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NCT00579371 · ClinicalTrials.gov registry record · Phase 1

Cadaveric Islet Transplantation in Patients With Insulin-Dependent Diabetes Mellitus

A Phase 1 study, sponsored by University of Nebraska.

Terminated
Registry status
Phase 1
Development phase
30
Enrollment target

NCT00579371: Clinical Trial Phase 1 study, sponsored by University of Nebraska.

NCT00579371 is a Phase 1 study that was terminated before completion, run by University of Nebraska. The registered enrollment target is 30 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (50% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00579371, a Phase 1 study, was terminated before completion, sponsored by University of Nebraska.

TERMINATED
Registry status
Phase 1
Development phase
30 participants
Enrollment target

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

Primary Outcome

Incidence of insulin independence with a single transplantation measured at one year post-transplantation.

Interventions

  • DRUG Islets of Langerhans

Trial Details

FieldValue
Enrollment Target 30 participants
Start Date 2004-03-17
Est. Completion 2011-03
Phase Phase 1
University of Nebraska

407 total trials

Why NCT00579371 stopped before completion

NCT00579371 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (50% lower).

The record links to 0 conditions, and to 1 intervention - of which Islets of Langerhans is the first listed.

NCT00579371 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00579371 about?

NCT00579371 is a clinical study titled "Cadaveric Islet Transplantation in Patients With Insulin-Dependent Diabetes Mellitus". 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 i...

What is the current status of trial NCT00579371?

This trial is currently terminated. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2004-03-17. Estimated completion is 2011-03.

What interventions are being tested in trial NCT00579371?

The interventions under investigation include: Islets of Langerhans (DRUG).

Who is sponsoring clinical trial NCT00579371?

This trial is sponsored by University of Nebraska, which has 407 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00579371's enrollment target sits among peer trials

30 1332nd of 2000 higher than 561 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00579371, the US trial registry maintained by the National Library of Medicine. NCT00579371 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.