RecruitingNCT00001529

Improved Methods of Cell Selection for Bone Marrow Transplant Alternatives

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


Sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Enrollment

500 participants

Start Date

Mar 18, 1996

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 60 Years

Plain Language Summary

Simplified for easier understanding

This study is testing improved ways to collect and prepare stem cells from healthy donors that could eventually be used in bone marrow transplants. **You may be eligible if...** - You are a healthy adult between 18 and 60 years of age - You have normal kidney, liver, blood, and heart function - You have adequate veins in your arms for the blood cell collection procedure - You are negative for HIV, hepatitis B and C, and other listed infections **You may NOT be eligible if...** - You have an active infection - You are pregnant or breastfeeding - You have an autoimmune disease requiring treatment - You have had cancer within the last 5 years - You have a significant heart condition or history of blood disorders - You are allergic to G-CSF (a drug used to stimulate stem cell production) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGG-CSF

After medical clearance, volunteers will undergo outpatient mobilization with daily subcutaneous injections of filgrastim (G-CSF). The first dose will be administered at the NIH Clinical Center, with one-hour monitoring for immediate reactions. Volunteers may either return to NIH for daily injections or self-administer at home after training.


Locations(1)

National Institutes of Health Clinical Center

Bethesda, Maryland, United States

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NCT00001529


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