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用于多肢截肢的血管化复合同种异体移植

2026年9月29日 更新者:Simon George Talbot、Brigham and Women's Hospital

Limb transplantation surgery is the transfer of one or more limbs from a deceased human donor to a patient with single or multiple limb amputation. Hand transplantation is an innovative reconstructive procedure that has the potential to significantly improve the lives of hand amputees. The purpose of this study is to develop the best practices for multiple limb transplantation that will improve the outcomes of future limb transplant recipients.

研究概览

地位

招聘中

详细说明

Limb transplantation surgery, the transfer of the limb(s) from a deceased human donor to a patient with amputation of one or more limbss, is an experimental reconstructive procedure that has the potential to significantly improve the lives of amputees.

Limb transplantation is similar to face transplantation in that the tissues transplanted include skin, tendons, muscles, ligaments, bones and blood vessels. The transplant team at Brigham and Women's Hospital includes a wide variety of medical and surgical specialties. The team hopes to build upon the success of their first face transplantation to provide amputee patients with the significant benefits of limb transplantation.

Toward this goal, BWH is actively seeking qualified candidates for the limb transplant research study. We will be studying a small group of people to learn more about:

  • How to advance the science of limb transplantation
  • How to support and limit transplant rejection issues
  • How people do after limb transplantation

We describe limb transplant surgery as a life-giving procedure because it has the potential to dramatically improve, that is to restore, both a patient's mental and physical health and his/her ability to function and integrate in society. However, as with any other type of organ transplantation, this improvement will require the patient to make a lifetime commitment to taking medications that suppress the body's immune system.

Conventional reconstruction methods are always considered first, but they may provide less than optimal results for certain patients. There are many sophisticated prostheses that satisfactorily replace the basic function of a missing limb. However, replacing limbs (in whole or in part) with prosthetics remains suboptimal in that prostheses do not provide sensation and do not have a natural appearance. Limbtransplant surgery, however, has the potential to deliver these desired functional and aesthetic benefits. Functionally, limb transplant surgery can provide a patient with new limbs that, after extensive rehabilitation, allow him/her to perform daily activities and, in most cases, return to work. Furthermore, the ability to restore a near-normal aesthetic appearance of the limb(s) can lead to tremendous psychological benefits, including elevated confidence and mood.

From the time we begin our search for a qualified limb transplant recipient to the continuing care we provide following surgery, a significant amount of time, expertise and attentiveness is contributed toward making the procedure a progressive success. Limb transplant candidates go through an extensive screening process that is likely to last several months. This screening includes a psychiatric and social support evaluation and a series of imaging tests to help determine a patient's physical and mental readiness for the procedure. If, upon completion of the screening process, it is determined that a patient is a suitable candidate, we will place the patient on a transplant waiting list. We will then begin working with the New England Organ Bank (NEOB) team to find a donor who matches the recipient's tissue requirements - for example similar age and correct blood type. This search could take many months, and, if a suitable donor is not found within one year, we will speak with the patient to determine whether he/she is willing to continue waiting.

研究类型

介入性

注册 (估计的)

10

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Massachusetts
      • Boston、Massachusetts、美国、02115
        • 招聘中
        • Brigham and Women's Hospital
        • 首席研究员:
          • Simon Talbot, M.D.
        • 接触:

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 60年 (成人)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Age between 18 and 60 years.
  • Single dominant hand or multiple limb amputation.
  • Time elapsed since amputation more than 6 months but less than 15 years.
  • Patient has tried prosthesis without success.
  • Level of amputation anywhere from the wrist (or ankle) joint to just below the shoulder (or hip) joint, which should be functional.
  • Signed written informed consent.
  • Willing to complete psychological and social evaluations.
  • Willing to take immunosuppressants - drugs that help prevent rejection of the transplant - for life.
  • Willing to comply with extensive post-transplant rehabilitation for a minimum of two years.
  • Willing to return for follow-up visits as determined by the treating physician.
  • Willing to receive standard vaccinations prior to the transplant, such as influenza and hepatitis B.

Exclusion Criteria:

  • Single, non-dominant hand amputees.
  • Active malignancy.
  • High risk of return of malignancy.
  • History of persistent non-compliance.
  • Findings of psychological evaluation that indicate inability to comply with physician's orders or mental instability.
  • Any diagnosis that puts the subject at risk from limb transplant surgery or life-long immune suppression.
  • Inability to ensure adequate follow-up of post-transplant care and immune suppression.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:不适用
  • 介入模型:单组作业
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的:Transplantation

Subjects will undergo single or multiple limb transplantation

其他名称:
  • 血管化复合同种异体移植

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Outcomes of limb transplantation
大体时间:Subjects will be followed for 18 months after transplantation

We will undertake an objective evaluation of the results of limb transplantation in an "outcome-oriented" study

Subjects will be followed for 18 months after transplantation

次要结果测量

结果测量
措施说明
大体时间
Efficacy and optimization of the immune suppression protocol
大体时间:18 months

We will evaluate the risks of rejection or likelihood of tolerance induction by measuring specific parameters in the blood or tissue, including: Serum alloantibodies concentration, numbers/phenotype of specific T cell alloreactivity in the peripheral blood, phenotypic characterization of graft infiltrating cells and local gene expression of cells and cytokines.

18 months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2010年2月1日

初级完成 (估计的)

2030年12月31日

研究完成 (估计的)

2030年12月31日

研究注册日期

首次提交

2011年2月9日

首先提交符合 QC 标准的

2011年2月9日

首次发布 (估计的)

2011年2月10日

研究记录更新

最后更新发布 (实际的)

2026年10月1日

上次提交的符合 QC 标准的更新

2026年9月29日

最后验证

2026年9月1日

更多信息

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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