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Islet Transplant for Type 1 or Surgical Diabetes (EXAX)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT01606475
Expanded Access Status : Available
First Posted : May 25, 2012
Last Update Posted : July 10, 2020
Information provided by (Responsible Party):
University of Minnesota

Tracking Information
First Submitted Date May 23, 2012
First Posted Date May 25, 2012
Last Update Posted Date July 10, 2020
Descriptive Information
Brief Title Islet Transplant for Type 1 or Surgical Diabetes
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:

  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.
Study Type Expanded Access
Intervention 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.
Other Name: Islets
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Expanded Access Status Available
Contact: Jayne Pederson 612-624-8402
Listed Location Countries United States
Removed Location Countries  
Administrative Information
NCT Number NCT01606475
Responsible Party University of Minnesota
Study Sponsor University of Minnesota
Collaborators Not Provided
Principal Investigator: Bernhard J Hering, M.D. University of Minnesota
PRS Account University of Minnesota
Verification Date July 2020