Improved Methods of Cell Selection for Bone Marrow Transplant Alternatives

  • STATUS
    Recruiting
Updated on 22 December 2020

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.

Please visit our Patient Recruitment Page for more information.

 

Description

The NHLBI Hematology Branch Stem Cell Transplantation program is exploring ways to make allogeneic transplantation safer and more widely applicable. Prior Hematology Branch transplant protocols have evaluated the strategy of using T cell depleted marrow transplants followed by delayed lymphocyte add-back to control or prevent GVHD while conserving useful donor immune function against residual leukemia and infectious agents. Over the past ten years, a number of increasingly efficient methods have been used to deplete T cells but retain stem cells, and we have shown the safety and utility of the delayed T cell add-back approach. We have also found a positive relationship between administration of higher CD34+ cell doses and outcome. Investigation of highly purified grafts with add-back of specific T cell populations is ongoing, and the ability to test new purification approaches and devices on clinical-scale PBSC products is critical to the continued development of new transplantation approaches in our program. This requires testing the approaches on G-CSF mobilized PBSCs collected by apheresis from healthy donors, since this is the cell source that will be used in all clinical allogeneic transplantation protocols in our program.

Therefore, the primary intent of this protocol is to provide a mechanism for mobilizing, collecting, storing, and analyzing G-CSF mobilized apheresis samples from healthy volunteers. Cells will be used to develop a method of processing the cells that are collected after stimulation with G-CSF, by removing the lymphocytes, which can mediate GVHD while retaining the stem cells which are necessary for hematopoietic reconstitution. At the same time we will study whether G-CSF administration has an effect on the lymphocyte, function which may influence the immune reactions occurring in allogeneic bone marrow transplantation. Furthermore the CD34+ cells collected will be a valuable resource for experimental studies of lymphocyte-stem cell interactions in our laboratory.

 

Please visit our Patient Recruitment Page for more information.

Details
Condition *Healthy Patient Studies, *Healthy Volunteers
Clinical Study IdentifierTX218185
Last Modified on22 December 2020

Eligibility

Yes No Not Sure

Inclusion Criteria

Healthy 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 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
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 and HTLV 1
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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