2024-520427-86-00招募中1 期
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.
Fundacion Para La Investigacion Biomedica Del Hospital Universitario La Princesa1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2025年1月24日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- To measure dose-limiting toxicities (DLTs, defined in the protocol as MSC infusion-related grade 3 toxicities occurring in the first 28 days of treatment).
研究概览
简要总结
To assess the safety and tolerability of intra-arterial administration of autologous mesenchymal stem cells in patients with immune-mediated refractory epilepsies.
入排标准
- 年龄范围
- 0 years 至 17 years（0-17 Years）
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
To measure dose-limiting toxicities (DLTs, defined in the protocol as MSC infusion-related grade 3 toxicities occurring in the first 28 days of treatment).
To measure dose-limiting toxicities (DLTs, defined in the protocol as MSC infusion-related grade 3 toxicities occurring in the first 28 days of treatment).
次要结局
- To asses clinical response
研究者
Gina Paola Mejía Abril
Scientific
Fundacion Para La Investigacion Biomedica Del Hospital Universitario La Princesa
研究点 (1)
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