Authorised Human Pharmacology (Phase I)- First administration to humans Autoimmune refractory epilepsy and Rasmussen Encephalitis

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.

EU CTIS ID: 2024-520427-86-00

What this study is testing

To assess the safety and tolerability of intra-arterial administration of autologous mesenchymal stem cells in patients with immune-mediated refractory epilepsies.

  • Human Pharmacology (Phase I)- First administration to humans

A plain-language read of the study's public EU CTIS listing. The study team confirms the details.

Who can take part

You may be able to join if

  • 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.

You likely can't join if

  • 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.

The study team makes the final eligibility decision.

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 0-17 years. The study team makes the final eligibility decision.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.