Vascularized Composite Allotransplantation for Multiple Extremity Amputations
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Outcomes of limb transplantation
研究概览
简要总结
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.
详细描述
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.
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
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Outcomes of limb transplantation
时间窗: 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
次要结局
- Efficacy and optimization of the immune suppression protocol(18 months)
研究者
Simon George Talbot
Director, Upper Extremity Transplant Program
Brigham and Women's Hospital