Multi-Drug Desensitization Protocol for Heart Transplant Candidates
Status:
Terminated
Trial end date:
2016-05-01
Target enrollment:
Participant gender:
Summary
Background: Patients may develop antibodies (human leukocyte antigen [HLA] alloantibodies) to
other human tissues via pregnancy, transfusions or previous transplantation, which limits the
ability to find an acceptable donor heart for transplantation. Such patients are at high risk
for antibody mediated rejection, graft failure, and acute rejection (i.e. death). For
successful transplantation, patients must receive organs from donors who lack the HLA
antigens that correspond to their alloantibody specificities. No successful desensitization
strategy currently exists.
Purpose: To determine if desensitization by deletion of immunologic memory with a multi-drug
approach including anti-T and B cell therapies and anti-plasma cell therapy can effectively
eliminate or significantly reduce alloantibody levels and permit highly sensitized patients
to obtain a heart transplant. This therapy is anticipated to remove immunologic memory and
will require re-immunization.