Hand Transplantation for the Reconstruction of Below the Elbow Amputations
| Status: | Recruiting |
|---|---|
| Healthy: | No |
| Age Range: | 18 - 55 |
| Updated: | 5/5/2014 |
| Start Date: | September 2008 |
| End Date: | December 2022 |
| Contact: | Linda C. Cendales, M.D. |
| Email: | lcendal@emory.edu |
| Phone: | 404-727-0701 |
Organ transplantation has become the treatment of choice for most patients suffering end
stage diseases of the kidney, pancreas, liver, heart or lung.
Vascularized Composite Allotransplantation (VCA) {a.k.a. composite tissue
allotransplantation} is the term used to describe transplantation of multiple tissues (skin,
muscle, bone, cartilage, nerve, tendon, vessel) as a functional unit (e.g. hand). Several
recent advances in clinical organ transplant immunosuppression and experimental limb VCA
have now made it feasible to consider clinical VCA for the functional restoration of
patients with loss of one or both hands.
This protocol facilitates the development of limb VCA at the Atlanta Veterans Affairs
Medical Center (VAMC) and at Emory University for patients with below the elbow amputations.
It will evaluate the patients' use of transplanted limb(s) in activities of daily living and
compare the function of the transplanted hand to the function with their previous
prosthesis.
Patients with below the elbow amputations will be enrolled. Donor tissue will be recovered
from deceased donors following the guidelines of and in cooperation with the regional Organ
Procurement Organization. The transplantation procedure and postoperative care will be
performed using the standard technique for limb replantation. Patients will receive standard
immunosuppressive regimen. Rejections will be treated in keeping with experience from the
solid organ transplant experience. Graft failure will be treated with allograft amputation.
stage diseases of the kidney, pancreas, liver, heart or lung.
Vascularized Composite Allotransplantation (VCA) {a.k.a. composite tissue
allotransplantation} is the term used to describe transplantation of multiple tissues (skin,
muscle, bone, cartilage, nerve, tendon, vessel) as a functional unit (e.g. hand). Several
recent advances in clinical organ transplant immunosuppression and experimental limb VCA
have now made it feasible to consider clinical VCA for the functional restoration of
patients with loss of one or both hands.
This protocol facilitates the development of limb VCA at the Atlanta Veterans Affairs
Medical Center (VAMC) and at Emory University for patients with below the elbow amputations.
It will evaluate the patients' use of transplanted limb(s) in activities of daily living and
compare the function of the transplanted hand to the function with their previous
prosthesis.
Patients with below the elbow amputations will be enrolled. Donor tissue will be recovered
from deceased donors following the guidelines of and in cooperation with the regional Organ
Procurement Organization. The transplantation procedure and postoperative care will be
performed using the standard technique for limb replantation. Patients will receive standard
immunosuppressive regimen. Rejections will be treated in keeping with experience from the
solid organ transplant experience. Graft failure will be treated with allograft amputation.
This protocol will study patients with below the elbow amputations who are selected to
undergo limb allotransplantation. We will study patients after they have been trained on the
use of a prosthetic limb device prior to transplantation. We will treat them with
immunosuppression known to prevent the rejection of other allografted tissues and designed
to minimize their dependence on chronic maintenance immunosuppression. These patients will
be studied to determine whether the transplanted limb functions better, worse or the same as
a prosthetic hand, and to quantify those differences
undergo limb allotransplantation. We will study patients after they have been trained on the
use of a prosthetic limb device prior to transplantation. We will treat them with
immunosuppression known to prevent the rejection of other allografted tissues and designed
to minimize their dependence on chronic maintenance immunosuppression. These patients will
be studied to determine whether the transplanted limb functions better, worse or the same as
a prosthetic hand, and to quantify those differences
Inclusion Criteria:
- male or female, 18-55 years of age, with below elbow amputation
- ability to give informed consent
Exclusion Criteria:
- Any condition that precludes serial follow-up.
- Any active malignancy or any history of a hematogenous malignancy or lymphoma.
Patients with primary, cutaneous basal cell or squamous cell cancers may be enrolled
providing these are appropriately eliminated prior to transplant. For amputations due
to malignancy, 5 years recurrence free survival will be required prior to enrollment.
- Any known immunodeficiency syndrome.
- Inability or unwillingness to comply with protocol monitoring and therapy, including,
among others, a history of noncompliance, circumstances where compliance with
protocol requirements is not feasible due to living conditions, travel restrictions,
access to urgent medical services
- Pregnancy or unwillingness to practice birth control methods during the first year of
the study.
- Unwillingness to undergo blood transfusion if clinically indicated
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