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Autologous Immunoregulatory Dendritic Cells for Type 1 Diabetes Therapy

NCT02354911 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2024-02-20

No results posted yet for this study

Summary

The purpose of this study is to determine whether dendritic cells collected via leukapheresis and incubated with antisense DNA oligonucleotides and then injected back into the same subject will serve as modulators of the immune system in a manner that disrupts the autoimmune process responsible for the destruction of pancreatic beta cells in subjects with new onset type 1 diabetes.

Conditions

Interventions

BIOLOGICAL

Immunoregulatory Dendritic Cells

Autologous dendritic cells harvested by leukapheresis and engineered ex vivo via incubation with antisense DNA oligonucleotides targeting the primary transcripts of CD40, CD80 and CD86. The ex vivo engineered product is then administered via blinded intradermal injection in the peri-umbilical region of the abdomen given as 4 separate injections at 2-week intervals (\~10 million cells/injection).

OTHER

Placebo Comparator: Placebo Control

Blinded intradermal injections in the peri-umbical region of the abdomen given as 4 separate injections at 2-week intervals

Sponsors & Collaborators

  • West Penn Allegheny Health System

    collaborator OTHER

  • University of Pittsburgh Medical Center

    collaborator OTHER

  • Stanford University

    collaborator OTHER

  • University of Miami

    collaborator OTHER

  • DiaVacs, Inc.

    lead INDUSTRY

Principal Investigators

  • Massimo Trucco, PhD · Institue of Cellular Therapeutics, Allegheny General Hospital, Pittsburgh, PA

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
12 Years
Max Age
35 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-10-31
Primary Completion
2024-02-16
Completion
2024-02-16

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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 NCT02354911 on ClinicalTrials.gov