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Stem Cell Mobilization With Plerixafor in Diabetic vs Control Subjects

NCT02056210 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2014-10-24

No results posted yet for this study

Summary

The objective of this study is to assess whether there are differences in the mobilization of CD34+ cells and EPC in response to Mozobil in patients with diabetes mellitus compared to subjects without diabetes. Currently, there are no non-invasive methods for the study of bone marrow function in humans. This project aims to evaluate in patients with type 1 or type 2 diabetes mellitus the ability to mobilize CD34+ cells and EPC from the bone marrow to the periphery in response to the exogenous mobilizing agent AMD3100 / plerixafor (Mozobil), compared with a group of non-diabetic individuals. While it has been recently shown that diabetic patients do not respond to mobilization induced by G-CSF (Filgrastim), the investigators herein hypothesize that diabetic patients can adequately respond to mobilization induced by Plerixafor

Conditions

Interventions

DRUG

Mozobil

Subcutaneous injection of 0.24 mg/kg Mozobil once at 8:30am

Sponsors & Collaborators

  • Azienda Ospedaliera di Padova

    collaborator OTHER

  • University of Padova

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-02-28
Primary Completion
2014-10-31
Completion
2014-10-31

Countries

  • Italy

Study Locations

More Related Trials

Entities

Diseases

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 NCT02056210 on ClinicalTrials.gov