Search Tolerance Signature in Vascularised Composite Allograft
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- Biomarkers of molecular signature from operational tolerance and/or chronic rejection research
研究概览
简要总结
Composite tissue allotransplants (CTA) involve transplantation of various tissues including vessels, nerves, skin, bones, and immune cells and entail a significant antigenic load. The large majority of recipients have been maintained on immunosuppression therapy similar to that used in solid organ transplantation that is associated with the complications usually reported in solid organ transplantation. The question whether risks associated with indefinite immunosuppressive are justified for a non-lifesaving procedure still remains unanswered. At present no CTA recipient proved to be spontaneously tolerant with any immunosuppressive protocol; indeed, until now all recipients who discontinued the immunosuppressive therapy rejected their graft. On the other hand CTA recipients showed a low incidence of chronic rejection despite the high incidence of acute rejection episodes.
For all these reasons it should be of great interest to minimize the immunosuppression in CTA patients knowing their immunologic "risk". The main outcome of this study is to search for the signature of tolerance in recipients of hand or face allotransplantation testing biomarkers previously identified in operational tolerant kidney transplant recipients.
These markers have been developed studying tolerant kidney recipients and they were already tested in five bilateral hand transplantations and one face transplantation.
The present study will include hand and face allograft recipients transplanted at least one year in several European institutions (Innsbruck, Lyon, Monza, Valencia): 11 bilateral hand transplantations, 4 single hand transplantations and 3 face transplantations. All the patients will undergo B cell phenotyping, TCR repertoire, molecular signature from operational tolerance and a skin biopsy with immunohistochemical staining of the specimens in order to show signs of acute or chronic rejection.
The results could provide a valid tool to detect operationally tolerant recipients as well as recipients prone to develop chronic rejection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
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
- •Patient with Hand (unilateral/bilateral) or face allotransplantation for at least one year
- •Patient without clinical sign of acute rejection at inclusion
- •Patient who signed the informed protocol consent
- •Patient older than 18 years old
- •Patient covered by an health insurance
- •Patient without legal protection
排除标准
- •Patient with Hand or face allotransplantation for less than one year
- •Patient with clinical sign of acute rejection at inclusion
- •Unsigned protocol consent
- •Patient under the age of 18 years old
结局指标
主要结局
Biomarkers of molecular signature from operational tolerance and/or chronic rejection research
时间窗: 1 day
B cell phenotyping, TCR repertoire, molecular signature from operational tolerance
次要结局
- Pathological characteristics of skin acute/chronic rejection on skin biopsy(1 day)
- Phenotype of skin T lymphocyte in cutaneous biopsies(1 day)