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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: Completed Phase 1 study of Type 1 Diabetes, sponsored by University of Pittsburgh.
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 767-participant average among 198 other Type 1 Diabetes trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
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
Interventions
- BIOLOGICAL Diabetes-suppressive dendritic cell vaccine
- BIOLOGICAL control dendritic cells
Study Locations (1)
Pennsylvania
- University of Pittsburgh Medical Center - Pittsburgh
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2007-03 |
| Est. Completion | 2016-02 |
| Phase | Phase 1 |
What the finished NCT00445913 record still lists
NCT00445913 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 767-participant average among 198 other Type 1 Diabetes trials with a reported enrollment target (99% lower).
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 a single indexed study location in 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.
Where NCT00445913's enrollment target sits among peer trials
10 182nd of 198 higher than 9 of 198 other Type 1 Diabetes trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Type 1 Diabetes 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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