Status:
COMPLETED
Withdrawal of Immunosuppression in Recipients of Face and Extremity Transplants
Lead Sponsor:
Brigham and Women's Hospital
Collaborating Sponsors:
Beth Israel Deaconess Medical Center
Conditions:
Vascularized Composite Allotransplantation
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
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, mus...
Eligibility Criteria
Inclusion
- 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
- recent (\<3 months) episodes of rejection,
- active bacterial or viral infection,
- malignancy,
- non-healing wounds
- pregnancy
Key Trial Info
Start Date :
March 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 10 2020
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT01853111
Start Date
March 1 2014
End Date
March 10 2020
Last Update
January 27 2021
Active Locations (1)
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1
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115