Allograft Rejection Clinical Trial
Official title:
Low Dose Ex-Vivo X-Irradiation of the Allograft and Simultaneous Bone Marrow Cell Infusion to Enhance Intestinal/Multivisceral Allograft Survival
The specific aims of this study is to improve short and long-term patient and graft survival, to reduce the incidence and severity of allograft rejection, to reduce the incidence of infection and to reduce and/or eventually eliminate the need for long-term immunosuppression.
The rationale behind this study involves the need to better manage rejection in the
intestinal allograft recipient. Although tacrolimus based immunosuppression has made
intestinal transplantation feasible, the requisite need for chronic high dose
immunosuppression in order to control rejection has inhibited the wide spread clinical use
and practicality of intestinal/multivisceral transplantation. The measures needed to prevent
graft loss have frequently resulted in lethal infections, the leading cause of death. This
trial is significant for determining if this new strategy of allograft immune-modulation
with low dose ex-vivo irradiation and simultaneous done bone marrow cell infusion will
favorably affect short and long term outcomes by reducing the risk of allograft rejection.
This trial is offered to all patients with irreversible intestinal failure who must undergo
intestinal, combined liver-intestinal, and multivisceral transplantation at the University
of Pittsburgh Medical Center. Patients are recruited through the referral system and no cold
calling is carried out. Patient confidentiality is maintained by the use of codes to
identify the study participants. All data is stored in a locked filing cabinets as a means
to protect participants against a breach of confidentiality. This trial involves ex-vivo low
dose irradiation of the intestinal allograft with or without adjunct donor bone marrow cell
infusion. An intravenous bone marrow cell infusion is prepared form the thoracolumbar
vertebral bodies harvested from cadaveric donors. Control subjects will be those who refuse
to be enrolled in the study or those for whom donor bone marrow is not available. All
patients will be treated perioperatively with thymoglobulin, a rabbit polyclonal
anti-lymphocyte globulin at a dose of 5-10 mg/kg. Tacrolimus will be given in a standard
fashion and from the outset as a single monotherapeutic agent to prevent early allograft
rejection and promote graft acceptance. All patients will be monitored for rejection, graft
function, opportunistic infections and GVHD. Surveillance endoscopy with guided mucosal
biopsies will be obtained according to the standard protocol. Attention will be paid for any
clinicopathologic changes suggestive of acute or chronic irradiation injuries.
The study closed for enrollment as of 9/30/03.
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Time Perspective: Prospective
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