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Cadaveric Islet Transplantation in Patients With Insulin-Dependent Diabetes Mellitus

NCT00579371 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2023-12-21

No results posted yet for this study

Summary

We hypothesize that the following improvements to islet transplantation will increase the islet mass successfully isolated and allow for engraftment from a single pancreas. The improvements are:

* Using Two-Layer method preservation to improve pancreas quality before islet isolation
* Maintaining isolated islets in culture before transplantation
* Using a steroid-free immunosuppression regimen
* Transplanting the best combination of donor and recipient possible after human leukocyte antigens (HLA) screening and final crossmatching

Conditions

  • Islets of Langerhans Transplantation
  • Diabetes Mellitus, Type 1

Interventions

DRUG

Islets of Langerhans

Subjects will receive islets isolated from one donor pancreas per transplantation event. Subjects will receive a cumulative dose of 8,000IE/kg. Islets will be infused intraportally. If necessary, additional transplantation events will be performed.

Sponsors & Collaborators

  • University of Nebraska

    lead OTHER

Principal Investigators

  • R Brian Stevens, MD PhD · University of Nebraska

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2004-03-17
Primary Completion
2011-03-31
Completion
2011-03-31
FDA Drug
Yes

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 NCT00579371 on ClinicalTrials.gov