Modification of the "Edmonton Protocol" to Allow for Successful Islet Transplantation From a Single Pancreas and Extension of the "Edmonton Protocol" to Kidney Transplant Recipients

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. Read our disclaimer for details. Identifier: NCT00021580
Recruitment Status : Unknown
Verified April 2004 by National Center for Research Resources (NCRR).
Recruitment status was:  Active, not recruiting
First Posted : July 26, 2001
Last Update Posted : June 24, 2005
Juvenile Diabetes Research Foundation
Information provided by:
National Center for Research Resources (NCRR)

Brief Summary:

The experience of the Edmonton Group with islet transplantation and use of the "Edmonton Protocol" provides much promise for T1DM patients. However, the need to use 2 or more donor pancreases to achieve freedom from insulin shots limits the widespread use of this protocol. Two classes of oral antidiabetic drugs improve insulin action and reduce the amount of insulin needed to have normal blood sugars. The first part of the proposed project (Group 1) will use these drugs in conjunction with the Edmonton Protocol to allow for successful islet transplantation from islets isolated from a single pancreas.

The Edmonton Protocol is a treatment, not a cure. It requires the long-term use of powerful immunosuppressive drugs that are expensive and increase the risk of infection and cancer. T1DM patients who have a functioning kidney transplant already have to use immunosuppressive drugs, and they are still at risk of recurrent diabetic kidney disease and other complications of diabetes. Islet transplantation in these patients has only rarely been successful in the past in part because the usual immunosuppressive drugs used in kidney transplantation cause diabetes and actually harm the transplant kidney in other ways. The immunosuppressive drugs used in the Edmonton Protocol are less likely to cause diabetes and are also less harmful to the kidney. In the second part of this project (Group 2), we will transplant islets into kidney transplant patients after they have switched to the immunosuppressive medications used in the Edmonton Protocol. Even if some of the patients do not get islet transplants or still need insulin shots after islet transplantation, we expect to see improvement in kidney function and blood glucose control.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Procedure: human cadaveric islet cell transplantation Phase 1

Detailed Description:
We anticipate that successful islet transplantation will establish a group of islet cell transplant patients who have normal blood sugars and do not need insulin injections. Some of this group will have received a kidney transplant as well. All these patients will be studied in great detail along with other investigators in our islet cell program to understand better the mechanisms of efficacy and side effects of islet transplant and these new immunosuppressive drugs.

Study Type : Interventional  (Clinical Trial)
Allocation: Non-Randomized
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Modification of the "Edmonton Protocol" to Allow for Successful Islet Transplantation From a Single Pancreas and Extension of the "Edmonton Protocol" to Kidney Transplant Recipients (Project 1 of JDFI Washington University Center for Islet Transplantation)

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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

Type 1 diabetes for > 5 years AND Hypoglycemia unawareness, not felt adequately by patient (glucose < 54mg/dL) in last 1.6 years, not otherwise explained, requiring outside help OR Metabolic lability/instability, characterized by hypoglycemia or ketoacidosis (>2 hospital < 12 mo), chaotic glucose profile (MAGE > 120mg/dL), disruption in lifestyle or danger to life, to self, to others OR Failure of intensive insulin management, as judged by an independent endocrinologist.

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00021580

United States, Missouri
Washington University School of Medicine
St. Louis, Missouri, United States, 63110
Sponsors and Collaborators
National Center for Research Resources (NCRR)
Juvenile Diabetes Research Foundation Identifier: NCT00021580     History of Changes
Other Study ID Numbers: NCRR-M01RR00036-0775
First Posted: July 26, 2001    Key Record Dates
Last Update Posted: June 24, 2005
Last Verified: April 2004

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Gastrointestinal Agents