Peritransplant Deoxyspergualin in 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 assess the safety and efficacy of deoxyspergualin (DSG), an immunosuppressant drug, on post-transplant islet function in people with type 1 diabetes who have not responded to intensive insulin therapy.

Conditions

• Diabetes Mellitus, Type 1

Interventions

BIOLOGICAL

Allogeneic Pancreatic Islet Cells

Preparation of allogeneic pancreatic islet cells injected into the portal vein of the liver

DRUG

Deoxyspergualin

An anti-inflammatory agent that blocks proinflammatory cytokine production and inhibits T-cells and B-cells and affects antigen presenting cells.

BIOLOGICAL

Antithymocyte globulin

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

BIOLOGICAL

Daclizumab or basiliximab

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

DRUG

Sirolimus

Maintenance immunosuppressive therapy

DRUG

Tacrolimus

Maintenance immunosuppressive therapy

BIOLOGICAL

Etanercept

Blocks TNF-alpha which is toxic to islet cells

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

• Xunrong Luo, MD, PhD · Northwestern University

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

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

2011-09-30

Completion

2013-11-30

Countries

• United States

Study Locations