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Islet Transplantation Alone (ITA) in Patients With Difficult to Control Type I Diabetes Mellitus Using a Glucocorticoid-free Immunosuppressive Regimen

NCT00706420 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2025-12-05

No results posted yet for this study

Summary

The purpose of this study is to evaluate the safety and effectiveness of islet cell transplantation alone (ITA) in patients with difficult to control type I diabetes. Difficult to control type 1 diabetes is defined as wide swings in blood glucose that disrupt the patient's life and result in frequent episodes of low blood glucose despite the proper use of standard insulin therapy and frequent blood glucose monitoring.

Conditions

Interventions

PROCEDURE

Islet Transplantation + Immunosuppression

Islet Transplantation + Immunosuppression (Sirolimus/Tacrolimus, daclizumab)

BIOLOGICAL

Islet cell transplantation

Islet cell transplantation will occur through the portal vein.

Sponsors & Collaborators

  • National Institutes of Health (NIH)

    collaborator NIH

  • City of Hope Medical Center

    lead OTHER

Principal Investigators

  • Fouad Kandeel, MD · City of Hope Medical Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-04-07
Primary Completion
2026-10-12
Completion
2026-10-12

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT00706420 on ClinicalTrials.gov