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Immunomodulatory / Minimization Protocol

Johns Hopkins Medicine IRB #NA_00046418
Principal Investigator: W.P. Andrew Lee, M.D.


What is “VCA?”

“VCA” stands for “Vascularized Composite Allograft,” and has also been referred to as CTA, or  “Composite Tissue Allograft.” 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.

Why is this research study being done?

Surgeons and researchers working on VCA research at Johns Hopkins are using an immunomodulatory / minimization protocol for immunosuppression after transplant. It is composed of two elements: Treating the patient with antibodies on the day of transplant, followed by a donor bone marrow infusion several days later. When used in solid organ and composite tissue transplants, this protocol allows patients to be treated with low doses of a single maintenance drug after being transplanted.

In the last decade, around 150 different VCA surgeries have been performed with great success including more than 85 hand and upper extremity transplants and 24 face transplants. Nevertheless, since its inception, VCA has encountered much speculation, debate, controversy, and scrutiny. Early world outcomes have confirmed that satisfactory-to-excellent function can be achieved with these types of procedures.

The main goal now is to minimize the risks of high-dose multiple drug therapy that is required to prevent rejection. Strategies like this Immunomodulatory Protocol that aim to reduce maintenance immunosuppression have been studied extensively in our laboratory and in solid organ transplantation. Our study physicians have successfully implemented this protocol in 5 patients receiving arm and/or hand transplants. We look forward to continuing to use this protocol in hand transplant patients and to implementing the protocol in face transplant patients. Realization of this treatment option in clinical VCA will allow us to treat complex and major tissue defects not amendable to conventional reconstruction with minimal anti-rejection medication.

What immunosuppressive treatment is currently used in vascularized composite allotransplantation (i.e., hand/arm, face) around the world?

Induction therapy with antibodies together with multi-drug maintenance therapy represents the standard treatment in human reconstructive transplants. Such drug regimens, while effective, have caused complications like infection and drug toxicity, among others, jeopardizing the benefits gained from otherwise successful transplants.

Who is on the Johns Hopkins Reconstructive Transplant Research Study Teams?

Principal Investigator
W.P. Andrew Lee, M.D., Chairman of the Department of Plastic Surgery and Reconstructive Surgery

Hand / Arm Transplant Co-Investigators
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

Face Transplant Co-Investigators
Chad Gordon, D.O., Clinical Director of Face Transplantation
Patrick Byrne, M.D., Co-PI and Study Surgeon
Gerald Brandacher, M.D., Scientific Director of the VCA Program
Stefan Schneeberger, M.D., Study Surgeon
Jaimie Shores, M.D., Clinical Director of Hand Transplantation
Steven Bonawitz, M.D., Study Surgeon
Damon S. Cooney, M.D., Ph.D., Study Surgeon
Justin Sacks, M.D., Study Surgeon

Who is eligible to participate in this research study?

This study is open to patients requiring either a hand / arm transplant or a face transplant.

Hand and arm transplant: People between the ages of 18 and 69 years with amputation below the shoulder are eligible.

Face transplant: People between the ages of 18 and 60 years with a severe facial injury or deformity are eligible.

Those who fit these criteria will be rigorously evaluated before being considered candidates for hand/arm or face transplantation. Learn more about participating in the Hand and Arm Transplant Study or the Face Transplant study. Or, contact the study’s Reconstructive Transplant Coordinator at (410) 955-6875. If you get an automated message, please leave a voicemail with a telephone number and a good time to contact you.

Where can I get more information about this research study?

For more information about the Immunomodulatory / Minimization Protocol Used by the Johns Hopkins VCA Transplant Team , contact the study’s Transplant Coordinator at (410) 955-6875. If you get an automated message, please leave a voice mail with a telephone number and a good time to contact you.

 

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