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.
Key facts
- Where
- Madrid, SpanyolországSee the site
- Phase
- 1. fázis
Where in Spanyolország
- Hospital Infantil Universitario Nino JesusMadrid, SpanyolországTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Fundacion Para La Investigacion Biomedica Del Hospital Universitario La Princesa
- Trial code
- EU 2024-520427-86-00
- Record updated
- 2025. január 24.
- Original description
To assess the safety and tolerability of intra-arterial administration of autologous mesenchymal stem cells in patients with immune-mediated refractory epilepsies.Read full original descriptionShow less
To assess the safety and tolerability of intra-arterial administration of autologous mesenchymal stem cells in patients with immune-mediated refractory epilepsies.
Inclusion: 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.
Exclusion: 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; 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); Refusal of the patient or family members to adequate follow-up.