Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

NCT00445913 · ClinicalTrials.gov registry record · Phase 1

Autologous Dendritic Cell Therapy for Type 1 Diabetes Suppression: A Safety Study

A Phase 1 study of Type 1 Diabetes, sponsored by University of Pittsburgh.

Completed
Registry status
Phase 1
Development phase
10
Enrollment target
1
Study location

NCT00445913 is a Phase 1 study of Type 1 Diabetes that has completed, run by University of Pittsburgh. The registered enrollment target is 10 participants, below the 824-participant average among 178 other Type 1 Diabetes trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state.

View on ClinicalTrials.gov ↗

View your shortlist →

The verdict

NCT00445913, a Phase 1 study of Type 1 Diabetes, has completed, sponsored by University of Pittsburgh.

COMPLETED
Registry status
Phase 1
Development phase
10 participants
Enrollment target
1
Study location

Study Summary

The proposed studies describe a randomized trial to evaluate the safety of a new diabetes-suppressive cell vaccine, consisting of autologous monocyte-derived dendritic cells treated ex vivo with antisense phosphorothioate-modified oligonucleotides targeting the primary transcripts of the CD40, CD80 and CD86 co-stimulatory molecules (immunoregulatory DC; iDC). The hypothesis to be tested in this study is that iDC are safe and without toxicity in established type 1 diabetic patients. Fifteen (15) individuals exhibiting fully-established, insulin-dependent type 1 diabetics, without any diabetes-related complications, infectious disease, or other medical anomaly, will be enrolled to establish safety of the approach. 7/15 volunteers will be administered autologous control dendritic cells and 8/15 will be administered iDC. The study is anticipated to be complete by twelve (12) months. Currently, other than a humanized anti-CD3 antibody with considerable side effects, there is no other means to reverse new-onset type 1 diabetes. These studies will be the first ever to employ autologous dendritic cell transfer to suppress an autoimmune disease and to perhaps reverse it early on in the clinical process.

Conditions Studied

Type 1 Diabetes

Interventions

  • BIOLOGICAL Diabetes-suppressive dendritic cell vaccine
  • BIOLOGICAL control dendritic cells

Study Locations (1)

Pennsylvania

  • University of Pittsburgh Medical Center - Pittsburgh

Trial Details

FieldValue
Enrollment Target 10 participants
Start Date 2007-03
Est. Completion 2016-02
Phase Phase 1

Sponsor

University of Pittsburgh

1,238 total trials

Interested in This Trial?

Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00445913

The ClinicalTrials.gov registry entry for NCT00445913 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 10 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 824-participant average among 178 other Type 1 Diabetes trials with a reported enrollment target (99% lower). The listed sponsor is University of Pittsburgh, which has 1,238 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Type 1 Diabetes appearing as the primary indexed condition, and to 2 interventions - of which Diabetes-suppressive dendritic cell vaccine is the first listed.

NCT00445913 reports 1 study location spanning 1 distinct geographic area - top geographies include Pennsylvania.

Frequently Asked Questions

What is clinical trial NCT00445913 about?

NCT00445913 is a clinical study titled "Autologous Dendritic Cell Therapy for Type 1 Diabetes Suppression: A Safety Study". The proposed studies describe a randomized trial to evaluate the safety of a new diabetes-suppressive cell vaccine, consisting of autologous monocyte-derived dendritic cells treated ex vivo with antisense phosphorothioate-modified oligonucleotides targeting the primary transcripts of the CD40, CD80 ...

What is the current status of trial NCT00445913?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 10 participants. The study started on 2007-03. Estimated completion is 2016-02.

What conditions does trial NCT00445913 study?

This clinical trial studies the following conditions: Type 1 Diabetes.

What interventions are being tested in trial NCT00445913?

The interventions under investigation include: Diabetes-suppressive dendritic cell vaccine (BIOLOGICAL), control dendritic cells (BIOLOGICAL).

Who is sponsoring clinical trial NCT00445913?

This trial is sponsored by University of Pittsburgh, which has 1,238 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00445913 being conducted?

This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Type 1 Diabetes

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Explore more on PlainTrial

Type 1 Diabetes

All registered trials for this condition

Pennsylvania

All trials with a study site in Pennsylvania

Recruiting now

Find trials open to new participants near you

Rankings

Top sponsors, conditions, and phases

Read our methodology - how this data is sourced, computed, and verified.

Related

Browse all → | Rankings →
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.