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B-Lymphocyte Immunotherapy in Islet Transplantation

NCT00468442 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 2

Last updated 2016-03-21

No results posted yet for this study

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 the 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

BIOLOGICAL

Allogeneic Pancreatic Islet Cells

transplant of islet cells injected into the portal vein of the liver

BIOLOGICAL

Antithymocyte globulin

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

BIOLOGICAL

Daclizumab

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

BIOLOGICAL

Rituximab

Depletes transient B-cells

DRUG

Sirolimus

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

  • Ali Naji, MD, PhD · University of Pennsylvania

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
2006-11-30
Primary Completion
2011-09-30
Completion
2011-09-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00468442 on ClinicalTrials.gov