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NCT01210664 · ClinicalTrials.gov registry record · Phase 1
T1DM Immunotherapy Using CD4+CD127lo/-CD25+ Polyclonal Tregs
A Phase 1 study of Type 1 Diabetes Mellitus, sponsored by University of California, San Francisco.
- Completed
- Registry status
- Phase 1
- Development phase
- 16
- Enrollment target
- 2
- Study locations
NCT01210664: Completed Phase 1 study of Type 1 Diabetes Mellitus, sponsored by University of California, San Francisco.
NCT01210664 is a Phase 1 study of Type 1 Diabetes Mellitus that has completed, run by University of California, San Francisco. The registered enrollment target is 16 participants, below the 172-participant average among 112 other Type 1 Diabetes Mellitus trials with a reported enrollment target (91% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01210664, a Phase 1 study of Type 1 Diabetes Mellitus, has completed, sponsored by University of California, San Francisco.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 16 participants
- Enrollment target
- 2
- Study locations
Study Summary
The investigational therapy under study in this trial, regulatory T cells (Tregs), offers the hope of stabilizing further destruction of insulin producing beta cells in type 1 diabetes. Tregs are a specialized subset of T cells that function to control the immune response. Pre-clinical studies in non-obese diabetic mice have demonstrated that adoptive transfer of Tregs can slow diabetes progression and, in some cases, reverse new onset diabetes. The primary purpose of this Phase 1 study is to assess the safety and feasibility of intravenous infusion of ex vivo selected and expanded autologous polyclonal Tregs in patients with type 1 diabetes (T1DM) to support dose selection for a future efficacy trial. The study also aims to assess the effect of Tregs on beta cell function as well as on other measures of diabetes severity and the autoimmune response underlying T1DM.
Primary Outcome
The number of AEs are reported by cohort and severity.
Conditions Studied
Interventions
- BIOLOGICAL Ex vivo Expanded Human Autologous Polyclonal Regulatory T Cells
Study Locations (2)
California
- University of California, San Francisco Medical Center - San Francisco
Connecticut
- Yale University - New Haven
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2010-11 |
| Est. Completion | 2017-01 |
| Phase | Phase 1 |
What the finished NCT01210664 record still lists
NCT01210664 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 16 participants, a relatively small participant target, below the 172-participant average among 112 other Type 1 Diabetes Mellitus trials with a reported enrollment target (91% lower).
The record links to 1 condition, with Type 1 Diabetes Mellitus appearing as the primary indexed condition, and to 1 intervention - of which Ex vivo Expanded Human Autologous Polyclonal Regulatory T Cells is the first listed.
NCT01210664 reports a single indexed study location in California, Connecticut.
Frequently Asked Questions
What is clinical trial NCT01210664 about?
NCT01210664 is a clinical study titled "T1DM Immunotherapy Using CD4+CD127lo/-CD25+ Polyclonal Tregs". The investigational therapy under study in this trial, regulatory T cells (Tregs), offers the hope of stabilizing further destruction of insulin producing beta cells in type 1 diabetes. Tregs are a specialized subset of T cells that function to control the immune response. Pre-clinical studies in no...
What is the current status of trial NCT01210664?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 16 participants. The study started on 2010-11. Estimated completion is 2017-01.
What conditions does trial NCT01210664 study?
This clinical trial studies the following conditions: Type 1 Diabetes Mellitus.
What interventions are being tested in trial NCT01210664?
The interventions under investigation include: Ex vivo Expanded Human Autologous Polyclonal Regulatory T Cells (BIOLOGICAL).
Who is sponsoring clinical trial NCT01210664?
This trial is sponsored by University of California, San Francisco, which has 1,713 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01210664 being conducted?
This trial has 2 study locations across California, Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Type 1 Diabetes Mellitus
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 NCT01210664's enrollment target sits among peer trials
16 97th of 112 higher than 12 of 112 other Type 1 Diabetes Mellitus trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Type 1 Diabetes Mellitus 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.
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