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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 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 140-participant average among 105 other Type 1 Diabetes Mellitus trials with a reported enrollment target (89% lower). The trial reports 2 study locations across 2 states.

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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.

Conditions Studied

Type 1 Diabetes Mellitus

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

FieldValue
Enrollment Target 16 participants
Start Date 2010-11
Est. Completion 2017-01
Phase Phase 1

Sponsor

University of California, San Francisco

1,713 total trials

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What the Registry Record Tells You About NCT01210664

The ClinicalTrials.gov registry entry for NCT01210664 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 16 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 140-participant average among 105 other Type 1 Diabetes Mellitus trials with a reported enrollment target (89% lower). The listed sponsor is University of California, San Francisco, which has 1,713 total studies on file at ClinicalTrials.gov.

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 2 study locations spanning 2 distinct geographic areas - top geographies include 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.

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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.