Stem Cell Mobilization With Plerixafor in Diabetic vs Control Subjects

• Status: Completed
• Trial end date: 2014-10-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Padova
• Collaborator: Azienda Ospedaliera di Padova
• Treatments: JM 3100; Plerixafor

Criteria

Inclusion criteria:

• 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.

Exclusion criteria:

• 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;

• Known hypersensitivity to Mozobil or its excipients;

• Refusal / inability to provide informed consent.

• women with childbearing potential can participate to this trial just if are using effective oral contraception; a negative pregnancy test is required before study entry). Women will be asked to continue oral contraception for 3 months after Mozobil administration.

All antidiabetic medications are allowed.