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临床试验/NCT01853111
NCT01853111已完成1 期

Biomarker-guided Withdrawal of Immunosuppression in Recipients of Vascularized Composite Tissue Transplants

Brigham and Women's Hospital2 个研究点 分布在 1 个国家目标入组 1 人开始时间: 2014年3月1日最近更新:
适应症

试验速览

阶段
1 期
状态
已完成
入组人数
1
试验地点
2
主要终点
Complete cessation of immune suppression without evidence of rejection for more than 6 months.

研究概览

简要总结

Many patients suffer from devastating injuries to vascularized composite tissues. Vascularized composite tissues are blocs of functional tissue that can contain multiple tissue types such as bone, muscle, nerves, blood vessels, tendons, ligaments, and others. Examples of patients with severe vascularized composite tissue defects include limb amputees, patients with third-degree burns to the face or extremities, soldiers with improvised-explosive-device blast injuries to the face, and others. These patients cannot be helped satisfactorily with conventional reconstructive surgery; however, recently vascularized composite allotransplantation (VCA) such as transplantation of faces and limbs became available to this patients. Unfortunately, at this juncture, patients who receive VCA must submit to life-long regime of immunosuppressant drugs with serious side effects such as infection, renal toxicity and cancer. Immune tolerance is the absence of a destructive immune response from the recipient's body to the transplant, while otherwise maintaining sufficient immune function to fight infections and other threats. Transplant recipients with immune tolerance do not need to take immunosuppression drugs. The investigators believe that they can achieve immune tolerance in recipients of face and limb transplants.

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 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • adults who have received VCA transplants at Brigham and Women's Hospital
  • no less than 3 months elapsed since VCA transplant,
  • on steroid-free immune dual immunosuppression with tacrolimus (6-8 ng/ml trough levels) and mycophenolate mofetil,
  • no current concerns of rejection

排除标准

  • recent (<3 months) episodes of rejection,
  • active bacterial or viral infection,
  • malignancy,
  • non-healing wounds
  • pregnancy

结局指标

主要结局

Complete cessation of immune suppression without evidence of rejection for more than 6 months.

时间窗: 6 -24 months

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Bodhan Pomahac

Director, Plastic Surgery Transplantation

Brigham and Women's Hospital

研究点 (2)

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