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Stem Cell Mobilization With Plerixafor in Diabetic vs Control Subjects

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ClinicalTrials.gov Identifier: NCT02056210
Recruitment Status : Completed
First Posted : February 5, 2014
Last Update Posted : October 24, 2014
Sponsor:
Collaborator:
Azienda Ospedaliera di Padova
Information provided by (Responsible Party):
University of Padova

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

Condition or disease Intervention/treatment Phase
Diabetes Drug: Mozobil Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Mobilization Test of BM Progenitor Cells With Plerixafor / AMD3100: Controlled Parallel Group Comparison Between Diabetic and Non Diabetic Subjects
Study Start Date : February 2014
Actual Primary Completion Date : October 2014
Actual Study Completion Date : October 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Plerixafor

Arm Intervention/treatment
Experimental: Stem cell mobilization in diabetic patients
Injection of Mozobil (Plerixafor / AMD3100) in diabetic patients
Drug: Mozobil
Subcutaneous injection of 0.24 mg/kg Mozobil once at 8:30am
Other Names:
  • Plerixafor
  • AMD3100

Experimental: Stem cell mobilization in non diabetic subjects
Injection of Mozobil (Plerixafor / AMD3100) in non diabetic subjects
Drug: Mozobil
Subcutaneous injection of 0.24 mg/kg Mozobil once at 8:30am
Other Names:
  • Plerixafor
  • AMD3100




Primary Outcome Measures :
  1. CD34+ stem cell mobilization in diabetic vs non diabetic subjects [ Time Frame: 6 hours ]

    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).



Secondary Outcome Measures :
  1. CD34+ stem cell mobilization within diabetic patients [ Time Frame: 6 hours ]

    to evaluate whether Mozobil monotherapy is able to induce a significant CD34+ stem cells mobilization in diabetic patients (intra-group comparison).

    Clinical response variable: detection of a significant fold-change in CD34+ peripheral cell count versus baseline in diabetic patients.


  2. EPC (endothelial progenitor cell) mobilization in diabetic vs non diabetic subjects [ Time Frame: 6 hours ]

    To evaluate the differences in mobilization of EPC (CD34+KDR+) from the bone marrow to the peripheral blood induced by a single sc injection of Mozobil in diabetic patients versus non diabetic controls (inter-group comparison).

    Clinical response variable: comparison of the fold change in CD34+ KDR+ peripheral cell count in diabetic versus non diabetic controls after Mozobil administration (with collection of safety and tolerability data).


  3. EPC (endothelial progenitor cell) mobilization within diabetic patients [ Time Frame: 6 hours ]

    To evaluate whether Mozobil monotherapy is able to induce a significant EPC mobilization in diabetic patients (intra-group comparison).

    Clinical response variable: detection of a significant fold-change in CD34+KDR+ peripheral cell count versus baseline in diabetic patients




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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02056210


Locations
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Italy
Policlinico Universitario, Azienda Ospedaliera di Padova
Padova, Italy, 35128
Sponsors and Collaborators
University of Padova
Azienda Ospedaliera di Padova

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Padova
ClinicalTrials.gov Identifier: NCT02056210     History of Changes
Other Study ID Numbers: MZBL-2996P/13
First Posted: February 5, 2014    Key Record Dates
Last Update Posted: October 24, 2014
Last Verified: October 2014

Keywords provided by University of Padova:
Stem cells
Bone marrow

Additional relevant MeSH terms:
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Plerixafor octahydrochloride
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents