Type 1 Diabetes Clinical Trial
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
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.
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 120,000
in individuals aged 19 or less and 300,000 to 500,000 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
recipient's 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.
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