A Hand and Arm Transplant Research Study
Johns Hopkins Medicine IRB #NA_00046418
Principal Investigator: W.P. Andrew Lee, M.D.
- What is “VCA?”
- Why is this research study being done?
- What immunosuppressive treatment is currently used in hand/arm transplants around the world?
- Who is on the Johns Hopkins Hand and Arm Transplant Research Study Team?
- Why would I need a reconstructive hand transplant?
- Am I eligible for a hand/arm transplant?
- How many total hand/arm transplants have been performed worldwide?
- What is a hand/arm transplant surgery like?
- How do you find hand transplant donors? Is that included in the organ donation box on my driver’s license?
- How long will I have to wait for a transplant?
- What is physical therapy like after hand/arm transplant surgery?
- What is rejection after hand/arm transplant?
- What does rejection look like in hand/arm transplants?
- How many hands/arms have been lost to rejection?
- Where can I get more information about this research study?
“VCA” stands for “Vascularized Composite Allotransplantation,” and has also been referred to as CTA, or "Composite Tissue Allotransplantation." VCA is the umbrella term used to refer to transplants composed of several kinds of tissues (i.e., skin, muscle, bone), like the hand, arm or face.
Surgeons and researchers working on the research study at Johns Hopkins are proposing the use of an immunomodulatory / minimization protocol for immunosuppression after hand/arm transplant. This protocol is different from most other immunosuppression protocols used to prevent rejection of hand/arm transplants in the United States. For more information about this protocol, visit the Immunomodulatory / Minimization Protocol Website.
The standard treatment in human hand/arm transplants involve induction therapy with antibodies combined with multi-drug maintenance therapy. While effective, such drug regimens have caused complications like infection and drug toxicity, among others, jeopardizing the benefits gained from otherwise successful hand/arm transplants.
W.P. Andrew Lee, M.D., Chairman of the Department of Plastic Surgery and Reconstructive Surgery
Jaimie Shores, M.D., Clinical Director of Hand Transplantation
Gerald Brandacher, M.D., Scientific Director of the VCA Program
Stefan Schneeberger, M.D., Study Surgeon
Damon S. Cooney, M.D., Ph.D., Study Surgeon
Justin Sacks, M.D., Study Surgeon
Reconstructive hand transplants are for adults who have suffered a hand/arm amputation or extreme loss of function due to injury or illness. You may consider such a transplant if you have almost no function of your hands and are not a candidate for alternative or conventional reconstructive surgery. You may be a candidate for reconstructive transplant if you have lost either one hand or both at any level from the hand to the upper arm. Individuals who have only lost fingers or have lost the entire arm from the shoulder are not currently eligible for this type of transplant.
To be eligible for a hand transplant, you must meet the following criteria. This is a general list and in order to determine full eligibility, you should meet with the reconstructive transplant team.
- 18 – 69 years of age
- Below the shoulder amputation or severe deformity of hand or arm
- No history of HIV or hepatitis C
- Able to take immunosuppressive drugs
- No history of cancer for at least five years
- Willingness to forgo pregnancy for one year
For more information on participating in the study, contact the study's Reconstructive Transplant Coordinator at (410) 502-3895. If you get an automated message, please leave a voicemail with a telephone number and a good time to contact you.
More than 85 patients have received hand/arm transplants at institutions around the world. The longest surviving hand/arm transplant is the first U.S. recipient at 11 years.
The human hand consists of 27 bones, 28 muscles, 3 major nerves, 2 major arteries, multiple tendons, veins and soft tissue. Hand transplant surgery is complex and can last from 8-10 hours. It involves bone fixation, reattachment of arteries and veins and repair of tendons and nerves.
Patients waiting for a hand donation can be called into the hospital for surgery at any time. After surgery, you will be placed in a surgical intensive care unit (SICU) for several days. Once the surgical team feels comfortable with you being moved out of the SICU, you will move to a transplant unit, where you will receive care specially designed for all types of transplant patients. You can expect to be in the hospital anywhere from four weeks to three months. The amount of time spent in the hospital depends on a number of factors, including the amount of support and assistance you have at home, the distance from your home to the hospital for follow-up care, and any delays that might occur in recovery.
How do you find hand transplant donors? Is that included in the organ donation box on my driver’s license?
Hand donation is not included in the commonly used driver’s license organ donation registry. Hand donation involves a special and sensitive consent process with donor families. For Johns Hopkins patients, this process is facilitated through specially trained and experienced coordinators from the Living Legacy Foundation of Maryland, which is the organ procurement organization for the state of Maryland (with the exception of Charles, Montgomery and Prince Georges counties, which are covered by the Washington Regional Transplant Community).
In addition to matching blood type and immunological parameters like in solid organ transplantation, hand donation involves careful emphasis on matching skin color, skin tone, gender, ethnicity/race, and the size of the hand/arm.
Once you are approved for a hand transplant, you will have to wait for a matching donor to become available. This can range from a few weeks to several months. The donor must have matching blood and tissue types as well as matching skin color, skin tone, gender, ethnicity, race and size of hand.
Hand transplant patients should be prepared for an intensive rehabilitation process. You will be involved in some form of rehabilitation for the rest of your life and patients are educated before surgery on the critical importance of rehabilitation in improving functional outcome after the procedure. Patients are encouraged to start moving the hand early (usually within 24 to 48 hours) to reduce edema and stiffness. All patients will be required to attend directed hand therapy for 6+ hours each day, 5 days a week, for the first 3-6 months after the transplant. Therapy will be tailored to your needs and abilities; however, you should understand that caring for and rehabilitating transplanted hands becomes a full-time job for the first 1-2 years after the transplant.
Rejection refers to the body’s immune response towards the newly transplanted limb. Believing the tissues to be “foreign,” the body’s natural response is to attack and can occur within days to months after transplant. A special scoring system to monitor VCA rejection was established in 2008 (Cendales et al).
Rejection can appear as a rash that could be spotty, patchy or blotchy. It could appear anywhere on the transplant and is usually painless. As rejection almost always appears first in the skin, patients are encouraged to carefully watch for the signs and report to the physician for timely biopsy and treatment. Unlike internal organ transplants, it is easy to detect and monitor signs of rejection in the hand/arm. This allows for early medical intervention.
No patient taking his/her immunosuppression drugs on time and as advised has lost a transplanted hand/arm.
For more information about the Johns Hopkins hand and arm transplant research study, contact the study’s Reconstructive Transplant Coordinator at (410) 502-3895. If you get an automated message, please leave a voice mail with a telephone number and a good time to contact you.