Stem Cell Collection

Terminated

• Conditions: Stem Cells

• Registration Number: NCT00316069
• Lead Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Brief Summary

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 For this procedure, blood is withdrawn through a catheter (plastic tube) placed in a vein and directed into a machine where the white cells and stem cells are separated from the rest of the blood by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.

Detailed Description

Recent advances in the area of stem cell research suggest that redirected differentiation of stem cells may prove useful for the treatment of a variety of diseases including diabetes and other systemic diseases. In the hematopoietic system, recent studies have also demonstrated the ability of adult erythroid stem cells to undergo differentiation toward a fetal-like phenotype. This fetal-like phenotype is crucial in eliminating the clinical sequelae of sickle syndromes and beta hemoglobinopathies. However, additional studies are needed to determine if these results can be applied to patients with diseases involving hematopoietic stem cells or other blood cells. In addition, it is clear that the stem cells from separate donors do not possess identical properties of growth and differentiation.

The immediate aim of this protocol is to obtain hematopoietic stem cells from many human donors for examination of the biological properties of those cells. The study is also designed to determine if the donor-specific factors can influence the properties of their hematopoietic stem cells. Each volunteer will undergo stem cell mobilization after administration of granulocyte-colony stimulating factor (G-CSF) for five consecutive days followed by a large volume apheresis on the 5th day after G-CSF injection. The harvested product will be purified for the primitive hematopoietic progenitor cells and viably preserved in multiple aliquots. The cells will then be studied in-depth for a better understanding of their biological properties, growth and differentiation. Donor-specific information will be correlated with these research studies to identify factors that may assist with the understanding of adult stem cell biology.

Study Timeline

• Study Start: 2006-04-12
• Study First Submitted: 2006-04-18
• Study First Submitted QC: 2006-04-18
• Study First Posted: 2006-04-19
• Status Verified: 2017-08-02
• Study Completion: 2017-08-02
• Last Update Submitted: 2019-12-14
• Last Update Posted: 2019-12-17

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 429

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike; 🇺🇸 Bethesda, Maryland, United States