Islet Transplantation in Patients With "Brittle" Type I Diabetes

Part of paid clinical trials in Chicago, Illinois.

Sponsor
University of Chicago
Study ID
NCT01630850
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Allogenic islet cells (human, U. Chicago) — BIOLOGICAL
    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.
  • Intraportal infusion of islet cells — PROCEDURE
    Intraportal infusion of islet cell through the portal vein in the liver.

Study Details

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.

Key Dates

Start date
May 31, 2012
Status verified
Dec 2025
Primary completion
Jun 30, 2030
Completion
Jun 30, 2030

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Allogenic islet cells (human, U. Chicago)

Primary Outcome Measure

HbAlc <7.0% and an absence of severe hypoglycemic events [ Time Frame: 1 year ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Chicago Medical CenterChicagoIllinois60637
Lindsay Basto, RN, BSN
[email protected]
773-702-2504
Piotr Witkowski, MD, PhD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Chicago, IL

By condition
Type 1 diabetes
By specialty
Endocrinology
By research site
University of Chicago Medical Center· Chicago, IL

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