B-Lymphocyte Immunotherapy in Islet Transplantation

Part of paid clinical trials in Philadelphia, Pennsylvania.

Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Study ID
NCT00468442
Phase
PHASE2
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Allogeneic Pancreatic Islet Cells — BIOLOGICAL
    transplant of islet cells injected into the portal vein of the liver
  • Antithymocyte globulin — BIOLOGICAL
    Immunosuppressive that selectively depletes activated T-cells and depletes resting T-cells in a dose-dependent manner.
  • Daclizumab — BIOLOGICAL
    Will replace antithymocyte globulin in all islet transplantations after the first one
  • Rituximab — BIOLOGICAL
    Depletes transient B-cells
  • Sirolimus — DRUG
    Maintenance immunosuppressive therapy

Study Details

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.

Key Dates

Start date
Nov 30, 2006
Status verified
Feb 2016
Primary completion
Sep 30, 2011
Completion
Sep 30, 2011

Study Design

Enrollment
2 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Allogeneic Pancreatic Islet Cells
    Participants will receive up to three islet transplants and maintenance immunosuppressive therapy.

Primary Outcome Measure

Insulin independence [ Time Frame: 75 days after a single islet transplant ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of PennsylvaniaPhiladelphiaPennsylvania--

Find similar trials in Philadelphia, PA

By condition
Type 1 diabetes
By specialty
Endocrinology
By research site
University of Pennsylvania· Philadelphia, PA

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