Islet Transplant for Type 1 or Surgical Diabetes — EXAX  

Type 1 Diabetes Mellitus Clinical Trial

Official title: Human Alloislet Transplant for Type 1 or Surgical Diabetes Mellitus With Complications

Status Available

Clinical Trial 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:

1. islet transplant alone

2. simultaneous islet-kidney transplant, or 3)islet after kidney transplant.

Clinical Trial Description

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. ;

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• End-stage Renal Disease
• Hypoglycemia
• Kidney Failure, Chronic
• Labile Diabetes
• Type 1 Diabetes Mellitus

• NCT number: NCT01606475
• Study type: Expanded Access
• Source: University of Minnesota
• Contact: Melena Bellin, MD
• Phone: 612-625-4686
• Email: bell0130@umn.edu
• Status: Available