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NCT00306098 · ClinicalTrials.gov registry record · Phase 2

Islet Cell Transplantation Alone in Patients With Type 1 Diabetes Mellitus: Steroid-Free Immunosuppression

A Phase 2 study, sponsored by Rodolfo Alejandro.

Completed
Registry status
Phase 2
Development phase
26
Enrollment target

NCT00306098 is a Phase 2 study that has completed, run by Rodolfo Alejandro. The registered enrollment target is 26 participants.

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The verdict

NCT00306098, a Phase 2 study, has completed, sponsored by Rodolfo Alejandro.

COMPLETED
Registry status
Phase 2
Development phase
26 participants
Enrollment target

Study Summary

SPECIFIC AIMS: 1. To reverse hyperglycemia and insulin dependency in patients with Type 1 Diabetes Mellitus by islet cell transplantation; 2. To eliminate the incidence of hypoglycemia coma and unawareness in patients with Type 1 Diabetes Mellitus by islet cell transplantation; 3. To assess long-term safety and function of successful islet cell transplants in patients with Type 1 Diabetes Mellitus; 4. To determine whether the natural history of the microvascular, macrovascular and neuropathic complications of Diabetes Mellitus are altered following successful transplantation of islet cells; and 5. To assess the effect of infliximab in preventing early islet destruction, and thereby eliminating the need for a second donor's islet cells. 6. To assess the effect of etanercept in preventing early islet destruction. 7. To assess the effect of exenatide to improve islet graft function and survival in subjects that have returned to using exogenous insulin. 8. To assess the ability of exenatide to improve islet survival at time of transplantation.

Interventions

  • DRUG islets

Trial Details

FieldValue
Enrollment Target 26 participants
Start Date 2000-12
Est. Completion 2004-07-04
Phase Phase 2

Sponsor

Rodolfo Alejandro

10 total trials

What the Registry Record Tells You About NCT00306098

The ClinicalTrials.gov registry entry for NCT00306098 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 26 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Rodolfo Alejandro, which has 10 total studies on file at ClinicalTrials.gov.

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

NCT00306098 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00306098 about?

NCT00306098 is a clinical study titled "Islet Cell Transplantation Alone in Patients With Type 1 Diabetes Mellitus: Steroid-Free Immunosuppression". SPECIFIC AIMS: 1. To reverse hyperglycemia and insulin dependency in patients with Type 1 Diabetes Mellitus by islet cell transplantation; 2. To eliminate the incidence of hypoglycemia coma and unawareness in patients with Type 1 Diabetes Mellitus by islet cell transplantation; 3. To assess long-te...

What is the current status of trial NCT00306098?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 26 participants. The study started on 2000-12. Estimated completion is 2004-07-04.

What interventions are being tested in trial NCT00306098?

The interventions under investigation include: islets (DRUG).

Who is sponsoring clinical trial NCT00306098?

This trial is sponsored by Rodolfo Alejandro, which has 10 total clinical trials registered on ClinicalTrials.gov.

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

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.