Fibrin Gel Loaded with Extracellular Vesicles for the Treatment of Cartilage Lesions in the Joints - GelVex Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 51
- 试验地点
- 1
- 主要终点
- Confirm the incorporation rate of extracellular vesicles (EV) into platelet-rich plasma (PRP) following the formation of fibrin gel
研究概览
简要总结
This project aims to produce and study in vitro/ex vivo a platelet rich plasma (PRP)-derived fibrin gel loaded with mesenchymal stromal cells (MSC)-extracellular vesicles (EVs), to combine the positive results on cartilage growth of PRP growth factors and the hyaline cartilage stimulating activity of MSC-EVs. Therefore, the project goal is to provide an advanced option for orthopedic patients with an innovative evolution of a gold standard procedure, making it easy to translate into daily clinical practice for physicians, healthcare professionals and patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •males and females ≥ 18
- •patients undergoing plastic surgery procedures;
- •patients undergoing elective joint surgery with a diagnosis of knee or hip osteoarthritis (any Kellgren-Lawrence grade);
- •patients undergoing regenerative medicine treatments with PRP with a diagnosis of knee or hip osteoarthritis (any Kellgren-Lawrence grade;
- •signed Informed Consent for the study
排除标准
- •Positive virological test (HIV, HCV, HBV, TPHA)
- •Pregnancy or breastfeeding by self-declaration
- •Other conditions that, at the discretion of the investigator or the physician
结局指标
主要结局
Confirm the incorporation rate of extracellular vesicles (EV) into platelet-rich plasma (PRP) following the formation of fibrin gel
时间窗: 2 years
To implement the preliminary data obtained by the PI in the development of a protocol to achieve efficient incorporation of mesenchymal stem cell-derived extracellular vesicles into platelet-rich plasma-derived fibrin gels and characterize their release. MSC-EVs will be embedded in fibrin gel using PRP provided by patients enrolled in the study that is activated to obtain the solid form. To monitor the incorporation and release of EVs from the PRP-gel, EVs will be labeled with a fluorescent marker to allow their subsequent detection by cytometry or imaging methods. The ability of the released EVs to be incorporated into human chondrocytes and penetrate cartilage will be tested using three in vitro models: i) flow cytometry in a 2D culture model; ii) a 3D microfluidic model; iii) a Quantitative Imaging with cartilage explants. Biological activity will be tested on pathological chondrocytes.
次要结局
未报告次要终点