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T1DM Immunotherapy Using CD4+CD127lo/-CD25+ Polyclonal Tregs

NCT01210664 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2018-07-11

Study results available
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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

  • Type 1 Diabetes Mellitus

Interventions

BIOLOGICAL

Ex vivo Expanded Human Autologous Polyclonal Regulatory T Cells

The researchers will multiply/expand the Tregs in the laboratory using anti-CD3/anti-CD28 coated beads plus IL-2. Then, the Tregs will be infused back into the patient in a single infusion. The first cohort will receive 0.05 x10\^8 cells. The second cohort will receive 0.4 x10\^8 cells. The third cohort will receive 3.2 x10\^8 cells. The fourth cohort will receive 26 x10\^8 cells.

Sponsors & Collaborators

Principal Investigators

  • Stephen E Gitelman, MD · University of California, San Francisco

  • Jeffrey Bluestone, PhD · University of California, San Francisco

  • Kevan Herold, MD · Yale University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-11-30
Primary Completion
2016-12-31
Completion
2017-01-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01210664 on ClinicalTrials.gov