Clinical Research Trials/Special Protocols
Renal allograft tolerance through mixed chimerism
Why is this study/special protocol being performed?
The objective of this study is to determine whether tolerance to a kidney transplant can be induced so that all immunosuppression can be safely withdrawn. Tolerance means that the recipient’s immune system regards the the kidney as "self" rather than as "foreign," so that the kidney is not rejected even after stopping the anti-rejection drugs. This study is currently available only for living donor kidney transplant recipients who will receive treatment prior to transplantation.
Who is eligible to participate in this study/special protocol?
Any person who has a potential living donor willing to provide both a kidney and bone marrow, and whose ABO blood type is compatible
Minimum age
18 (Note: While the current protocol only enrolls patients over 18, we are currently developing a protocol for children, and we welcome inquiries.)
Maximum age
55
What is involved with this study/protocol?
A conditioning regimen that includes cyclophosphamide, Medi-507 (anti-T cell antibody), Rituximab (anti-B cell antibody), local thymic irradiation and bone marrow infusion, in addition to the usual treatments for kidney transplantation
How long will the study run?
3 years
For more information or to participate in this research study/special protocol, please contact Sandy Debronkart at 617-726-2631 or e-mail sdebronkart@partners.org.
ABO blood group incompatible kidney transplantation
Why is this study/special protocol being performed?
Kidney transplantation is now quite common. However, in the past, kidney transplantation was seldom successful between persons with incompatible blood types (type A, B, or O).
We are performing this study to evaluate the safety and efficacy of a new procedure for kidney transplantation between persons with incompatible blood types.
Who is eligible to participate in this study/special protocol?
Any renal failure patient who has an ABO blood type incompatible donor
Minimum age
18
Maximum age
60
What is involved with this study/protocol?
Antibodies against incompatible blood types can now be removed with a procedure called plasmapheresis. During plasmapheresis, blood is separated into cells and plasma (liquid). This procedure, also referred to as plasma exchange, reduces the amount of antibodies located in the blood. Additionally, a newer medication (Rituximab) can prevent these antibodies from being re-made in dangerous quantities once they have been removed. The hospital stay will be about one week after kidney transplantation.
How long will the study run?
3 years
For more information or to participate in this research study/special protocol, please contact Sandra Debronkart at 617-726-2631 or e-mail sdebronkart@partners.org.
Kidney transplantation for a cross-match positive recipient
Why is this study/special protocol being performed?
In the past, kidney transplantation was seldom successful if cross-match tests between a donor and a recipient were positive. In this case, a recipient has already been sensitized by a donor and has rejected a kidney soon after transplantation. We now offer a special protocol for such patients to be able to receive kidney transplantation.
Who is eligible to participate in this study/special protocol?
Any renal failure patient who has a cross-match positive donor
Minimum age
18
Maximum age
65
What is involved with this study/protocol?
Antibodies against incompatible blood types can now be removed with a procedure called plasmapheresis. During plasmapheresis, blood is separated into cells and plasma (liquid). This procedure, also referred to as plasma exchange, reduces the amount of antibodies located in the blood. Additionally, a newer medication (Rituximab) can prevent these antibodies from being re-made in dangerous quantities once they have been removed. The hospital stay will be about one week after kidney transplantation.
How long will the study run?
3 years
For more information or to participate in this research study/special protocol, please contact Sandra Debronkart at 617-726-2631 or e-mail sdebronkart@partners.org.
Basic And Clinical Transplantation Research
At Massachusetts General Hospital, we have integrated our Transplantation Research programs across all organ and diverse basic and clinical research programs. We are actively studying the basic science of transplantation in both the Transplant Center and the Transplantation Biology Research Center (TBRC). Multiple exciting Clinical Trials/Special Clinical Protocols are in progress at the MGH Transplant Center.
The ultimate goal of transplantation research at MGH is to establish the methodology for tolerance induction in organ transplantation, so that transplant recipients will not need to take immunosuppressive medications lifelong to prevent graft rejection. Our basic studies for tolerance induction have been successfully translated to clinical kidney transplantation — some of these studies have been described recently in the New England Journal of Medicine. Studies are under way to extend these methods for recipients of other organs.
Studies at MGH are also aimed at overcoming other immunologic barriers in clinical transplantation. These barriers include ABO blood type incompatibility and donors and recipients with positive cross-matches that have prevented transplantation in the past. Special clinical protocols for these innovative types of transplants have been successfully performed at the MGH Transplant Center.
Massachusetts General Hospital has a long-standing effort to solve the shortage of organs for transplantation by developing clinical xenotransplantation — the transplantation of organs from special herds of genetically modified miniature swine. This is one of the major goals of research efforts at the MGH Transplant Center.
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