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


Phase 1
18 Years
65 Years
Not Enrolling
Both
Transplantation of Vascularized Composite Tissues Such as Face or Limbs

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Trial Information

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


Inclusion Criteria:



- 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

Exclusion Criteria:

- recent (<3 months) episodes of rejection,

- active bacterial or viral infection,

- malignancy,

- non-healing wounds

- pregnancy

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:

6 -24 months

Safety Issue:

No

Authority:

United States: Food and Drug Administration

Study ID:

2012P001539

NCT ID:

NCT01853111

Start Date:

May 2013

Completion Date:

Related Keywords:

  • Transplantation of Vascularized Composite Tissues Such as Face or Limbs

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