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

NCT03182426 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2024-07-19

No results posted yet for this study

Summary

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.

Conditions

  • Diabetes Mellitus, Type 1

Interventions

DRUG

Plerixafor

Systemic CD34+ stem cell mobilization for beta-cell repair

DRUG

Alemtuzumab

T-cell depletion

DRUG

Anakinra

Anti-inflammatory

DRUG

Etanercept

Anti-inflammatory

DRUG

Liraglutide

Beta-cell regeneration

Sponsors & Collaborators

  • Alberta Innovates Health Solutions

    collaborator OTHER

  • University of Alberta

    lead OTHER

Principal Investigators

  • James Shapiro, MD, PhD · University of Alberta

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2017-08-15
Primary Completion
2024-07-15
Completion
2024-07-15

Countries

  • Canada

Study Locations

More Related Trials

Entities

Drugs

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 NCT03182426 on ClinicalTrials.gov