Strategies to Improve Islet Survival

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 and medications to support islet survival, for treating type 1 diabetes in individuals experiencing hypoglycemia unawareness and severe hypoglycemic episodes.

Conditions

• Type 1 Diabetes Mellitus

Interventions

PROCEDURE

Islet transplant

Transplantation of pancreatic islet cells

DRUG

Antithymocyte globulin

Immunosuppressive that selectively depletes activated T-cells and depletes resting T-cells in a dose-dependent manner.

DRUG

Basiliximab

Will replace antithymocyte globulin in all islet transplantations after the first one

DRUG

Lisofylline

An anti-inflammatory that may reduce the rate at which islet cells die.

DRUG

Sirolimus

Maintenance immunosuppressive therapy

DRUG

Tacrolimus

Maintenance immunosuppressive therapy

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

• Camillo Ricordi, MD · Department of Surgery, University of Miami Miller School of Medicine - Diabetes Research Institute

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

2006-12-31

Primary Completion

2011-11-30

Completion

2014-02-28

Countries

• United States

Study Locations