NCT01606475

Islet Transplant for Type 1 or Surgical Diabetes

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

• Status: No Longer Available
• Phase: —
• Study type: Expanded Access
• Enrollment: —
• Sponsor: University of Minnesota · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: —

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.

Detailed 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.

Conditions

• Type 1 Diabetes Mellitus
• Hypoglycemia
• Labile Diabetes
• End-stage Renal Disease

Interventions

Type	Name	Description
BIOLOGICAL	Allogeneic islets of Langerhans	Up to 3 intraportal infusions of cadaveric pancreatic islets of Langerhans. Each infusion to contain at least 5,000 islet equivalents/kg body weight.

Timeline

• First posted: 2012-05-25
• Last updated: 2025-08-14

Locations

1 site across 1 country: United States