Islet Transplantation in Type 1 Diabetes

Summary

Type 1 diabetes is an autoimmune disease in which the insulin-producing pancreatic beta cells are destroyed, resulting in poor blood sugar control. The purpose of this study is to determine the safety and effectiveness of islet transplantation, combined with immunosuppressive medications, for treating type 1 diabetes in individuals experiencing hypoglycemia unawareness and severe hypoglycemic episodes.

Conditions

• Type 1 Diabetes Mellitus

Interventions

BIOLOGICAL

Allogeneic Pancreatic Islet Cells

200 ml suspension of allogenic human purified islets

BIOLOGICAL

Antithymocyte Globulin

Participants will begin receiving ATG 2 days prior to the first islet transplant. ATG will continue to be given until Day 2 post-transplant.

DRUG

Sirolimus

Participants will begin receiving sirolimus 2 days prior to the first islet transplant and will be given for the duration of the study.

DRUG

Tacrolimus

On Day 1 post-transplant, participants will receive tacrolimus, which will also be taken for the duration of the study.

BIOLOGICAL

Etanercept

Etanercept will be taken on the day of transplant and Days 3, 7, and 10 post-transplant.

PROCEDURE

Islet Transplantation

Transplantation of pancreatic islet cell

BIOLOGICAL

Basiliximab

Basiliximab will be used in place of ATG for the second and third transplants, if they are necessary.

Sponsors & Collaborators

• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

  collaborator NIH

• National Institute of Allergy and Infectious Diseases (NIAID)

  lead NIH

Principal Investigators

• Bernhard Hering, MD · University of Minnesota

• Olle Korsgren, PhD · Uppsala University Hospital

• Ali Naji, PhD · University of Pennsylvania

• Camillo Ricordi, MD · University of Miami

• James Shapiro, MD, PhD · University of Alberta

• Andrew Posselt, MD, PhD · University of California, San Francisco

• Nicole Turgeon, MD · Emory University

• Xunrong Luo, MD, PhD · Northwestern Univerity

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2006-10-31

Primary Completion

2012-09-30

Completion

2014-05-31

FDA Drug

Yes

Countries

• United States
• Canada

Study Locations