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Taking people in SpainPhase 1

Tests repeated infusions of a patient's own stem cells for hard-to-control seizures in children

Tests a patient's own stem cells in children with hard-to-control seizures from immune-related epilepsy.

Key facts

Who runs it
Fundacion Para La Investigacion Biomedica Del Hospital Universitario La Princesa
Where
Madrid, SpainSee the site
Registry title
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.
Status
Recruiting
Phase
Phase 1
People taking part
10 people, planned
Started
24 Jan 2025
Expected to end
31 Dec 2027
Type of study
Interventional
Record updated
24 January 2025

Who can take part

AI summary

From the trial's eligibility criteria. 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

The registry criteria, word for word

Show all 8 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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

Where in Spain

  • Hospital Infantil Universitario Nino JesusMadrid, SpainTaking people

About the trial

What the trial wants to find out

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

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record

Print a page for my doctor

Data and sources

Registry record
Listed on the EU's official list of trials (CTIS).
Official title
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.
Plain-language title
Tests repeated infusions of a patient's own stem cells for hard-to-control seizures in childrenGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 9 November 2026.
Record updated
24 January 2025