Ignite Creation Date:
2024-05-05 @ 11:31 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00063648
Status:
COMPLETED
Last Update Posted:
2010-01-13
First Post:
2003-07-01
Brief Title:
Detection and Cytotoxic T Lymphocyte Therapy of Post-Transplant Lymphoproliferative Disorder After Liver Transplant
Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases NIDDK
Organization:
National Institute of Diabetes and Digestive and Kidney Diseases NIDDK
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2010-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Despite advances in medical and gene therapy orthotopic liver transplantation remains the only definitive therapeutic option for children with end-stage liver disease Recent advances in pre- intra- and early post-transplant care have resulted in a dramatic improvement in survival of the pediatric liver transplant patient The broad long-range goal of our research program is directed at enhancing the patients long-term survival Our primary focus relates to obligate life-long immunosuppression with its inherent complications including severe infection and development of cancer These two complications come together in a single disease Epstein-Barr Virus EBV- associated post-transplant lymphoproliferative disorder PTLD EBV a latent human lymphotrophic herpes virus infects and immortalizes B cells Primary infection usually occurs via salivary exchange and results in a mild self-limited illness followed by life-long EBV-specific T cell controlled EBV latency T cell-based immunosuppression prevents allograft rejection however it also suppresses cytotoxic T lymphocyte CTL function generating an environment in which EBV-infected cells can proliferate Patients receiving life-long T cell-based immunosuppression have an increased risk of developing PTLD due to their inability to produce normal immunoregulatory responses This disease is particularly devastating to the pediatric patient as its incidence is at least 4-fold greater than in the adult liver transplant patient population In fact PTLD is the number one cause of death following pediatric liver transplantation At this time there is no definitive method of prospectively detecting diagnosing or treating PTLD and current treatment protocols place the liver allograft and patient at risk Therefore a diagnostic tool that is both sensitive and specific and a treatment strategy with low toxicity are greatly needed to decrease the morbidity and mortality suffered by the pediatric liver transplant patient with PTLD Our proposed studies will support our hypothesis that the combination of a persistently elevated EBV load in the setting of a diminished immune response to EBV will be an early risk indicator associated with PTLD development and that pre-emptive treatment utilizing autologous adoptive EBV-specific CTL immunotherapy will provide a low toxicity treatment option
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None