Clinical Trial: Islet Transplant for Type 1 or Surgical Diabetes
Study Status: No longer available
Recruit Status: No longer available
Study Type: Expanded Access
Official Title: Human Alloislet Transplant for Type 1 or Surgical Diabetes Mellitus With Complications
Brief Summary:
The purpose of this study is to evaluate the safety and efficacy of islet transplants from human cadaver donors into type 1 or surgical diabetes mellitus patients who experience frequent acute or advanced chronic complications but do not qualify for other islet transplant trials. Under this protocol, patients may receive intraportal alloislet transplant under one of the following scenarios:
- islet transplant alone
- simultaneous islet-kidney transplant, or 3)islet after kidney transplant.
Detailed Summary: The overall objective of this study is to evaluate the efficacy of islet allotransplants for labile diabetes mellitus in patients who do not meet standard inclusion/exclusion criteria for any other islet transplant trials in the US and are not good candidates for a pancreas transplant. We expect that this will include patients who have surgical diabetes (total pancreatectomy) rather than type 1 diabetes, patients who are highly sensitized (PRA>20%), and patients who have had prior failed pancreas transplantation. These patients may have equally severe hypoglycemia, glucose lability, and/or severe microvascular complications, but are excluded from standard islet transplant trials currently available in the U.S.
Sponsor: University of Minnesota - Clinical and Translational Science Institute
Current Primary Outcome:
Original Primary Outcome:
Current Secondary Outcome:
Original Secondary Outcome:
Information By: University of Minnesota - Clinical and Translational Science Institute
Dates:
Date Received: May 23, 2012
Date Started:
Date Completion:
Last Updated: February 27, 2017
Last Verified: February 2017
