Protocol Number: 96-H-0049

Title:

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

Number:

96-H-0049

Summary:

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.

Sponsoring Institute:

National Heart, Lung and Blood Institute (NHLBI)

Recruitment Detail

Type: Participants currently recruited/enrolled

Gender: Male & Female

Referral Letter Required: Yes

Population Exclusion(s): Children

Eligibility Criteria:

INCLUSION CRITERIA:

Normal 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 within normal limit.

Normal blood count: WBC 3000 to 10,000/mm(3), granulocytes greater than 1500/mm(3), platelets greater than 150,000/mm(3), hemoglobin greater than 12.5 g/dl, MCV and MCHC normal.

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

Normal 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 and HTLV 1.

Subject can participate no more than 3 times. Each time must be at least 3 months apart.

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

Special Instructions:

Currently Not Provided

Keywords:

G-CSF

Donor Apheresis

Graft vs. Host Disease

Graft-Versus-Leukemia

Dexamethasone

Transient Lymphopenia

Improved T-Cell Depletion

Recruitment Keyword(s):

Normal Volunteer

Condition(s):

Graft vs Host Disease

Healthy

Lymphopenia

Investigational Drug(s):

None

Investigational Device(s):

None

Intervention(s):

Drug: G-CSF

Supporting Site:

National Heart, Lung and Blood Institute

Contact(s):

Patient Recruitment and Public Liaison Office
Building 61
10 Cloister Court
Bethesda, Maryland 20892-4754
Toll Free: 1-800-411-1222
TTY: 301-594-9774 (local),1-866-411-1010 (toll free)
Fax: 301-480-9793

Electronic Mail:prpl@mail.cc.nih.gov

Citation(s):

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

• Questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.
• Technical questions regarding the Clinical Center web site, please contact the Department of Networks and Applications, CC.

Search The Studies | Help | Questions |
Clinical Center Home | NIH Home

National Institutes of Health Clinical Center Bethesda, Maryland 20892. Last update: 09/16/2008