NCT02056210

Brief 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_4 diabetes

Timeline
Completed

Started Feb 2014

Shorter than P25 for phase_4 diabetes

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2014

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

February 3, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 5, 2014

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
Last Updated

October 24, 2014

Status Verified

October 1, 2014

Enrollment Period

8 months

First QC Date

February 3, 2014

Last Update Submit

October 22, 2014

Conditions

Diabetes

Keywords

Stem cellsBone marrow

Outcome Measures

Primary Outcomes (1)

  • CD34+ stem cell mobilization in diabetic vs non diabetic subjects

    To evaluate the differences of CD34+ cells mobilization from the bone marrow to the peripheral blood induced by a single sc injection of Mozobil in diabetic patients versus non diabetic controls. Clinical response variable: comparison of the fold change in CD34+ peripheral cell count in diabetic versus non diabetic controls after Mozobil administration (with collection of safety and tolerability data).

    6 hours

Secondary Outcomes (3)

  • CD34+ stem cell mobilization within diabetic patients

    6 hours

  • EPC (endothelial progenitor cell) mobilization in diabetic vs non diabetic subjects

    6 hours

  • EPC (endothelial progenitor cell) mobilization within diabetic patients

    6 hours

Study Arms (2)

Stem cell mobilization in diabetic patients

EXPERIMENTAL

Injection of Mozobil (Plerixafor / AMD3100) in diabetic patients

Drug: Mozobil

Stem cell mobilization in non diabetic subjects

EXPERIMENTAL

Injection of Mozobil (Plerixafor / AMD3100) in non diabetic subjects

Drug: Mozobil

Interventions

MozobilDRUG

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

Also known as: Plerixafor, AMD3100
Stem cell mobilization in diabetic patientsStem cell mobilization in non diabetic subjects

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diabetes mellitus (type 1 or 2) (for the patients) or absence of diabetes mellitus and other carbohydrates metabolism alterations (for the non diabetic controls)
  • Age 20-65 years;
  • Both genders;
  • Informed consent.

You may not qualify if:

  • Age \<20 or \>65 years;
  • Pregnancy or lactation \*
  • Recent surgery or trauma;
  • Recent acute diseases (within 2 months from study entry);
  • Immune diseases (except from type I diabetes and autoimmune thyroiditis);
  • Chronic infectious diseases;
  • Hematologic malignancies either past or present;
  • Solid tumor known or strongly suspected;
  • Leukocytosis, leukopenia, or thrombocytopenia;
  • Solid organ transplant or immunosuppression;
  • Alteration of hepatic function (transaminases \>2 ULN);
  • Severe chronic diabetic micro- or macroangiopathy
  • HbA1c \>11%.
  • Deficit in renal function (eGFR\<50 ml/m2);
  • Significant abnormalities of the peripheral lymphocyte immunophenotype;
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Policlinico Universitario, Azienda Ospedaliera di Padova

Padua, 35128, Italy

Location

Related Publications (1)

  • Fadini GP, Fiala M, Cappellari R, Danna M, Park S, Poncina N, Menegazzo L, Albiero M, DiPersio J, Stockerl-Goldstein K, Avogaro A. Diabetes Limits Stem Cell Mobilization Following G-CSF but Not Plerixafor. Diabetes. 2015 Aug;64(8):2969-77. doi: 10.2337/db15-0077. Epub 2015 Mar 24.

    PMID: 25804941DERIVED

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

plerixafor

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 3, 2014

First Posted

February 5, 2014

Study Start

February 1, 2014

Primary Completion

October 1, 2014

Study Completion

October 1, 2014

Last Updated

October 24, 2014

Record last verified: 2014-10

Locations

IT(1)