CompletedPhase 2

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

United States9 participantsStarted 2004-06-18

Plain-language 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.

Who can participate

Age range

18 Years – 60 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

* 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 predicti…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of Participants With Successful Apheresis Collection Following Combination of AMD3100 and G-CSF.

Timeframe: Day 1 (cells are counted 24 hours after AMD3100)

Trial details

NCT IDNCT00082329

SponsorNational Heart, Lung, and Blood Institute (NHLBI)

Sponsor typeNIH

Study typeINTERVENTIONAL

Primary completion2012-10-25

Results submitted2014-04-01

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