Ignite Creation Date:
2024-05-05 @ 12:01 PM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00214786
Status:
COMPLETED
Last Update Posted:
2017-06-14
First Post:
2005-09-14
Brief Title:
Pancreatic Islet Cell Transplantation
Sponsor:
Baylor Research Institute
Organization:
Baylor Research Institute
Study Overview
Official Title:
Pancreatic Islet Cell Transplantation - A Novel Approach to Immunosuppression and Validation of Remote Site Islet Cell Processing Islet Cell Culture and Two-Layer Preservation
Status:
COMPLETED
Status Verified Date:
2017-06
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:
The purpose of this study is to assess a novel approach to immunosuppression in allogenic pancreatic islet cell transplant recipients In addition the study aims to assess remote site islet processing with culture for pancreatic islet cell transplantation in human subjects
Detailed Description:
The purpose of this study is to assess a novel approach to immunosuppression in allogenic pancreatic islet cell transplant recipients In addition the study aims to assess remote site islet processing with culture for pancreatic islet cell transplantation in human subjects
Detailed Description Diabetes mellitus DM type I is a disease that has significant social and economical impact The prevalence of the disease in the United States is about 120000 in individuals aged 19 or less and 300000 to 500000 at all ages and 150 million worldwide
So far there are no mechanical devices able to effectively adjust the dose of insulin injected according to the serum glucose in patients with DM This leads to less than perfect sugar control with episodes of hypoglycemia Successful pancreas transplantation averts the need of insulin administration
The emerging alternative to whole organ pancreas transplantation is pancreatic islet cell transplantation ICT The process is based on the enzymatic isolation of the pancreatic islets from an organ procured from a cadaver donor The islets obtained are injected into the liver in the recipient via percutaneous catheterization of the portal venous system This procedure allows the selective transplantation of the insulin-producing cell population avoiding open surgery as well as the transplantation of the duodenum and the exocrine pancreas and their related morbidity
The initial efforts with ICT had only modest results The immunosuppression regimen was similar to the one used in solid organ transplantation based on high dose steroids and calcineurin inhibitors - both agents with diabetogenic effects The results improved markedly with the changes in the manipulations of the islets and the change in immunosuppression thus avoiding the higher doses of steroids and using sirolimus tacrolimus and daclizumab initiated by the investigators group at the University of Alberta in Edmonton Canada Their protocol requires in general two islet cell infusions in order to attain the critical cell mass necessary to achieve insulin-independency The changes in treatment were adopted as the Edmonton Protocol which is used in several transplant centers worldwide
A novel approach to organ preservation uses the two-layer preservation technique This allows for longer travel time for the eventual shipment of the pancreas to an islet cell processing facility remotely located from the donor procurement site
The isolation of the islets from the donor pancreas will be performed at the Diabetes Research Institute in Miami Florida according to the standard currently used by that institution The Diabetes Research Institute is a well-established center with a state-of-the-art islet cell isolation facility for the purpose of transplantation in humans accredited and monitored by the FDA according to FDA standards
The focus of the research in the ICT is centered on the development of a safe and effective procedure that will eventually replace surgical pancreas transplantation together with an ideal immunosuppressive regimen that provides safe and effective prevention against rejection while minimizing the adverse events associated that negatively impact transplant recipients quality of life
This study is being conducted as a validation of the Edmonton protocol for ICT at our institution Our aim is to test the efficacy of the use of the two-layer preservation technique for transport of the donor pancreas to the off-site processing facility and the use of islet cell culture in the off-site processing facility before the islet isolate is shipped to our center
Detailed Description Diabetes mellitus DM type I is a disease that has significant social and economical impact The prevalence of the disease in the United States is about 120000 in individuals aged 19 or less and 300000 to 500000 at all ages and 150 million worldwide
So far there are no mechanical devices able to effectively adjust the dose of insulin injected according to the serum glucose in patients with DM This leads to less than perfect sugar control with episodes of hypoglycemia Successful pancreas transplantation averts the need of insulin administration
The emerging alternative to whole organ pancreas transplantation is pancreatic islet cell transplantation ICT The process is based on the enzymatic isolation of the pancreatic islets from an organ procured from a cadaver donor The islets obtained are injected into the liver in the recipient via percutaneous catheterization of the portal venous system This procedure allows the selective transplantation of the insulin-producing cell population avoiding open surgery as well as the transplantation of the duodenum and the exocrine pancreas and their related morbidity
The initial efforts with ICT had only modest results The immunosuppression regimen was similar to the one used in solid organ transplantation based on high dose steroids and calcineurin inhibitors - both agents with diabetogenic effects The results improved markedly with the changes in the manipulations of the islets and the change in immunosuppression thus avoiding the higher doses of steroids and using sirolimus tacrolimus and daclizumab initiated by the investigators group at the University of Alberta in Edmonton Canada Their protocol requires in general two islet cell infusions in order to attain the critical cell mass necessary to achieve insulin-independency The changes in treatment were adopted as the Edmonton Protocol which is used in several transplant centers worldwide
A novel approach to organ preservation uses the two-layer preservation technique This allows for longer travel time for the eventual shipment of the pancreas to an islet cell processing facility remotely located from the donor procurement site
The isolation of the islets from the donor pancreas will be performed at the Diabetes Research Institute in Miami Florida according to the standard currently used by that institution The Diabetes Research Institute is a well-established center with a state-of-the-art islet cell isolation facility for the purpose of transplantation in humans accredited and monitored by the FDA according to FDA standards
The focus of the research in the ICT is centered on the development of a safe and effective procedure that will eventually replace surgical pancreas transplantation together with an ideal immunosuppressive regimen that provides safe and effective prevention against rejection while minimizing the adverse events associated that negatively impact transplant recipients quality of life
This study is being conducted as a validation of the Edmonton protocol for ICT at our institution Our aim is to test the efficacy of the use of the two-layer preservation technique for transport of the donor pancreas to the off-site processing facility and the use of islet cell culture in the off-site processing facility before the islet isolate is shipped to our center
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