Stem Cell Collection for Adult Volunteers

NCT00033774 | Terminated

• 2 other identifiers: 02016002-H-0160
• Study Type: observational
• Target: 136
• Locations: 1 country
• Sites: 1

Brief Summary

This study will examine the development of stem cells (very immature cells produced by the bone marrow) and their potential to change into cells of other organ types. These cells will be studied for their potential use in creating replacement tissue for diseases ranging from diabetes to Parkinson s. Healthy volunteers 18 years of age or older may be eligible for this study. Candidates will be screened with a medical history, physical examination, and blood tests. Participants will undergo a process called 'stem cell mobilization and apheresis' to collect bone marrow stem cells. For five days before the collection they will receive injections of a hormone called G-CSF, which stimulates release of stem cells from the bone marrow into the bloodstream. On the fifth day of the injections, stem cells will be collected through apheresis. For this procedure, blood is collected through a catheter (plastic tube) placed in an arm vein and directed into a cell separator machine. There, the white cells and stem cells are separated from the other blood components through a spinning process and collected in a bag inside the machine. The rest of the blood is returned to the donor through a catheter in the other arm.

Conditions

Sickle Cell

Keywords

Leukapheresis; G-CSF; Mobilization; Stem Cells; Adult; Natural History; Healthy Volunteer; HV; Normal Control

Outcome Measures

Primary Outcomes (1)

• Collection of peripheral blood stem cells via standard leukapheresis

  To explore the control of normal differentiation of adult hematopoietic stem cells collected from the peripheral blood after G-CSF mobilization.

  5 days

Study Arms (1)

1

Eligible healthy volunteers 18 and older

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Recruitment will occur from a pool of normal volunteers. Volunteers who are not undergoing pretreatment with G-CSF will receive two hundred and fifty (250) dollars for the leukapheresis. Volunteers who undergo pretreatment with G-CSF will receive a payment of five hundred (500) dollars upon completion of 5 days of G-CSF, blood draws, and the leukapheresis. In the event of early withdrawal from the study before the leukapheresis, the volunteer will receive fifty (50) dollars for each visit to the hospital which includes blood draws and G-CSF administration.

You may qualify if:

• Age 18 or greater.
• Normal renal function: creatinine less than1.5 mg/dL, proteinuria less than1+.
• Normal liver function: bilirubin less than 2.5 mg/dL, ALT less than 2.5 times the upper limit of normal, all other transminases less than 2.5 times the upper limit of normal.
• Normal blood counts: WBC 3,000-10,000/mm3, granulocytes greater than 1,500/mm3, platelets greater than 150,000/mm3, hemoglobin greater than 12.5g/dL, MCV within normal limits.
• Female volunteers of childbearing age should have a negative serum pregnancy test within one week of beginning G-CSF administration.
• Meets NIH Department of Transfusion Medicine (DTM) eligibility criteria for blood component donation for in vitro research use (negative serologic tests for syphilis, hepatitis B and C, HIV, and HTLV-1).
• Ability to give informed consent to participate in the protocol.

You may not qualify if:

• Any underlying hematologic disorder including sickle cell disease.
• Active viral, bacterial, fungal, or parasitic infection.
• History of autoimmune disease, such as rheumatoid arthritis or systemic lupus erythematosus.
• History of cancer excluding squamous carcinoma of the skin and cervical carcinoma in situ.
• History of cardiovascular disease or related symptoms such as chest pain or shortness of breath.
• Any positive serum screening test as listed below.
• Allergy to G-CSF or bacterial E. coli products.

Sponsors & Collaborators

• National Heart, Lung, and Blood Institute (NHLBI): lead

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• Wei G, Schubiger G, Harder F, Muller AM. Stem cell plasticity in mammals and transdetermination in Drosophila: common themes? Stem Cells. 2000;18(6):409-14. doi: 10.1634/stemcells.18-6-409.

  PMID: 11072028 BACKGROUND

• Orkin SH. Diversification of haematopoietic stem cells to specific lineages. Nat Rev Genet. 2000 Oct;1(1):57-64. doi: 10.1038/35049577.

  PMID: 11262875 BACKGROUND

• Lemischka I. Stem cell dogmas in the genomics era. Rev Clin Exp Hematol. 2001 Mar;5(1):15-25. doi: 10.1046/j.1468-0734.2001.00030.x.

  PMID: 11486729 BACKGROUND

Related Links

• NIH Clinical Center Detailed Web Page

Biospecimen

Retention: SAMPLES WITH DNA

stem cells

Study Officials

• John F Tisdale, M.D.

  National Heart, Lung, and Blood Institute (NHLBI)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 9, 2002
• First Posted: April 10, 2002
• Study Start: April 29, 2002
• Primary Completion: June 27, 2022
• Study Completion: August 19, 2022
• Last Updated: August 25, 2022

Record last verified: 2022-08

Locations

US (1)