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Graft-Versus-Host Disease
+2

Improved Methods of Cell Selection for Bone Marrow Transplant Alternatives

Sponsored by National Heart, Lung, and Blood Institute (NHLBI)

About this trial

Last updated 7 months ago

Study ID

960049

Status

Recruiting

Type

Observational

Placebo

No

Accepting

18-75 Years
18 to 60 Years
All
All

Trial Timing

Started 29 years ago

What is this trial about?

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. ...

What are the participation requirements?

Yes

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.

No

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.

Locations

Location

Status

Recruiting