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Allogenic Islet Cell Transplantation

NCT00160732 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2025-12-08

No results posted yet for this study

Summary

The purpose of this study is to determine the safety of transplanting human islet cells for controlling hyperglycemia in brittle and/or complex patients with type 1 diabetes. In addition, initial observations will be made with regards to the effectiveness of reversing hypoglycemia with this treatment. The "Edmonton Protocol" of using specific anti-rejection drugs without steroids is also being evaluated.

Conditions

  • Diabetes Mellitus, Type 1

Interventions

DRUG

Allogenic islet cells (human, U. Chicago)

Human allogenic islet cells. Immunosuppression varies but may include prograf, celcept, sirolimus, prednisone. Dosage will vary per patient based on weight. Patients will receive immunosuppression medications while islet cells are functioning.

PROCEDURE

Intraportal infusion of islet cells

Intraportal infusion of islet cell through the portal vein in the liver.

Sponsors & Collaborators

  • University of Chicago

    lead OTHER

Principal Investigators

  • Piotr Witkowski, MD, Ph.D. · University of Chicago

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2003-10-31
Primary Completion
2030-10-31
Completion
2030-10-31

Countries

  • United States

Study Locations

More Related Trials

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 NCT00160732 on ClinicalTrials.gov