Withdrawal of Immunosuppression in Recipients of Face and Extremity Transplants
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ClinicalTrials.gov Identifier: NCT01853111 |
Recruitment Status :
Completed
First Posted : May 14, 2013
Last Update Posted : January 27, 2021
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Vascularized Composite Allotransplantation | Biological: Interleukin-2 | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 1 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Biomarker-guided Withdrawal of Immunosuppression in Recipients of Vascularized Composite Tissue Transplants |
Actual Study Start Date : | March 1, 2014 |
Actual Primary Completion Date : | December 20, 2019 |
Actual Study Completion Date : | March 10, 2020 |
Arm | Intervention/treatment |
---|---|
Experimental: Interleukin 2
Subjects who receive a tolerogenic drug protocol
|
Biological: Interleukin-2
Other Name: Aldesleukin, proleukin |
- Complete cessation of immune suppression without evidence of rejection for more than 6 months. [ Time Frame: 6 -24 months ]

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Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01853111
United States, Massachusetts | |
Brigham and Women's Hospital | |
Boston, Massachusetts, United States, 02115 |
Principal Investigator: | Bohdan Pomahac, MD | Brigham and Women's Hospital |
Responsible Party: | Bodhan Pomahac, Director, Plastic Surgery Transplantation, Brigham and Women's Hospital |
ClinicalTrials.gov Identifier: | NCT01853111 |
Other Study ID Numbers: |
2012P001539 |
First Posted: | May 14, 2013 Key Record Dates |
Last Update Posted: | January 27, 2021 |
Last Verified: | January 2021 |
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