2024-520427-86-00RecruitingPhase 1
Phase I, open-label clinical trial to evaluate the safety and clinical response of repeated-dose intra-arterial infusion of autologous mesenchymal cells in children and adolescents with refractory epilepsies.
Source: EU CTIS (euclinicaltrials.eu) · Last updated 24 Jan 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
To assess the safety and tolerability of intra-arterial administration of autologous mesenchymal stem cells in patients with immune-mediated refractory epilepsies.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 10 (estimated)
- First submitted
- 24 Jan 2025
- Start date
- 24 Jan 2025
- Lead sponsor
- Fundacion Para La Investigacion Biomedica Del Hospital Universitario La Princesa
- Diseases
- Epilepsy
- EU CT number
- 2024-520427-86-00
- EudraCT number
- 2021-003607-17
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 10
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
AI-kivonat: who the study is looking for
Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for children and adolescents whose epilepsy is caused by the immune system and has not improved with standard treatment.
- Age
- Under 16 years of age (the record also lists a maximum age of 17 years).
- Sex
- All sexes can join.
- Disease stage
- Epilepsy of immune cause that has not responded to first or second line treatment, with movement and/or thinking problems. A special group is people having epilepsy surgery because of Rasmussen's Encephalitis.
- Earlier treatment
- Must have had first or second line treatment (antiepileptic drugs and usual immune-modulating therapy) without enough benefit.
Main reasons for not taking part
- Active infection of the brain or body
- Active tumour or active chemotherapy
- Heart disease, dementia or other degenerative brain disease
- Cannot have a catheter placed in an artery (for example difficult artery access or blood clotting problems)
- Frequent bad reactions or clot complications linked to blood products
Read by machine on 9 Nov 2026.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Concomitant illnesses that may affect patient safety or outcome such as: - Active CNS or systemic active infections - Active tumour - Active chemotherapy - Cardiac disease - Dementia or other degenerative CNS disease
Other illness
- Any condition in which catheterisation of the arterial system is contraindicated or not feasible (major behavioural disorders preventing adequate collaboration, difficult arterial access or clinically relevant coagulation parameters).
- Any condition where therapeutic products cannot be administered (history of frequent adverse reactions or thromboembolic complications associated with blood components).
Other
- Refusal of the patient or family members to adequate follow-up.
Who the study is looking for
- Acceptance of informed consent.
- Paediatric population under 16 years of age.
- Epilepsy of immune etiology refractory to first or second line treatment (antiepileptic drugs and conventional immunomodulatory therapy) in which motor and/or cognitive impairment is observed. A special group will be those undergoing epilepsy surgery in the context of Rasmussen's Encephalitis.
- Possibility of performing CMR, electrophysiological tests, PET and neuropsychological evaluations.
Age in the registry: - to 17 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital Infantil Universitario Nino Jesus | Madrid | Spain | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.