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

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 |

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

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
Italy | |
Policlinico Universitario, Azienda Ospedaliera di Padova | |
Padova, Italy, 35128 |
Responsible Party: | University of Padova |
ClinicalTrials.gov Identifier: | NCT02056210 |
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 |
Stem cells Bone marrow |
Plerixafor octahydrochloride Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents |