe.
Throughout the study, researchers will be looking for any side effects that might occur from the treatment, as well as any improvements in the participants' epilepsy symptoms. The trial aims to provide new insights into managing refractory epilepsy and Rasmussen Encephalitis, potentially offering new hope for those affected by these challenging conditions.
The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.
4 criteria
7 criteria
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This is a type of epilepsy that does not respond to standard treatments and is believed to be caused by the immune system attacking the brain. It is characterized by frequent and severe seizures that are difficult to control. Over time, the condition can lead to persistent neurological symptoms due to ongoing inflammation and damage in the brain. The seizures can vary in type and severity, and they may occur without warning. The condition is chronic and requires ongoing management to address the symptoms and prevent further complications.
This is a rare, chronic inflammatory neurological disease that typically affects one hemisphere of the brain. It is characterized by frequent and severe seizures, loss of motor skills and speech, paralysis on one side of the body, and cognitive decline. The disease usually progresses over time, leading to significant neurological impairment. The inflammation in the brain is thought to be caused by an autoimmune response, where the body's immune system mistakenly attacks healthy brain tissue. The condition primarily affects children but can also occur in adults.
Other trials in this disease – keep exploring while you decide
Austria
The Netherlands
Czechia
France
Sweden
Belgiumsourced from the EU Clinical Trials Register and site verification
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