Withdrawal of Immunosuppression in Recipients of Face and Extremity Transplants
| Status: | Active, not recruiting |
|---|---|
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 7/21/2018 |
| Start Date: | March 2014 |
| End Date: | April 2019 |
Biomarker-guided Withdrawal of Immunosuppression in Recipients of Vascularized Composite Tissue Transplants
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.
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.
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
We found this trial at
1
site
75 Francis street
Boston, Massachusetts 02115
Boston, Massachusetts 02115
(617) 732-5500
Principal Investigator: Bohdan Pomahac, MD
Brigham and Women's Hosp Boston’s Brigham and Women’s Hospital (BWH) is an international leader in...
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