Clinical Trial: Human Upper Extremity (Hand and Forearm) Allotransplantation
Study Status: Enrolling by invitation
Recruit Status: Enrolling by invitation
Study Type: Interventional
Official Title: The Pittsburgh Protocol in Human Upper Extremity Allotransplantation
Brief 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.
Detailed Summary:
Suitable candidates will be identified via patient information brochures and via advertisements directed at upper limb amputees. For this purpose, a web-page will be constructed for free access by interested individuals. This website will be accessible through standard search engines. Interested potential subjects will be instructed to contact the investigator for an appointment. At the time of appointment, candidates will be first requested to complete a screening consent form (SCF) before undergoing further evaluation/medical screening procedures. The SCF includes a written consent to obtain PHI of the candidate. When the candidate visits UPMC he will undergo a consultation with the PI who will perform a thorough clinical assessment and explain in detail the treatment options, risks and benefits of the procedure. Candidates will be requested to complete a screening consent at this stage. Appropriate subjects will then undergo further medical screening procedures that include a number of examinations and investigations to determine their candidacy for hand transplantation. Prospective recipients who are selected based on results of screening procedures will be invited to review and sign the full informed consent form prior to being wait-listed for the procedure.
The screening tests include:
History and physical exam, including height and weight Urine pregnancy test for all female subjects of childbearing potential Complete blood count, differential, reticulocyte count, platelet count ABO type Liver function tests including SGPT or SGOT, serum bilirubin (total and direct), total protein, albumin, alkaline phosphatase and GGT, PT, PTT with INR Serum electrolytes and renal function panel to include the following: sodium, potassium, chloride, carbon dioxide, calcium, phosphorus, magnesium, glucose, creatinine and BUN Urinalys
Sponsor: University of Pittsburgh
Current Primary Outcome: Graft survival [ Time Frame: One to ten years ]
Original Primary Outcome: Same as current
Current Secondary Outcome: Functional Outcome [ Time Frame: One to ten years ]
Original Secondary Outcome: Same as current
Information By: University of Pittsburgh
Dates:
Date Received: July 23, 2008
Date Started: December 2008
Date Completion: January 2018
Last Updated: February 9, 2016
Last Verified: February 2016
