Identification of Non-gal, Non-HLA Antigens in Patients Implanted With Xenogenic Material
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 197
- 试验地点
- 3
- 主要终点
- Identify Non-gal, non-HLA protein antigens in patients that have received xenogenic tissue implant.
研究概览
简要总结
This study involves collecting serum samples from patients presenting for aortic valve replacement at Mayo Clinic, Rochester, MN. Serum samples will be collected pre-op, between 2 weeks and 3 months, between 3-11 months (optional), and between 12-18 months post-operatively. The patients antibodies in these serum samples will be used to capture proteins from the same type of tissue their replacement heart valves are made from (i.e., bovine/porcine pericardium - a non-human tissue which is currently used to make glutaraldehyde-fixed heart valves). The captured proteins will be identified, and compared over time (i.e., 0, 1, 3 and 12 months) to determine which proteins (i.e., antigens) in bovine/porcine pericardium that the patient is mounting an immune response towards.
详细描述
Protein G HP SpinTrap columns will be used to capture IgG antibodies from patient serum pre-implant, between 2 weeks-3 months, between 3-11 months and between 12-18 months post-implant. These antibodies will be cross-linked to the column and then protein extracted from implant tissue (ie Native bovine/porcine pericardium) will be deglycosylated and run through the column. Antigenic proteins will be trapped and non-antigenic proteins will be washed through the column. These antigenic proteins will be eluted off the column and identified using LC-MS/MS. The proteins identified in the pre-implant elutant will be compared to the proteins in post-implant elutant to identify xenoantigens. Success criteria will be method validation by identification of previously known and new currently unknown xenoantigens.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients who will receive either a biological or mechanical heart valve
排除标准
- •Currently receiving therapy for cancer requiring treatment with concurrent radiotherapy and/or chemotherapy
- •Cancer in remission for less than 5 years if previously treated with radiotherapy and/or chemotherapy
- •Previous tissue valve implants
- •Current pregnancy
结局指标
主要结局
Identify Non-gal, non-HLA protein antigens in patients that have received xenogenic tissue implant.
时间窗: Approximately 12-18 months post-operatively
The captured proteins will be identified, and compared over time (i.e., pre-op, between 2 weeks and 3 months, between 3-11 months (optional), and 12-18 months post-operatively) to determine which proteins (i.e., antigens) in bovine/porcine pericardium that the patient is mounting an immune response towards.
次要结局
未报告次要终点
研究者
Leigh G. Griffiths
Associate Professor of Medicine
Mayo Clinic