Stem Cell Collection

Stopped early

Conditions studied: Stem Cells

In brief

This study is designed for the collection of stem cells from the bloodstream for use in research studies. These cells will be studied to determine if they have unique features particular to the donor that may or may not affect their use for developing new treatments. Volunteers with or without a blood disease may be eligible to donate stem cells for this study. Women who are pregnant or breastfeeding may not enroll. Donors are evaluated with a medical history and physical examination, blood tests and an ultrasound examination of the spleen. They then undergo stem cell mobilization and apheresis as follows: Donors are given injections of a hormone called G-CSF every day for 5 days to stimulate release of stem cells from the bone marrow into the bloodstream for collection. On the day of the last injection, donors undergo apheresis to obtain white cells and stem cells. For this procedure, blood is withdrawn through a catheter (plastic tube) placed in a vein and directed into a machine where the white cells and stem cells are separated from the rest of the blood by a spinning process. These cells are extracted and collected in a bag inside the machine, and the rest of the blood is returned to the donor through a second catheter in a vein in the other arm. The procedure takes 4 to 5 hours.

Key facts

Study ID

NCT00316069

Run by

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

People needed

429

Starts

2006-04-12

Expected to finish

2017-08-02

Last updated by the study team

2019-12-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may not qualify if…

• Any concomitant condition or illness that will result in an inability to undergo G-CSF mobilization or apheresis listed below.
• Allergy to G-CSF or bacterial E. coli products.
• Autoimmune diseases, such as immune thrombocytopenic purpura, rheumatoid arthritis or systemic lupus erythematosus.
• Patients with active pulmonary disease.
• Significant cardiovascular disease or related symptoms such as chest pain, shortness of breath, or uncontrolled hypertension. If volunteers have heart conditions such as well-controlled arrhythmias, or mitral valve prolapse that does not require medication or restrictions, they will be allowed to enroll. If volunteers have elevated blood pressure that is well-controlled by medication or diet and if there is no associated heart disease, they will be allowed to enroll.
• Epilepsy: If volunteers have had more than one seizure in the past year, they will not be allowed to enroll. If volunteers have well-controlled epilepsy and have had no seizures in the past year, they will be allowed to enroll.
• Active infections.
• Pregnant and lactating women.
• Splenomegaly: Patients having splenic diameters greater than 13.0 cm at the time of initial assessment will be excluded from the protocol.
• Sickle cell disease.

Where it is running

• National Institutes of Health Clinical Center, 9000 Rockville Pike — Bethesda, Maryland, United States

Full record on ClinicalTrials.gov

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