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COMPLETED Phase 2

Islet Transplantation for Type 1 Diabetes

NCT00014911 · View on ClinicalTrials.gov ↗

Study Summary

The purpose of this study is to test whether the islet cell transplantation procedures and results from a previous study in Edmonton, Canada, can be repeated. The study also is designed to learn more about diabetes control using islet cell transplantation. This is a Phase I/II study (a study that examines effectiveness and looks for side effects). The transplanting of islet cells has been studied in Type 1 diabetic patients whose blood sugar levels will not stay normal, despite intensive insulin therapy. A recent study conducted in Edmonton, Canada, was able to demonstrate that islet transplantation led to insulin independence in a majority of the patients treated. This study extends the results obtained from the Edmonton study, which used islet transplantation in Type 1 diabetic patients with steroid-free immunosuppression.

Interventions

  • DRUG Sirolimus
  • DRUG Tacrolimus
  • DRUG Daclizumab
  • PROCEDURE Islet Transplantation
  • DRUG Sulfamethoxazole

Study Locations (9)

Other

  • Justus-Leibig University — Giessen
  • University of Milan — Milan
  • University of Geneva — Geneva

Florida

  • University of Miami — Miami

Massachusetts

  • Massachusetts General Hospital — Boston

Minnesota

  • University of Minnesota — Minneapolis

Missouri

  • Washington University — St Louis

Washington

  • Benaroya Research Institute at Virginia Mason Research Center — Seattle

Alberta

  • University of Alberta — Edmonton

Trial Details

FieldValue
Enrollment Target 36 participants
Start Date 2001-04
Est. Completion 2010-08
Phase Phase 2

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00014911

The ClinicalTrials.gov registry entry for NCT00014911 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 36 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 1,295 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Diabetes Mellitus, Insulin-Dependent appearing as the primary indexed condition, and to 5 interventions — of which Sirolimus is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT00014911 reports 9 study locations spanning 7 distinct geographic areas — top geographies include Other, Florida, Massachusetts. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT00014911 about?

NCT00014911 is a clinical study titled "Islet Transplantation for Type 1 Diabetes". The purpose of this study is to test whether the islet cell transplantation procedures and results from a previous study in Edmonton, Canada, can be repeated. The study also is designed to learn more about diabetes control using islet cell transplantation. This is a Phase I/II study (a study that e...

What is the current status of trial NCT00014911?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 36 participants. The study started on 2001-04. Estimated completion is 2010-08.

What conditions does trial NCT00014911 study?

This clinical trial studies the following conditions: Diabetes Mellitus, Insulin-Dependent. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT00014911?

The interventions under investigation include: Sirolimus (DRUG), Tacrolimus (DRUG), Daclizumab (DRUG), Islet Transplantation (PROCEDURE), Sulfamethoxazole (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT00014911?

This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 1,295 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT00014911 being conducted?

This trial has 9 study locations across Florida, Massachusetts, Minnesota, Missouri, Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial