Stem Cell Mobilization (Plerixafor) and Immunologic Reset in Type 1 Diabetes (T1DM)

NCT03182426 · Completed

Last updated 2026-05-28

This clinical trial tests whether a drug called plerixafor, which helps stem cells move from the bone marrow into the blood, can help reset the immune system in adults recently diagnosed with type 1 diabetes.

Status Completed The study has finished.

Phase Phase1, Phase2

Type Interventional (clinical trial)

Design Randomized, open-label (no blinding) treatment study

Participants 22 people

Who can join Ages 18–45 · all sexes

Timeline Started 2017-08 · est. completion 2024-07

Where 1 site · Canada

What this study is testing ClinicalTrials.gov NCT03182426 ↗

Description as written by the study sponsor.

Type 1 diabetes is an autoimmune disease characterized by destruction of pancreatic beta-cells, resulting in absolute deficiency of insulin. Presently there is no known cure. Our proposed interventional trial is based on 'immunological reset' approach: T-depletion therapy and anti-inflammatory treatment will restore self-tolerance in T1DM; Autologous, peripheral-blood mobilized hematopoietic CD34+-enriched stem cells and a long-acting GLP-1 analogue will promote pancreatic islet regeneration and repair. The short-term goals of this protocol is to demonstrate that subjects with new-onset T1DM undergoing autologous hematopoietic stem cell mobilization and immunologic reset will have greater preservation of endogenous insulin secretion compared to controls, and foremost that this nonmyeloablative treatment is safe, without the need for chronic immune suppression.

Treatments tested

Plerixafor also known as Mozobil Drug

Systemic CD34+ stem cell mobilization for beta-cell repair
Alemtuzumab also known as Lemtrada Drug

T-cell depletion
Anakinra also known as Kineret Drug

Anti-inflammatory
Etanercept also known as Enbrel Drug

Anti-inflammatory
Liraglutide also known as Victoza Drug

Beta-cell regeneration

Main thing measured	Change of 2-hour mixed meal stimulated C-peptide AUC
Sponsor	University of Alberta
Conditions studied	Diabetes Mellitus, Type 1
GLP-1 drugs	—

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT03182426 ↗