Phase 2 N=9 Treatment

G-CSF and AMD3100 to Mobilize Stem Cells in Healthy Volunteers

Healthy

Bottom Line

View on ClinicalTrials.gov: NCT00082329 ↗

Enrolled (actual)

Serious AEs

11.1%

Results posted

May 2014

Primary outcome: Primary: Number of Participants With Successful Apheresis Collection Following Combination of AMD3100 and G-CSF. — 8; 1 participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: AMD 3100 (Mozobil plerixafor) (Drug); Granulocyte colony-stimulating factor (G-CSF) (Drug)
Age: Adult · 18+ yrs
Sex: All
Sponsor: National Heart, Lung, and Blood Institute (NHLBI)
Primary completion: Oct 2012

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With Successful Apheresis Collection Following Combination of AMD3100 and G-CSF.	8; 1	—
SECONDARY Average Fold Change From Baseline of Mobilized Cells Following G-CSF and AMD3100 to Mobilize Stem Cells in Healthy Volunteers	9.3; 3.8; 11.9; 6.6	—
SECONDARY Number of Participants With Increased the Levels of Circulating Hematopoietic Progenitor Cells, Immune Cells, and Other Cellular Subsets Collected by Apheresis.	8	—

Summary

This 12-day study will test whether the combination of G-CSF (granulocyte-colony stimulating factor) and AMD3100 (Mozobil) is more efficient in mobilizing stem cells for collection than the use of G-CSF alone. Traditionally, the growth factor G-CSF has been given to stem cell donors to mobilize, or push, stem cells out of the bone marrow and into the blood circulation for collection for transplantation. Although a sufficient quantity of cells usually can be collected with G-CSF treatment, some donors do not respond well and may require multiple apheresis procedures (see below) to collect enough cells. Studies indicate that G-CSF used together with a drug called AMD3100 may be more effective in mobilizing stem cells for collection than G-CSF alone. The Food and Drug Administration has approved G-CSF for stem cell mobilization. AMD3100 is a new drug that also mobilizes stem cells in large numbers within a few hours. Normal healthy volunteers between 18 and 60 years of age may be eligible for this study.

Eligibility Criteria

INCLUSION CRITERIA:

Healthy volunteers greater or equal to 18 years old, less than or equal to 60 years.

Weight greater than 60 kg (132 pounds)

Normal renal function: creatinine less than 1.5 mg/dl l

Normal liver function: bilirubin less than1.5mg/dl, transaminases within normal limit

Normal blood count: white blood cell (WBC) 3000-10000/mm3, granulocytes greater than 1500/mm3, platelets greater than 150,000/mm3, hemoglobin greater than 12.5g/dl

Subject must be eligible for normal blood donation and fit to undergo apheresis procedure (antecubital veins must be adequate for peripheral access during apheresis)

Ability to comprehend the investigational nature of the study and provide informed consent

EXCLUSION CRITERIA: any of the following

Active infection or history of recurrent infection or positive test for syphilis (RPR), hepatitis B and C (HBaSAg, Anti-HCV), HIV and human T- Lymphocytic virus (HTLV-1)

History of autoimmune disease such as rheumatoid arthritis, systemic lupus erythematous

History of cancer within the past 5 years excluding basal cell or squamous cell carcinoma of the skin

History of any hematologic disorders including thromboembolic disease

History of cardiac disease such as uncontrolled hypertension, peripheral vascular disease, myocardial infarction, cardiac arrhythmias or related symptoms such as tachycardia, chest pain, shortness of breath which have required medical intervention or treatment or a Framingham coronary disease risk prediction score of greater than 10% 10 year coronary heart disease (CHD) risk

History of heavy smoking with underlying pulmonary disease

History of cerebrovascular disease, transient ischemic attack, or stroke

Diagnosis of sickle cell anemia or sickle cell trait (to be screened by hemoglobin (Hbg) electrophoresis)

Pregnant or lactating

Severe psychiatric illness: mental deficiency sufficiently severe as to make informed consent impossible.

Mobilization with G-CSF within 90 days of protocol enrollment.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00082329). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.