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Protocol Details

Use of Granulocyte Colony Stimulating Factor (G-CSF) Mobilized Leukapheresis Collections from Healthy Volunteers to Develop Improved Methods of Stem Cell and Lymphocyte Selection for Allogeneic Transplantation

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

96-H-0049

Sponsoring Institute

National Heart, Lung and Blood Institute (NHLBI)

Recruitment Detail

Type: Participants currently recruited/enrolled
Gender: Male & Female
Min Age: 18 Years
Max Age: 60 Years

Referral Letter Required

No

Population Exclusion(s)

Children

Keywords

G-CSF;
Donor Apheresis;
Graft Versus Host Disease;
graft versus leukemia;
Natural History

Recruitment Keyword(s)

Normal Volunteer

Condition(s)

Graft-Versus-Host Disease;
Graft-versus-leukemia;
Donor Apheresis

Investigational Drug(s)

None

Investigational Device(s)

None

Intervention(s)

Drug: G-CSF

Supporting Site

National Heart, Lung, and Blood InstituteNew York University and New York Genome Center

Bone marrow transplants (BMT) are one form of treatment for disorders of the blood, including leukemia. However, because the procedure is often associated with potentially life-threatening reactions, it is usually reserved for patients with serious illnesses under the age of 60 years old.

One serious reaction complicating bone marrow transplants is referred to as graft-versus-host disease (GVHD). GVHD is a potentially fatal incompatibility reaction. The reaction is caused by antigens found on the cells of the patient that are not present on the cells of the donor. The antigens are recognized by transplanted white blood cells (lymphocytes). These lymphocytes begin attacking the recipient s cells and tissues and may lead to death.

In order to avoid GVHD, researchers have developed a technique using peripheral blood instead of bone marrow that allows transplantation of stem cells and removal of lymphocytes. Stem cells are the cells responsible for returning blood cell production to normal. Lymphocytes are the white blood cells that can cause GVHD.

The technique requires two steps. In the first step blood cells are collected from donors who have received doses of a growth factor. The growth factor (granulocyte colony stimulating factor) is designed to increase the production of donor stem cells.

In the second step white blood cell lymphocytes are removed from the collected blood, leaving only the stem cells.

The main goal of this study is to develop and improve the method of processing cells that are collected after stimulation with growth factor (G-CSF), by removing the white blood cell lymphocytes which can cause graft-versus-host disease (GVHD) while keeping the stem cells necessary for healthy blood cell building. In addition, researchers are interested in studying whether giving G-CSF has an effect on lymphocyte function, which may influence the immune reactions occurring in bone marrow transplantation.

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Eligibility

INCLUSION CRITERIA:

Healthy individual aged between 18 and 60 years.

No active infection or history of recurrent infection.

Normal renal function: creatinine less than 1.5 mg/dL, proteinuria less than 1+.

Normal liver function: bilirubin less than 1.5 mg/dL, transaminase less than 1.5- fold upper limit of normal

Normal blood count: WBC 3,000-10,000/microliter, ANC >1,500/microliter, platelets >150,000/microliter, hemoglobin >12.5g/dL.

Normal cardiovascular function, no history of chest pain, myocardial infarction, peripheral vascular disease, transient ischemic attack, or stroke.

Healthy female subjects of childbearing age should have a negative serum pregnancy test within one week of beginning G-CSF administration.

Female subjects should not be lactating.

Subject must be eligible for normal blood donation. He or she must be tested negative for syphilis (RPR), hepatitis B and C (HBsAg, Anti-HBc, Anti-HCV), HIV, HTLV-1, West Nile virus, T. Cruzi and Babesia test.

Subject must be able to comprehend the investigational nature of the study and provide informed consent to participate in the protocol.

Antecubital veins must be adequate for peripheral access during apheresis. Potential participants must be screened by an apheresis nurse to check venous access before protocol entry.

EXCLUSION CRITERIA:

Active viral, bacterial, fungal or parasite infection.

Female with positive pregnancy test or lactating.

History of autoimmune disease such as rheumatoid arthritis, systemic lupus erythematosus.

History of cancer excluding squamous carcinoma of the skin.

History of any hematologic disorders.

History of cardiovascular disease or related symptoms such as chest pain, shortness of breath, history of cerebrovascular disease.

Any positive serum screening test as listed in eligibility.

Allergy to G-CSF or bacterial E coli products.

Administration of NSAID within 10 days of starting protocol.

History of G-CSF administration and leukapheresis within past 3 months.


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Citations:

Peripheral blood stem cells for allo grafting

Optimizing dose and scheduling of filgrastim (G-CSF) for mobilization and collection of peripheral blood progenitor cells in normal volunteers

Positive selection of CD34+ hematopoietic cells using an immunoaffinity column results in T cell depletion equivalent to elutriation

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Contacts:

Principal Investigator

Referral Contact

For more information:

Andre Larochelle, M.D.
National Heart, Lung and Blood Institute (NHLBI)
NIHBC 10 - CRC BG RM 5-5132
10 CENTER DR
BETHESDA MD 20892
(301) 451-7139
larochea@nhlbi.nih.gov

Richard A. Gustafson
National Heart, Lung and Blood Institute (NHLBI)
National Institutes of Health
Building 10
Room 5-1424
10 Center Drive
Bethesda, Maryland 20892
(301) 402-5822
richard.gustafson@nih.gov

Office of Patient Recruitment
National Institutes of Health Clinical Center (CC)
Building 61, 10 Cloister Court
Bethesda, Maryland 20892
Toll Free: 1-800-411-1222
Local Phone: 301-451-4383
TTY: TTY Users Dial 7-1-1
ccopr@nih.gov

Clinical Trials Number:

NCT00001529

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