Bone Marrow Progenitor Cell Mobilization in Diabetes

• Status: Completed
• Trial end date: 2013-08-01
• Target enrollment: 0
• Participant gender: All

Summary

Diabetes mellitus is associated with a significant reduction of circulating progenitor cells (CPCs). These include endothelial progenitor cells (EPCs), which are involved in cardiovascular homeostasis and repair. A reduction of CPCs in metabolic patients is associated with an increased risk of future adverse cardiovascular outcomes. Therefore, ways to active stimulate an increase of CPC levels in diabetes are actively pursued.

Experimental animal studies and preliminary data in humans indicate that a bone marrow defect is causally related to the low CPC level in diabetes.

Our previous data in rats indicate that diabetes reduces the bone marrow responsiveness to granulocyte colony-stimulating factor (G-CSF) in terms of progenitor cell mobilization.

In the present study, we aim at investigating bone marrow responsiveness to pharmacological mobilization of CPC in diabetic patients as compared to non-diabetic subjects.

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

Details

• Lead Sponsor: University of Padova
• Treatments: Lenograstim

Criteria

Inclusion Criteria:

• Diabetes mellitus (for cases) or absence of diabetes (for controls);

• Age 25-65;

• Both sexes;

• Capability of providing informed consent.

Exclusion Criteria:

• Age <25 or >65;

• Fertile women;

• Recent (within 2 months) acute illnesses;

• Chronic immune of infectious diseases;

• Current or remote hematological disorders;

• Leukocytosis, leukopenia or thrombocytopenia;

• Organ transplantation or immune suppression;

• Altered liver function;

• Severe renal failure (eGFR<30 mL/min/m2);

• Anomalies in lymphocytes subpopulations;

• High basal level of CD34+ cell count;

• Allergy to Filgrastim;

• Bronchial asthma or other chronic lung disorders;

• Current or remote cancer;

• Deny or impossibility to provide informed consent.