DEVELOPMENT OF INNOVATIVE TARGETED LIPOSOMAL FORMULATIONS FOR THE TREATMENT OF INFLAMMATORY DRIVEN PULMONARY FIBROSIS
试验速览
- 阶段
- 不适用
- 状态
- 进行中(未招募)
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- liposome characterization and bio-nano interaction
研究概览
简要总结
The study aims to develop an innovative nano-platform for the treatment of lung fibrogenic disorders (LFD). The approach involves local delivery by inhalation of drug-loaded liposomes, coated with hyaluronic acid (HA) to directly target CD44+ pathogenic cells. We aim to expand and develop the formulation "XHALIP¿ (patent pending) by the following steps: 1) Characterization of safety and bioavailability in healthy and lung fibrogenic disorders (LFD) mice; 2) Evaluation of the pharmacokinetics and uptake by human LFD fibroblasts and macrophages and on healthy/LFD mice; 3) testing of antifibrotic/-inflammatory activities of the most promising XHALIP on mouse LFD models and translational studies on lung cells/tissues from LFD patients AIM 1: XHALIP characterization and bio-nano interaction AIM 2: Organ and cell lung Targeting AIM 3: Efficacy assessment in lung fibrosis models
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosis of pulmonary fibrotic conditions (idiopathic, Connective Tissue Disease Associated)
排除标准
- •Unwilling to provide informed consent
结局指标
主要结局
liposome characterization and bio-nano interaction
时间窗: 12 months
次要结局
未报告次要终点
研究者
Veronica Codullo
MD PhD
Fondazione IRCCS Policlinico San Matteo di Pavia
