Autologous Thymus Transplant in CHD Patients With no Congenital Athymia - A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 10
- 主要终点
- Rate of Complications from Autologous Thymus Reimplantation
研究概览
简要总结
This pilot study will look at whether putting back a child's own thymus tissue during heart surgery is safe and may help support the immune system in children with congenital heart disease (CHD). During some heart surgeries, the thymus gland is removed to allow surgeons access to the heart. The thymus is important for helping the body develop infection-fighting immune cells.
Researchers will compare children who have their thymus tissue reimplanted with children who have the thymus removed but not reimplanted. The study will evaluate the safety of the procedure, whether the transplanted tissue survives and functions, and whether it helps maintain or improve immune system health. Researchers will also monitor infections, recovery after surgery, hospital stays, quality of life, and overall health outcomes. Blood samples will be collected over time to better understand how the immune system changes after surgery and whether thymus reimplantation provides long-term benefits. Participants will be followed for up to 24 months after surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 2 Months 至 2 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Infants diagnosed with CHD requiring their first cardiac surgery through a sternotomy.
- •Age: 2 months to 2 years old at time of cardiac surgery.
- •Parents or legal guardians have provided informed consent.
排除标准
- •Patients with previous cardiac surgery through a sternotomy.
- •Patients with a planned partial thymectomy.
- •Patients with congenital athymia or thymic atrophy.
- •Known severe immunodeficiency unrelated to thymus function.
- •Presence of severe non-cardiac congenital anomalies.
- •Parent or guardians who refuse to consent.
研究组 & 干预措施
Surgical Intervention
干预措施: Autologous Thymus Transplant (Procedure)
结局指标
主要结局
Rate of Complications from Autologous Thymus Reimplantation
时间窗: Within 30 days after surgery
Proportion of participants experiencing one or more thymus reimplantation-related postoperative complications (e.g., surgical site infection, bleeding requiring transfusion, thromboembolic events, or unplanned return to the operating room).
Rate of Success of Thymus Reimplantation
时间窗: Baseline, 6 months, and 12 months after surgery
Evidence of immune reconstitution based on T-cell counts, recent thymic emigrants (TREC assays), T-cell repertoire diversity, and T-cell functional assessments.
Number of Enrolled Participants
时间窗: From enrollment to the end of treatment (approximately 24 months).
Percentage of eligible patients who enroll in the study compared with those approached and eligible.
次要结局
- Incidence of Postoperative Infections(Within 12 months after surgery)
- Length of Hospital Stay(Total number of days spent in the hospital from surgery to discharge assessed up to 30 days post-surgery.)
- Number of Participants with Postoperative Complications(Within 12 months after surgery.)
- Change from Baseline in Pediatric Quality of Life Inventory (PedsQL) Total Score(12 months after surgery.)
- Rate of Overall Survival(24 months after surgery)
- Change From Baseline in Immune-Related Gene Expression Levels(Baseline and 1, 3, 6, 12, and 24 months after surgery.)
- Change From Baseline in T-cell, B-cell, and NK-cell Subset Frequencies(Baseline and 1, 3, 6, 12, and 24 months after surgery)
- Change From Baseline in Immune Cell Functional Assay Results(Baseline and 1, 3, 6, 12, and 24 months after surgery.)