Human Upper Extremity (Hand and Forearm) Allotransplantation (NCT00722280) | Clinical Trial Compass
TerminatedNot Applicable
Human Upper Extremity (Hand and Forearm) Allotransplantation
Stopped: loss of funding
United States38 participantsStarted 2008-12
Plain-language summary
Overall Goal
To establish hand transplantation as a safe and effective reconstructive strategy for the treatment of upper extremity amputations.
Specific Aim
To reduce the risk of rejection and enable allograft survival while minimizing the requirement for long term high dose immunosuppression.
For this purpose, we propose to utilize the "Pittsburgh Protocol", which is an immunomodulatory strategy that has been implemented in solid organ transplants at UPMC. Early results in living related liver and kidney patients have confirmed that this protocol provides the means to allow graft survival with minimization of maintenance immunosuppression and even allows weaning of some patients from long-term immunosuppression.We hypothesize that a similar protocol can enable graft survival in highly immunogenic composite tissue allografts like hand transplants while reducing the number,dosing and/or frequency of immunosuppressive drugs associated with serious adverse effects.
Who can participate
Age range18 Years – 60 Years
SexALL
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Inclusion criteria
✓. Age (\>18 years \<60 years): Recipients \<18 years of age are excluded due to limitations of giving full informed consent and the potentially increased risk of lymphoproliferative disorder in a younger population. Once hand transplantation and in particular the strategy for minimizing immunosuppression has proven to be efficacious and safe, the restrictions with regard to recipient age may be relaxed.
✓. No serious co-existing medical (coronary artery disease, diabetes) or psycho-social problems (including alcoholism, drug abuse).
✓. Must be negative for malignancy (for 10 years) or HIV (at transplant).
✓. Negative crossmatch with donor.
✓. Negative pregnancy test in female recipient of child bearing potential and consent to use reliable contraception for at least one year following transplantation.
✓. Consent to cell collection, storage, and bone marrow infusion as part of the treatment regime.
✓. Amputation may be recent (acute injury) or remote (patient may have undergone rehabilitation with prostheses).
. Conditions that may impact the immunomodulatory protocol: These include diseases like HIV or malignancy that could expose the recipient to an unacceptable risk under immunosuppressive treatment. Sensitized recipients with high level of preformed antibodies are also at risk.
✕. Conditions that may impact the success of the surgical procedure or increase the risk of postoperative complications: These include inherited coagulopathies like Hemophilia, Von-Willebrand's disease, Protein C and S deficiency, Thrombocythemias, Thallassemias, Sickle Cell disease etc. Mixed connective tissue diseases and collagen diseases can result in poor wound healing after surgery,
✕. Conditions that may impact functional outcomes: Lipopolysaccharidoses and amyloidosis are few of the conditions that may impact nerve regeneration and impair outcomes. Also, rare disorders of bone healing like osteopetrosis may also be causes for exclusion.