Low Dose Irradiation for Small Bowel Transplant

This study has been completed.
Sponsor:
Information provided by:
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00382486
First received: September 28, 2006
Last updated: December 13, 2007
Last verified: December 2007
  Purpose

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.


Condition Intervention
Irreversible Intestinal Failure
Allograft Rejection
Procedure: Reduce the risk of allograft rejection

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Low Dose Ex-Vivo X-Irradiation of the Allograft and Simultaneous Bone Marrow Cell Infusion to Enhance Intestinal/Multivisceral Allograft Survival

Further study details as provided by University of Pittsburgh:

Estimated Enrollment: 100
Study Start Date: July 2001
Study Completion Date: September 2003
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   17 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • all patients between 17 and 70 who are diagnosed with intestinal failure awaiting intestinal/multivisceral transplant

Exclusion Criteria:

  • active systemic/abdominal infections
  • incurable malignancy
  • acquired immune deficiency syndrome
  • severe cardiopulmonary insufficiency
  • current alcoholism
  • pregnant female
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00382486

Locations
United States, Pennsylvania
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
University of Pittsburgh
Investigators
Principal Investigator: Kareem M Abu-Elmagd, MD University of Pittsburgh
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00382486     History of Changes
Other Study ID Numbers: 0311041
Study First Received: September 28, 2006
Last Updated: December 13, 2007
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pittsburgh:
Intestinal transplant
Bone marrow
Irradiation of allograft

ClinicalTrials.gov processed this record on October 21, 2014