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Islet Transplantation in Patients With "Brittle" Type I Diabetes

NCT01630850 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2025-12-09

No results posted yet for this study

Summary

The purpose of this study is to learn about the safety of islet transplantation for Type 1 diabetes mellitus, which may provide more normal control of blood sugar without the need for insulin shots. Islets are special clusters of cells within the pancreas that produce insulin. These cells will be obtained from cadaver (non-living) donors and given to subjects by vein.

Conditions

  • Diabetes Mellitus, Type 1

Interventions

BIOLOGICAL

Allogenic islet cells (human, U. Chicago)

Human allogenic islet cells. Immunosuppression may include remicade, thymoglobulin,prograf, solu-medrol, and cellcept. 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, PhD · University of Chicago

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2012-05-31
Primary Completion
2030-06-30
Completion
2030-06-30

Countries

  • United States

Study Locations

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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 NCT01630850 on ClinicalTrials.gov